192



    BTS GUIDELINE

Non-invasive ventilation in acute respiratory failure
British Thoracic Society Standards of Care Committee
.............................................................................................................................

                                                                                                                     Thorax 2002;57:192–211

                             INTRODUCTION                                                A survey of acute admissions in Leeds has sug-
                             Nomenclature                                              gested that, if NIV was used in all patients with
                             Non-invasive ventilation (NIV) refers to the              chronic obstructive pulmonary disease (COPD)
                             provision of ventilatory support through the              with a pH of <7.35 (H+ >45 nmol/l) after initial
                             patient’s upper airway using a mask or similar            medical treatment, a typical district general
                             device. This technique is distinguished from those        hospital serving a population of 250 000 would
                             which bypass the upper airway with a tracheal             expect to treat around 70 patients per year.3
                             tube, laryngeal mask, or tracheostomy and are             • Non-invasive ventilation has been shown to be an
                             therefore considered invasive. In this document             effective treatment for acute hypercapnic respiratory
                             NIV refers to non-invasive positive pressure                failure, particularly in chronic obstructive pulmo-
                             ventilation, and other less commonly used tech-             nary disease. Facilities for NIV should be available 24
                             niques such as external negative pressure or                hours per day in all hospitals likely to admit such
                             rocking beds will not be discussed. (NIPPV is an            patients. [A]
                             alternative abbreviation but it is more cumber-
                             some and involves ambiguity as to whether “N” is             NIV is not suitable for all patients with respira-
                             for “non-invasive” or “nasal”.)                           tory failure. If used indiscriminately, patients who
                                Continuous positive airway pressure (CPAP) in          would be managed more appropriately by tra-
                             this document refers to the non-invasive applica-         cheal intubation will receive suboptimal treat-
                             tion of positive airway pressure, again using a face      ment. Use of NIV in patients in whom it is
                             or nasal mask rather than in conjunction with             unlikely to be beneficial is also undesirable. It is
                             invasive techniques. Although it might be open to         essential that NIV is applied in an appropriate
                             debate as to whether the use of non-invasive              clinical area by appropriately trained staff using
                             CPAP in acute respiratory failure constitutes ven-        the optimal ventilator mode, settings, and inter-
                             tilatory support, it is included in this document         face for that patient with adequate monitoring.
                             because of the confusion which commonly arises
                             between NIV and CPAP in clinical practice.                • NIV should not be used as a substitute for tracheal
                                                                                         intubation and invasive ventilation when the latter is
                             Background                                                  clearly more appropriate. [B]
                             One of the first descriptions of the use of NIV using
                             nasal masks was for the treatment of hypoventila-         Purpose of this document
                             tion at night in patients with neuromuscular              The main aims of this document are to:
                             disease.1 2 This has proved to be so successful that it   • Set standards of care for patients receiving NIV
                             has become widely accepted as the standard                  in acute respiratory failure based on the avail-
                             method of non-invasive ventilation used in pa-              able evidence and define minimum standards
                             tients with chronic hypercapnic respiratory failure         for the provision of an acute NIV service
                             caused by chest wall deformity, neuromuscular
                             disease, or impaired central respiratory drive. It has    • Identify which patients with acute respiratory
                             largely replaced other modalities such as external          failure should be considered for NIV or CPAP
                             negative pressure ventilation and rocking beds.           • Describe the optimal application of different
                                Within a few years of its introduction, NIV was          ventilatory modes and patient interfaces
                             starting to be used in acute hypercapnic respira-
                             tory failure and in patients with abnormal lungs
                             rather than an impaired respiratory pump. Initial         .................................................
                             anecdotal reports were followed by larger series          Abbreviations: AHRF, acute hypercapnic respiratory
Members of BTS               and then by randomised trials. Analysis of these          failure; ARDS, acute respiratory distress syndrome; ASB,
Standards of Care            trials has shown that NIV is a valuable treatment         assisted spontaneous breathing; BMI, body mass index;
Committee: S Baudouin,       for acute hypercapnic respiratory failure, as will        CMV, continuous mandatory ventilation; COPD, chronic
S Blumenthal, B Cooper,      be discussed under the section on Indications. It         obstructive pulmonary disease; CPAP, continuous positive
C Davidson, A Davison,                                                                 airways pressure ; EPAP, expiratory positive airways
                             has a number of potential advantages, particu-
M Elliott, W Kinnear                                                                   pressure; FiO2, fractionated inspired oxygen concentration;
(Chairman), R Paton,         larly the avoidance of tracheal intubation with its       FRC, functional residual capacity; HDU, high dependency
E Sawicka, L Turner          associated mortality and morbidity from prob-             unit; ICU, intensive care unit; IE, inspiratory/expiratory;
(Secretary)                  lems such as pneumonia. Pressure on intensive             IPAP, inspiratory positive airways pressure; IPPV,
.......................      care unit beds is often high, and NIV can be used         intermittent positive pressure ventilation; LTOT, long term
Correspondence to:           in other clinical areas and also at an earlier stage      oxygen therapy; NIV, non-invasive ventilation; OSA,
Dr W Kinnear, University     than tracheal intubation. Intermittent ventilatory        obstructive sleep apnoea; PaCO2, partial pressure of
Hospital, Queen’s Medical    assistance is possible with NIV, allowing gradual         arterial carbon dioxide; PaO2, partial pressure of arterial
Centre, Nottingham                                                                     oxygen; PAV, proportional assist ventilation; PEEP, positive
                             weaning and also normal eating, drinking, and             end expiratory pressure; PEEPi, intrinsic PEEP; PS, pressure
NG7 2UH, UK;
William.Kinnear@             communication. Breaks from ventilatory support            support; SpO2, oxygen saturation; SIMV, synchronised
mail.qmcuh-tr.trent.nhs.uk   can be used for giving nebulised medication,              intermittent mandatory ventilation; S/T,
.......................      physiotherapy, and expectoration.                         spontaneous/timed; V/Q, ventilation perfusion.



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Non-invasive ventilation in acute respiratory failure                                                                                  193


                                                                    acute, acute-on-chronic, or chronic. Although not always
 Key points                                                         clearcut, this distinction is important in deciding on the loca-
                                                                    tion of patient treatment and the most appropriate treatment
 • Non-invasive ventilation (NIV) works – an evidence-based
   verdict                                                          strategy, particularly in type 2 respiratory failure:
 • NIV can be used in any hospital given the following mini-        • Acute hypercapnic respiratory failure: the patient will have
   mum facilities:                                                    no, or minor, evidence of pre-existing respiratory disease
    • A consultant committed to developing an NIV service
                                                                      and arterial blood gas tensions will show a high PaCO2, low
    • Nurses on a respiratory ward, high dependency unit,
                                                                      pH, and normal bicarbonate.
      or intensive care unit who are keen to be involved in
      NIV                                                           • Chronic hypercapnic respiratory failure: evidence of chronic
    • An intensive care unit to provide back up for patients          respiratory disease, high PaCO2, normal pH, high bicarbo-
      who do not improve on NIV                                       nate.
    • A non-invasive ventilator and a selection of masks            • Acute-on-chronic hypercapnic respiratory failure: an acute
 • NIV is particularly indicated in:                                  deterioration in an individual with significant pre-existing
   • COPD with a respiratory acidosis pH 7.25–7.35 (H+                hypercapnic respiratory failure, high PaCO2, low pH, high
     45–56 nmol/l)                                                    bicarbonate.
   • Hypercapnic respiratory failure secondary to chest
                                                                       Knowledge of arterial blood gases is essential before
     wall deformity (scoliosis, thoracoplasty) or neuro-
                                                                    making a decision as to whether NIV is indicated. The patient
     muscular diseases
                                                                    should first be established on appropriate oxygen therapy and
   • Cardiogenic pulmonary oedema unresponsive to
                                                                    the arterial blood gases interpreted in light of the FiO2. A pro-
     CPAP
                                                                    portion of patients who fulfil arterial blood gas criteria for NIV
   • Weaning from tracheal intubation
 • NIV is not indicated in:
                                                                    (see below) at the time of admission to hospital improve rap-
   • Impaired consciousness                                         idly with initial medical treatment with an appropriate FiO2.3 It
   • Severe hypoxaemia                                              will usually then be necessary to repeat measurement of arte-
   • Patients with copious respiratory secretions                   rial blood gas tensions to see if NIV is still needed.
 • The benefits of an acute NIV service are likely to be:              Measurement of arterial blood gas tensions should be con-
    • Fewer patients referred to intensive care for                 sidered in all individuals with breathlessness of sufficient
      intubation                                                    severity to warrant admission to hospital. In certain sub-
    • Shorter stays on intensive care                               groups of patients—for example, asthmatic patients with no
    • Fewer deaths of patients with acute respiratory failure       features of a severe attack—oxygen saturation can be used as
 • Visit the BTS and ARTP websites (brit-thoracic.org.uk and        an initial screen, proceeding to arterial blood gas analysis in
   artp.org.uk) for:                                                those with a SpO2 of <92%. However, it is important to note
    •   The BTS recommendations on NIV                              that oximetry alone may provide false reassurance in patients
    •   An up to date list of non-invasive ventilators              on supplemental oxygen in whom oxygenation is well
    •   Suppliers of equipment for NIV                              maintained in the face of dangerous hypercapnia.
    •   Details of courses and centres offering training in NIV        It should also be appreciated that there is a subgroup of
                                                                    patients with acute-on-chronic hypercapnic respiratory failure
                                                                    who have few symptoms despite severely deranged arterial
• Define minimal monitoring requirements and give guid-              blood gas tensions. In certain patients, particularly those with
  ance on what to do in the event of treatment failure              chest wall deformity or neuromuscular disease, breathlessness
                                                                    may not be a prominent symptom because exercise is limited
• Identify which patients should be referred for long term          by other factors; there should be a low threshold for perform-
  NIV after initial treatment of their acute respiratory failure    ing arterial blood gas measurements in patients with these
• Provide guidance on setting up and running a NIV service          diseases who complain of morning headaches, excessive day-
  including location, staffing levels, provision and mainte-         time sleepiness, general tiredness, malaise, or ankle oedema.
  nance of equipment, minimisation of cross infection, and          Respiratory failure may occasionally present as confusion,
  training                                                          delirium or dementia, and arterial blood gas tensions should
• Facilitate collection of data on the use of NIV in acute respi-   always be considered in such patients.
  ratory failure and provide tools for audit                        • The beneficial effects of NIV have mainly been demonstrated in
• Identify areas requiring further research                           patients with a respiratory acidosis (pH <7.35 (H+ >45 nmol/l)).
                                                                      Knowledge of arterial blood gas tensions is therefore critical to its
   This document is aimed at those who wish to set up an              application. Arterial blood gas tensions should be measured in most
acute NIV service. It is also intended to help those who are          patients with acute breathlessness. [B]
seeking to expand or consolidate existing facilities, particu-      • Arterial blood gas tensions improve rapidly in many patients with
larly where purchasers require evidence of efficacy. The provi-        acute hypercapnic respiratory failure when they receive maximum
sion of long term NIV at home is not covered. NIV can be used         medical treatment and appropriate supplementary oxygen. A repeat
as a treatment for breathlessness in the terminal stages of           sample should usually be taken after a short interval to see if NIV is
progressive neuromuscular disease, but this and other special-        still indicated. [B]
ised applications will not be discussed further. Although NIV
is being introduced into paediatric practice, the published evi-    • There should be a low threshold for measuring arterial blood gas
dence is not yet strong enough for recommendations to be              tensions in patients with neuromuscular diseases, chest wall
made about its use in children.                                       deformity, obesity, or acute confusional states who may be in respi-
                                                                      ratory failure without significant breathlessness. [B]
Definitions                                                           Critical care facilities are in the process of being redefined,
Respiratory failure is defined as a failure to maintain adequate     with dependency levels ranging from 0–3.4 However, for the
gas exchange and is characterised by abnormalities of arterial      purpose of this document, a high dependency unit (HDU) is
blood gas tensions. Type 1 failure is defined by a PaO2 of <8 kPa    defined as a clinical area staffed by appropriately trained
with a normal or low PaCO2. Type 2 failure is defined by a PaO2 of   nurses at a level higher than that of a general ward, usually
<8 kPa and a PaCO2 of >6 kPa. Respiratory failure can be            one member of staff for every two patients (level 2 care). An



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194                                                                                                    BTS Standards of Care Committee



                                           SUMMARY OF RECOMMENDATIONS
 Introduction
 • NIV has been shown to be an effective treatment for acute hypercapnic respiratory failure (AHRF), particularly in chronic
   obstructive pulmonary disease (COPD). Facilities for NIV should be available 24 hours per day in all hospitals likely to
   admit such patients. [A]
 • NIV should not be used as a substitute for tracheal intubation and invasive ventilation when the latter is clearly more appro-
   priate. [B]
 • The beneficial effects of NIV have mainly been demonstrated in patients with a respiratory acidosis (pH <7.35, H+
   >45 nmol/l). Knowledge of arterial blood gas tensions is therefore critical to its application. Arterial blood gas tensions
   should be measured in most patients with acute breathlessness. [B]
 • Arterial blood gas tensions improve rapidly in many patients with AHRF when they receive maximum medical treatment and
   appropriate supplementary oxygen. A repeat sample should usually be taken after a short interval to see if NIV is still indi-
   cated. [B]
 • There should be a low threshold for measuring arterial blood gas tensions in patients with neuromuscular diseases, chest
   wall deformity, obesity, or acute confusional states who may be in respiratory failure without significant breathlessness. [B]

 Ventilators
 • Many different types of ventilator have been used successfully to provide NIV in AHRF; local expertise will influence the
   choice of ventilator used. If possible, a single model of ventilator should be used in any one clinical area for ease of train-
   ing and familiarity of staff with the equipment. [D]
 • Bi-level pressure support ventilators are simpler to use, cheaper, and more flexible than other types of ventilator currently
   available; they have been used in the majority of randomised controlled trials of NIV and are recommended when setting
   up an acute NIV service. [C]
 • Volume controlled ventilators should be available in units wishing to provide a comprehensive acute NIV service. [C]

 Interfaces
 • A selection of different sizes of nasal masks, full-face masks, and nasal pillows should be available for NIV. [C]
 • Both nasal and full-face masks have been used successfully for NIV in AHRF. In the acute setting, a full-face mask should be
   used initially, changing to a nasal mask after 24 hours as the patient improves. [D]

 Indications
 • NIV may be undertaken as a therapeutic trial with a view to tracheal intubation if it fails, or as the ceiling of treatment in
   patients who are not candidates for intubation. A decision about tracheal intubation should be made before commencing
   NIV in every patient. This should be verified as soon as possible with senior medical staff and documented in the case notes.
   [D]
 • NIV should be considered in patients with an acute exacerbation of COPD in whom a respiratory acidosis (pH <7.35, H+
   >45 nmol/l) persists despite maximum medical treatment on controlled oxygen therapy. [A]
 • Continuous positive airway pressure (CPAP) has been shown to be effective in patients with cardiogenic pulmonary oedema
   who remain hypoxic despite maximal medical treatment. NIV should be reserved for patients in whom CPAP is unsuccess-
   ful. [B]
 • NIV is indicated in acute or acute-on-chronic hypercapnic respiratory failure due to chest wall deformity or neuromuscular
   disease. [C]
 • Both CPAP and NIV have been used successfully in patients with decompensated obstructive sleep apnoea. Although no
   direct comparison is available, NIV (in the form of bi-level pressure support) should be used for these patients if a respira-
   tory acidosis is present. [C]
 • CPAP should be used in patients with chest wall trauma who remain hypoxic despite adequate regional anaesthesia and
   high flow oxygen. [C] NIV should not be used routinely. [D]
 • In view of the risk of pneumothorax, patients with chest wall trauma who are treated with CPAP or NIV should be moni-
   tored on the ICU. [D]
 • Many patients with acute pneumonia and hypoxaemia resistant to high flow oxygen will require intubation. In this context,
   trials of CPAP or NIV should only occur in HDU or ICU settings. [D]
 • CPAP improves oxygenation in patients with diffuse pneumonia who remain hypoxic despite maximum medical treatment.
   NIV can be used as an alternative to tracheal intubation if the patient becomes hypercapnic. [C] In this context, patients
   who would be candidates for intubation if NIV fails should only received NIV in an ICU. [D]
 • NIV should not be used routinely in acute asthma. [C]
 • A trial of NIV may be undertaken in patients with a respiratory acidosis (pH <7.35, H+ >45 nmol/l) secondary to an acute
   exacerbation of bronchiectasis, but excessive secretions are likely to limit its effectiveness and it should not be used routinely
   in bronchiectasis. [C]
 • NIV has been used in a variety of other conditions (such as acute respiratory distress syndrome, postoperative and post-
   transplantation respiratory failure) with reduced intubation rates, ICU stay and mortality. In this context, patients who would
   be considered for intubation if NIV fails should only receive NIV in ICU. [D]
 • NIV has been used successfully to wean patients from invasive ventilation, and should be used when conventional wean-
   ing strategies fail. [B]




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Non-invasive ventilation in acute respiratory failure                                                                             195



                                        SUMMARY OF RECOMMENDATIONS (Continued)
 Contraindications
 • NIV should not be used in patients after recent facial or upper airway surgery, in the presence of facial abnormalities such
   as burns or trauma, if there is fixed obstruction of the upper airway, or if the patient is vomiting. [D]
 • Contraindications to NIV include recent upper gastrointestinal surgery, inability to protect the airway, copious respiratory
   secretions, life threatening hypoxaemia, severe co-morbidity, confusion/agitation, or bowel obstruction. NIV can be used
   in the presence of these contraindications provided contingency plans for tracheal intubation have been made, or if a deci-
   sion has been made not to proceed to invasive ventilation. [C]
 • Although NIV has been used successfully in the presence of a pneumothorax, in most patients with a pneumothorax an
   intercostal drain should be inserted before commencing NIV. [C]


 Monitoring
 • Clinical evaluation of the patient should include assessment of patient comfort, conscious level, chest wall motion, acces-
   sory muscle recruitment, coordination of respiratory effort with the ventilator, respiratory rate and heart rate. Patients
   receiving NIV should be reviewed regularly to assess their response to treatment and to optimise the ventilator settings. [D]
 • The need for arterial blood gas analysis will be governed by the patient’s clinical progress but should be measured in most
   patients after 1–2 hours of NIV and after 4–6 hours if the earlier sample showed little improvement. If there has been no
   improvement in PaCO2 and pH after this period, despite optimal ventilator settings, NIV should be discontinued and inva-
   sive ventilation considered. [B]
 • Oxygen saturation should be monitored continuously for at least 24 hours after commencing NIV and supplementary oxy-
   gen administered to maintain saturations between 85% and 90%. [C]
 • Breaks from NIV should be made for drugs, physiotherapy, meals, etc. Patients who show benefit from NIV in the first few
   hours should be ventilated for as much as possible during the first 24 hours, or until improving. [B]
 • All patients who have been treated with NIV for AHRF should undergo spirometric testing and arterial blood gas analysis
   while breathing air before discharge. [C]
 • All patients with spinal cord lesions, neuromuscular disease, chest wall deformity, or morbid obesity who develop AHRF
   should be referred for assessment to a centre providing long term ventilation at home. [C]


 Setting up an acute NIV service
 • A named consultant with appropriate training should have overall responsibility for the NIV service. This will usually be a
   consultant respiratory physician. [D]
 • NIV can be provided in a number of locations including the ICU, a high dependency unit (HDU), or a respiratory ward.
   However, each hospital should have a specific designated area with an available cohort of staff with appropriate experi-
   ence, together with structures to ensure that patients requiring NIV can be transferred to this area with the minimum of delay.
   [C]
 • The clinical area in which a patient is treated with NIV will be influenced by several factors including their clinical state,
   whether they will be intubated if NIV fails, and the availability of beds. Taking into account the overall clinical picture,
   patients with more severe acidosis (pH <7.30, H+ >50 nmol/l) should be managed in a higher dependency area such as
   an HDU or ICU, as should those in whom improvement in clinical state and arterial blood gas tensions is not seen after 1–2
   hours of NIV on a respiratory ward. [C]
 • Patients with AHRF from a cause where the role of NIV is not yet clearly established (such as pneumonia, ARDS, asthma)
   should only receive NIV in an HDU or ICU where facilities for immediate tracheal intubation are available. [C]
 • There should be a clear protocol for the on-call medical staff as to the indications for NIV, how to initiate treatment, and
   who has continuing responsibility for supervision of the patient. [D]
 • Trained ICU staff, doctors, physiotherapists, lung function technicians, and nurses can successfully set up and maintain NIV.
   When setting up an acute NIV service, it is recommended that NIV be initiated and run by nursing staff. [C]
 • All staff involved in an acute NIV service should receive training appropriate to their baseline knowledge and role in pro-
   viding the service. Training in NIV should be available for consultants in respiratory medicine and should be included in all
   specialist registrar training programmes. [D]
 • A training programme for the provision of an NIV service should provide a combination of knowledge based learning sup-
   ported by clinical experience in the workplace. [D]
 • The use of NIV in acute respiratory failure should be the subject of regular audit. In addition to collection of data on patients
   receiving NIV, details of the number of patients admitted with acute hypercapnic respiratory failure will be required,
   together with the use of invasive ventilation in these patients. [D]


 Infection control and equipment safety
 • Reusable masks and exhalation valves should be reprocessed in an automated washer/disinfector/drier machine after dis-
   assembly into their component parts. [C]
 • A bacterial filter should be attached to the ventilator outlet during NIV and the external surface of the ventilator cleaned
   between patients. [C]
 • Maintenance and electrical safety checks on ventilators should be undertaken according to the manufacturers’ recommen-
   dations, and at least annually. [D]




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196                                                                                                 BTS Standards of Care Committee


intensive care unit (ICU) is defined as a unit with facilities for   of the lungs and chest wall. In volume control, tidal volume is
the management of the intubated patient, usually with a             set and the resulting pressure required to deliver this volume
nurse:patient ratio of 1:1 (level 3 care). A general respiratory    is determined by circuit compliance and thoracic mechanics.
ward is defined as a ward admitting unselected medical, but          On NIV machines CMV may be referred to as timed ventilation
mainly respiratory, patients.                                       (T). Some ventilators allow the rise time to be ramped from a
                                                                    slow to a rapid increase. This facility is provided for patient
Methodology                                                         comfort. The ventilator may, however, fail to reach the target
The Standards of Care Committee of the British Thoracic             pressure when the inspiratory period is short and a prolonged
Society (BTS) selected the topic as the subject for preparation     rise time is selected, resulting in a smaller tidal volume.
of a guideline and a subcommittee was convened. This was a
multidisciplinary group including clinical experts, medical,        Assist/control ventilation
nursing, physiotherapy, and lung function staff. Every              In assist/control mode (ACV) a preset number of mandatory
subcommittee member completed a form declaring any                  breaths per minute will be delivered in the absence of patient
potential conflicts of interest; these forms were held at the        effort. As with CMV, ventilator delivered breaths are deter-
BTS offices and were tabled at meetings of the subcommittee.         mined by setting volume or pressure and the inspiration and
   A literature search was conducted on Medline, Embase and         expiration durations. Patient triggering is permitted but the
the Cochrane database covering 1966–2000, and further               machine delivers an identical breath to mandatory breaths. To
papers were obtained from the resulting reference lists and         avoid excessive inflation through breath stacking, the ventila-
from the personal collections of members of the subcommit-          tor is programmed to fail to deliver within a variable “lock
tee. Keywords used were “non-invasive ventilation”, “me-            out” period. As respiratory rate is increased, the lock out
chanical ventilation”, “positive pressure ventilation”, “non-       period must shorten. On some ventilators, setting a long
invasive positive pressure ventilation”, “nasal intermittent        expiratory time also sets a long lock out and may lead to poor
positive pressure ventilation”, “bi-level positive airway pres-     patient tolerance. Triggered breaths delay the next machine
sure”, “pressure-controlled ventilation”, “volume-controlled        determined breath so that there is said to be synchronisation
ventilation”, “ventilatory support”, “continuous positive air-      between patient triggered and machine delivered breaths
way pressure”, and “CPAP”. Searches were limited to human           (SIMV). This mode is sometimes referred to as spontaneous/
studies and English language.                                       timed (S/T) or IE mode on NIV machines.
   All abstracts were reviewed and articles were selected for
                                                                    Assisted spontaneous breathing (pressure support)
inclusion on the basis of containing original patient data on
                                                                    In assisted spontaneous breathing (ASB) the patient’s
the use of NIV or CPAP in adults with acute respiratory failure.
                                                                    respiratory effort triggers the ventilator both on and off. Res-
Evidence tables were constructed and the recommendations
                                                                    piratory frequency and the timing of each breath are therefore
were graded by at least two members of the subcommittee
                                                                    determined by the patient. As this mode usually involves set-
according to the 2000 version of the Scottish Intercollegiate
                                                                    ting pressure, it is often termed pressure support (PS). If the
Guideleine Network (SIGN) criteria (appendix 1). After the
                                                                    patient fails to make respiratory effort, no respiratory
members had prepared their sections of this document, it was
                                                                    assistance will occur, although many manufactures now
reviewed at two whole day meetings of the subcommittee and
                                                                    incorporate a back up rate of 6–8 breaths per minute.
the grading for each recommendation was agreed. Further
expert opinions were obtained (listed at the end of the docu-       Continuous positive airway pressure
ment) and, after revision, the recommendations were pre-            CPAP is employed in patients with acute respiratory failure to
sented to a national meeting of the BTS. A draft of the guide-      correct hypoxaemia. It permits a higher inspired oxygen con-
line was available on the BTS website for a period of 3 months      tent than other methods of oxygen supplementation, in-
for comment. The guidelines were reviewed by the members of         creases mean airway pressure, and will improve ventilation to
the Standards of Care Committee, the Clinical Effectiveness         collapsed areas of the lung. The recruitment of underventi-
and Evaluation Unit of the Royal College of Physicians of Lon-      lated lung is similar to the use of positive end expiratory pres-
don, the Intensive Care Society, the Faculty of Accident and        sure (PEEP) in the intubated mechanically ventilated patient.
Emergency Medicine, the UK Home Mechanical Ventilation                 CPAP also unloads the inspiratory muscles and thereby
Providers Group, and the Association of Respiratory Techni-         reduces inspiratory work, although in hyperinflated patients
cians and Physiologists.                                            with airflow obstruction any further increase in lung volume
   Further editorial changes were made in the light of              produced by CPAP may have an adverse effect on the function
comments received during the above process and from                 of the inspiratory muscles. In cases of respiratory failure due
reviewers for Thorax; editorial control remained independent        to exacerbations of COPD, the offsetting of intrinsic PEEP by
of all sources of funding for the guideline. The guideline group    CPAP (see below) may reduce ventilatory work resulting in a
will be reconvened every 2 years to update the document and         slowing of respiratory rate, an increase in alveolar ventilation,
an updated version will be available on the BTS website (brit-      and a fall in PaCO2. Although this might be considered the
thoracic.org.uk).                                                   result of respiratory assistance, conventionally CPAP is not
                                                                    considered respiratory support and its main indication is to
MODES OF NON-INVASIVE VENTILATION                                   correct hypoxaemia.
The terminology used to describe different modes of NIV can            Flow generators employed in CPAP need to be capable of
be confusing. The following section describes the principal         maintaining the desired pressure throughout the respiratory
modes. There is no standardisation between manufacturers,           cycle. In domiciliary practice, as in the treatment of
and unfortunately each mode may be called by different              obstructive sleep apnoea (OSA), generators capable of low
names on different ventilators.                                     flows are sufficient as minute ventilation and peak inspiratory
                                                                    flow are low. In the distressed COPD patient the increased
Controlled mechanical ventilation                                   minute ventilation, high frequency, and short inspiratory time
In the mandatory controlled mechanical ventilation (CMV)            may result in peak inspiratory flow rates in excess of 60 l/min.
mode, full ventilatory support is provided and no patient effort    High flows are therefore required to prevent a fall in applied
is required. Inflation pressure or tidal volume is set, as is fre-   pressure. Some of the newer non-invasive ventilators have a
quency and the timing of each breath. In pressure control, the      CPAP mode capable of delivering adequate flow rates. Other
resulting tidal volume depends upon the resistance to flow of        CPAP generators require a high pressure oxygen supply. Whis-
ventilator tubing, any airflow limitation, and the compliance        per flow systems entrain room air by the Venturi effect and


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Non-invasive ventilation in acute respiratory failure                                                                                   197


have a FiO2 adjustable above a minimum 40%. The Draeger           timed mode as the glottic aperture will not be in phase with
system provides for a lower FiO2 as air and oxygen is             mechanical breaths,11 12 is probably only of relevance to domi-
independently set. A reservoir prevents a fall in mask pressure   ciliary practice.
during inspiration. CPAP masks are usually pressurised by
inserting a one way exhalation valve.                             Pressure assist-control ventilators
                                                                  Technical developments such as microprocessor controlled
Bi-level pressure support                                         valves have led to most NIV ventilators now being pressure
In NIV, pressure support and CPAP are often used in combina-      controlled flow generators. Smith and Shneerson carried out a
tion as bi-level pressure support. Ventilation is produced by     bench comparison of ventilators and showed the expected
the inspiratory positive airway pressure (IPAP), while the        better leak compensation of pressure control.13 The de-
expiratory positive airway pressure (EPAP) recruits underven-     accelerating flow profile of a pressure controlled breath may
tilated lung and offsets intrinsic PEEP (with beneficial effects   result in better distribution of ventilation while, in the ICU,
on triggering). The EPAP also serves to vent exhaled gas          recognition of subtle forms of ventilator associated lung dam-
through the exhaust port (see below).                             age has resulted in a move to pressure limited small volume
                                                                  ventilation. This is typified by the recruiting “permissive”
Proportional assist ventilation                                   hypercapnia ventilation strategies now recommended in acute
Proportional assist ventilation (PAV) is an alternative tech-     lung injury.14
nique in which both flow—to counter resistance—and                 Bi-level assisted spontaneous breathing ventilators
volume—to counter compliance—are independently adjusted.          Ventilators used for non-invasive assisted spontaneous breath-
It may improve patient comfort and so improve success and         ing (pressure support) usually use two different pressures:
compliance with acute NIV.5                                       inspiratory positive airway pressure (IPAP) to assist inspira-
                                                                  tion, and a lower expiratory positive airway pressure (EPAP).
                                                                  As with other pressure controlled ventilators, compensation is
NON-INVASIVE VENTILATORS
                                                                  made for air leakage. EPAP eliminates exhaled air through the
Ventilators employed in NIV range from ICU ventilators with
                                                                  expiratory port, thus reducing re-breathing, encourages lung
full monitoring and alarm systems normally employed in the
                                                                  recruitment, and stents open the upper airway. Most recent
intubated patient, to light weight, free standing devices with
                                                                  randomised controlled trials of NIV in AHRF have used this
limited alarm systems specifically designed for non-invasive
                                                                  mode of ventilation. One study in patients with acute COPD
respiratory support. Life support ICU ventilators separate the
                                                                  failed to demonstrate significant benefit with bi-level over
inspiratory and expiratory gas mixtures. This prevents
                                                                  pressure support15 while, in patients with stable neuromusc-
rebreathing and allows monitoring of inspiratory pressure and
                                                                  ular disease, the addition of PEEP to PS increased overnight
exhaled minute ventilation on which monitoring and alarm
                                                                  oxygenation.16 Appendini et al also found greater reduction in
limits are based. In NIV single tubing is usually employed, and
                                                                  work of breathing with the addition of PEEP in acute COPD.17
exhalation is either active (the ventilator opens an exhalation
                                                                  In patients with COPD, EPAP overcomes the effects of intrin-
valve—for example, NIPPY 1 or Breas PV 401) or passive
                                                                  sic PEEP (see below). The significant re-breathing potential of
(exhaled air is encouraged to exit an exhaust valve or port by
                                                                  these ventilators has been reported, only eliminated by exces-
continuous bias flow (EPAP) from the ventilator). Exhalation
                                                                  sively high expiratory pressure (EPAP). Machines were also
valves may increase work of breathing, and normally used
                                                                  variable in their speed of response and in the time to reach set
EPAP levels (3–5 cm H2O) do not completely eliminate
                                                                  pressure.6
rebreathing during bi-level pressure support, especially when
respiratory frequency increases.6 This therefore needs to be      • Many different types of ventilator have been used successfully to pro-
considered in the tachypnoeic anxious individual who fails to        vide NIV in AHRF; local expertise will influence the choice of venti-
improve or develops worsening hypercapnia. It is important           lator used. If possible, a single model of ventilator should be used in
that exhalation ports or valves are fitted and functioning            any one clinical area for ease of training and familiarity of staff with
properly. Occlusion of the exhaust port—for instance, by             the equipment. [D]
sputum—can exacerbate hypercapnia through rebreathing.7           • Bi-level pressure support ventilators are simpler to use, cheaper, and
                                                                    more flexible than other types of ventilator currently available; they
Volume assist-control ventilators                                   have been used in the majority of randomised controlled trials of
Volume controlled ventilators predominated in the past but          NIV and are recommended when setting up an acute NIV service.
have largely been replaced by pressure devices. Some air leak       [C]
is invariable with NIV, either from the mask or through the       • Volume controlled ventilators should be available in units wishing to
mouth, and with a volume controlled ventilator tidal volumes        provide a comprehensive acute NIV service. [C]
must be arbitrarily increased to compensate for this. Volume
and pressure control modes have both been shown to be             Triggering
effective in COPD but few comparative studies have been           Ventilator triggering is critical to the success of NIV in both
reported. Vittaca et al8 found no difference in outcome whether   spontaneous and assist/control modes.18 It is a complex field
volume or pressure ventilators were used in AHRF. Girault et al   and involves both sensing inspiratory effort as well as
found greater respiratory muscle rest with volume assist, but     determining the end of inspiration. In assist/control mode,
at the cost of greater patient discomfort compared with PS.9      inspiratory support is given for a predetermined set period—
The addition of PEEP to PS was not investigated, however,         for instance, a pressure setting of 20 cm H2O for 1.2 seconds
which might have reduced work of breathing. Some experts          (Nippy 1 and 2, Sullivan VPAP). On other machines the sens-
would wish to use a volume ventilator for the more difficult       ing of the end of inspiration may be varied by setting the ven-
patient and Schoenhofer et al reported that some patients         tilator to switch to expiration at 20–80% of the maximum
failed to be managed with pressure timed support but were         inspiratory flow (Breas PV 401, Puritan Bennett). In others the
successfully treated by volume control.10 One explanation         triggers are preset by the manufacturer (Respironics BiPAP) or
might be that volume control is better at ensuring alveolar       only the inspiratory trigger is adjustable. Trigger sensitivity
ventilation when compliance or airway resistance changes.         and ventilator response times are generally good with NIV
This is probably not important in acute NIV as patient moni-      machines,19 although some ventilators tested showed poor
toring would detect failure to correct hypercapnia. Similarly,    trigger sensitivity when simulated inspiratory effort was
glottic narrowing, which may limit the effectiveness of the       small.



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198                                                                                                      BTS Standards of Care Committee


   Bi-level ventilators employ flow sensors which detect a
change in the machine produced bias flow. Improved patient               Box 1 Features of a ventilator suitable for NIV in
comfort probably explains the widespread adoption of bi-level           hospital
ventilators. Patient-ventilator asynchrony may still result from        Essential
undetected inspiratory effort, a delay in response to the start         •   Pressure controlled
of inspiration or in the detection of the end of a breath, espe-        •   Pressure capability of at least 30 cm H2O
cially in the presence of excessive leakage.9 11 17 20 These differ-    •   Capable of supporting inspiratory flows of at least 60 l/min
ent causes may be difficult to resolve. An alternative is to             •   Assist-control and bi-level pressure support modes
employ the timed or ACV mode which may be set up to provide             •   Rate capability of at least 40 breaths/min
mandatory breaths similar to the patient’s unsupported venti-           •   Sensitive flow triggers
latory pattern. The timed mode is particularly important in             •   Disconnection alarm
patients with advanced acute respiratory failure who may                Desirable
cease making spontaneous effort when “captured”, or in
                                                                        •   Short pressure rise time capability
patients who are normally dependent on hypoxic respiratory              •   Adjustable pressure rise time
drive. The patient with neuromuscular disease may also                  •   Adjustable inspiratory trigger
require timed support as respiratory effort may be insufficient          •   Adjustable expiratory trigger
to trigger a breath, particularly during sleep.12                       •   Adjustable inspiratory-expiratory ratio in assist-control
   Intrinsic positive end expiratory positive pressure (PEEPi)              mode
is commonly observed in patients with airflow limitation. In             •   Temporary alarm cancellation facility
the intubated paralysed individual it can be measured by                •   Internal battery with power for at least 1 hour
transient occlusion of the airway and reflects the recoil                •   Accessible control panel with cover or lock-out facility
                                                                        •   Simple control knobs
pressure of the overinflated lung. In the spontaneously
                                                                        •   LED/LCD displays
breathing patient PEEPi may be overestimated as abdominal
muscle contraction contributes to the positive intrathoracic
pressure at end expiration.17 PEEPi is overcome by isometric
respiratory muscle contraction before airflow can begin and,            alarms that indicate settings which cannot be achieved by the
for the patient receiving NIV, a triggered breath initiated. By        machine settings such as a larger tidal volume and short
offsetting intrinsic PEEP, EPAP therefore helps triggering17 19        inspiratory time. External alarms can be added to the ventila-
and, by reducing perceived effort, it improves comfort.                tor circuit; these are particularly important for ventilator
Although PEEPi may be 10–15 cm H2O in patients with severe             dependent patients.
acute COPD, levels of EPAP of >5 cm H2O are rarely
tolerated.17                                                           Minimum specifications for NIV ventilators
                                                                       There is a bewildering choice of ventilators from which to
Oxygen                                                                 choose when setting up an NIV service. In the setting of acute
NIV ventilators entrain room air and, on most machines, oxy-           respiratory failure a significant proportion of the patients will
gen enrichment requires oxygen to be fed proximally into the           have COPD. Most studies which have shown improved
circuit or directly into the mask. An FiO2 of about 35% can be         survival in COPD with NIV have used ventilators where
achieved, but the flow rate of oxygen required will vary                inspiratory pressure is the controlled variable, and a bi-level
depending on the flow rate of air from the ventilator as it             device is probably the preferred mode for this group of
attempts to reach the set pressure, and the magnitude of any           patients. An assist/control mode will also be necessary for
leaks in the circuit. An oxygen analyser inserted into the ven-        some of these patients, and also for those with other diseases
tilator tubing gives unreliable information and an oximeter to         who are likely to make little respiratory effort once established
guide oxygen enrichment is more reliable. Higher enrichment            on NIV. These requirements can be provided by two different
requires premixing which necessitates a high pressure oxygen           devices or combined in a single ventilator. Features of a venti-
supply. This is only available with ventilators designed for ICU       lator suitable for NIV in hospital are shown in box 1.
use such as the Respironics Vision or volume control                      Different ventilatory modes, the ability to change trigger
machines.                                                              sensitivity, to vary rise time to the set pressure, and to adjust
                                                                       the sensing of the end of inspiration are just some of the fea-
Humidification                                                         tures of newer ventilators. It must be borne in mind that these
Humidification is not normally necessary during NIV. Use of             sophisticated options require more operator understanding
heated humidifiers or heat/moisture exchangers significantly             than is often available, although by increasing comfort they
alters the compliance and resistance of the circuit and, in par-       may increase tolerance. Use of a single model of ventilator (or
ticular, can impair the function of inspiratory and expiratory         at least a small number of different types) in any one hospital
triggers.                                                              is advisable for ease of training staff.
                                                                          An updated list of the features of non-invasive ventilators is
Alarms                                                                 available on the ARTP website (artp.org.uk).
Alarms on NIV ventilators are based on pressure, flow, or vol-
ume. A low pressure alarm detects disconnection or excessive           PATIENT-VENTILATOR INTERFACES
leakage which prevents the ventilator achieving the set                The sophistication and variety of interfaces reflects how prob-
pressure. High pressure alarms may be set on volume control-           lematic this aspect of NIV can be. Approximately 20–30% of
led ventilators to warn of excessively high pressures (which           patients with acute respiratory failure cannot be managed by
may arise if the patient’s condition changes and they become           NIV.21 22 In some, asynchrony between patient and ventilator is
more difficult to inflate, or when a large tidal volume is set           the cause and this may result from poor mask fit. In these cir-
with a short inspiratory time). Flow alarms are more                   cumstances, inspiratory effort and end inspiration may fail to
informative and can warn of changing leakage, worsening                be detected. After semi-continuous use over several days skin
airflow obstruction, or partially occluded ventilator tubing. By        ulceration, particularly over the nasal bridge, occurs. A barrier
measuring flow and assuming constant leakage, some devices              dressing may be used from the outset to reduce the risk of this
compute tidal volume and hence minute volume; alarm limits             complication. Overtightening the head gear in an attempt to
can then be set and this type of ventilator offers greater moni-       reduce leakage exacerbates skin damage with resulting poor
toring potential. Volume controlled ventilators may have               compliance. Mask fit is therefore important for comfort and to


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Non-invasive ventilation in acute respiratory failure                                                                                     199


ensure effective ventilatory support. Training is required for          (2) As a trial with a view to intubation if NIV fails.
any therapist involved with NIV. More sophisticated “off the            (3) As the ceiling of treatment in patients who are not candi-
shelf ” masks are available with cushioned gel surrounding the          dates for intubation .
nasal interface (Gold Seal, Respironics) or comfort flaps that             A decision about intubation if NIV fails should be made
limit leakage. Alternatively, horizontal rather then vertical           early in each patient, taking into consideration the severity of
catheter mounts (Blue Horizon, Tiara Medical), nasal plugs              the underlying disease and previous level of disability, and
(Adams circuit, Nellcor Puritan Bennett or Mallinkrodt), or             documented in the notes. The wishes of the patients and their
nasal slings (Monarch, Respironics) are available. Although             carers should also be taken into account. This decision should
the latter may be more comfortable, they leak and are more              be verified by senior medical staff and, if appropriate, consul-
easily displaced, particularly during sleep. Individually               tation with ICU staff should be made at an early stage.
moulded masks are popular in some centres and heat sensitive
plastics that mould to the face are now commercially                    • NIV may be undertaken as a therapeutic trial with a view to
produced (Profile, Respironics). Laser scanning to produce                 tracheal intubation if it fails, or as the ceiling of treatment in
individual interfaces may become available. At present, the               patients who are not candidates for intubation. A decision about
cost of these alternative designs restricts them to patients              tracheal intubation should be made before commencing NIV in
requiring long term NIV.                                                  every patient. This should be verified as soon as possible with senior
   A degree of air leakage through the mouth is common and                medical staff and documented in the case notes. [D]
may be significant during sleep.23 If chin straps are ineffective
in reducing leakage, a full face mask must be employed.                 COPD
Acrylic masks for CPAP can be used but these often produce              NIV
skin ulceration and leakage is severe in edentulous subjects.           A number of prospective randomised controlled trials of NIV
As with nasal masks, a better fit is obtained if dentures are left       have been published, predominantly in patients with acute
in place. Full-face masks may be useful in the uncooperative            exacerbations of COPD. The studies performed in the
patient, but nasal masks are generally preferable because they          ICU21 22 25 26 show that NIV is feasible and that the tracheal
are less claustrophobic and allow eating, drinking, and speech.         intubation rate is substantially reduced. In the study by
Air swallowing is also more problematic with a full-face mask           Brochard et al21 most of the excess mortality and complica-
and sometimes produces severe abdominal distension. This                tions, particularly pneumonia, were attributed to intubation.
may limit their use in patients with recent abdominal surgery.          These data suggest that NIV may be superior to mechanical
Occasional patients are unable to tolerate any mask. Oral               ventilation but, importantly, this was a highly selected group
interfaces based on a snorkel design are available but require          of patients with the majority being excluded from the study.
determination on the part of the patient. In patients who are           Kramer et al22 also noted a reduction in intubation rate,
intolerant of NIV because of nasal obstruction, nasal stents            particularly in the subgroup with COPD, but with no
can be inserted to restore the patency of the upper airway.24 An        difference in mortality. The study by Celikel et al25 showed a
updated list of the features of interfaces is available on the          more rapid improvement in various physiological parameters
ARTP website (artp.org.uk).                                             but there was no difference in intubation rate or survival.
• A selection of different sizes of nasal masks, full-face masks, and   However, a number of patients in the conventionally treated
  nasal pillows should be available for NIV. [C]                        group also received NIV because of clinical deterioration. Mar-
                                                                        tin et al26 have recently reported a prospective randomised
• Both nasal and full-face masks have been used successfully for NIV
                                                                        controlled trial comparing NIV with usual medical care in 61
  in AHRF. In the acute setting, a full-face mask should be used ini-
                                                                        patients including 23 with COPD. In common with other
  tially, changing to a nasal mask after 24 hours as the patient
                                                                        studies there was a significant reduction in intubation rate,
  improves. [D]
                                                                        but there was no difference in mortality. However, generalisa-
                                                                        tion of these results to the UK, where NIV is usually performed
INDICATIONS FOR NIV                                                     on general wards, is uncertain.
There have been a number of uncontrolled studies describing                Prospective randomised controlled trials of NIV outside the
the use of NIV in a wide range of different conditions.                 ICU27–30 have shown varying results. In the trial by Bott et al29
Controlled trials have predominantly, but not exclusively, been         research staff supernumerary to the normal ward complement
carried out in patients with COPD. None of these trials has             initiated NIV. On an intention to treat analysis there was no
used “sham” NIV as control therapy. Reservations have been              difference between the two groups, but when those unable to
expressed that some of the benefit seen with NIV could reflect            tolerate NIV were excluded a significant survival benefit was
the attention given to the patients during the administration           seen in the NIV group. In the study by Barbe et al28 the lack of
of NIV. A further possibility is that the discomfort of the mask        difference between the two groups is not surprising as, given
merely prevents the patient from falling asleep; gas exchange           the modest level of acidosis at presentation, the majority were
deteriorates during sleep and supplementary oxygen is more              likely to improve with standard treatment. Wood et al27 found
likely to produce rises in PaCO2 than when the patient is awake.        a non-significant trend towards increased mortality in those
Double blind, placebo controlled trials of NIV in AHRF are              given NIV (4/16 v 0/11, p=0.123) which was attributed to
unlikely ever to be performed, and conclusions about the indi-          delays in intubation. It is difficult to draw many conclusions
cations for NIV from the evidence available must therefore be           from this study as the two groups were poorly matched and
made with caution.                                                      the numbers small. In particular, there were more patients
   There are very few randomised control trials of CPAP in              with pneumonia in the NIV group.
acute respiratory failure, and most have focused on the treat-             A multicentre randomised controlled trial of NIV in acute
ment of cardiogenic pulmonary oedema. There is also a lack of           exacerbations of COPD (n=236) on general respiratory wards
trials comparing CPAP with both NIV and best medical                    in 13 centres has recently been reported.30 NIV was applied by
therapy. Only one randomised controlled trial, again in                 the usual ward staff according to a simple protocol.
cardiogenic pulmonary oedema, is available which compares               “Treatment failure”, a surrogate for the need for intubation
all three treatments.                                                   defined by a priori criteria, was reduced from 27% to 15% by
   There are three levels at which NIV may be used:                     NIV (p<0.05). In-hospital mortality was also reduced from
(1) As a holding measure to assist ventilation in patients at an        20% to 10% (p<0.05). Subgroup analysis suggested that the
earlier stage than that at which tracheal intubation would be           outcome in patients with pH <7.30 (H+ >50 nmol/l) after ini-
considered.                                                             tial treatment was inferior to that in the studies performed in



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200                                                                                                        BTS Standards of Care Committee


the ICU; these patients are probably best managed in a higher          NIV
dependency setting with individually tailored ventilation.             Several case reports and series43–51 have described the use of
Staff training and support are crucial wherever NIV is                 NIV in pulmonary oedema. Mortality in the series varied from
performed, and operator expertise more than any other factor           0% to 22% and intubation rates from 0% to 44%. Two recent
is likely to determine the success or otherwise of NIV.                randomised controlled trials have given conflicting results.
   It is important to note that all the randomised controlled          Masip et al52 showed a more rapid clinical improvement when
trials have excluded patients deemed to warrant immediate              NIV was compared with oxygen therapy in acute cardiogenic
intubation and mechanical ventilation and there has been no            pulmonary oedema, with reduced intubation rates but no
direct comparison between NIV and invasive ventilation from            overall difference in mortality, whereas Sharon et al53 found a
the outset in COPD.                                                    worse outcome than with intravenous nitrate infusion.
   In addition to these prospective randomised controlled
trials, there have been two studies comparing patients treated         CPAP v NIV
with NIV with historical controls treated conventionally or            One randomised controlled trial of 27 patients compared CPAP
with invasive mechanical ventilation. These have shown a               with NIV.38 The study was prematurely terminated due to an
reduction in intubation rate,31 no difference in hospital              increased incidence of myocardial infarction in the NIV group.
mortality, but a survival advantage for non-invasively venti-          The interim analysis found no difference in hospital mortality
lated patients becoming apparent after discharge at 3 months           (one death in the NIV group, two deaths in the CPAP group) or
and 1 year.31 32                                                       need for intubation (one in each group). Comparison of the
                                                                       two groups at entry showed that more patients with chest
CPAP
                                                                       pain were entered into the NIV limb, raising the possibility of
There are no randomised controlled trials of CPAP in the
                                                                       entry mismatch as an explanation for the higher number of
treatment of respiratory failure in COPD. A number of case
                                                                       myocardial infarctions in the NIV treated group.
series have reported beneficial affects of CPAP, including an
increase in PaO2, decrease in PaCO2, and a fall in respiratory         • CPAP has been shown to be effective in patients with cardiogenic
rate.17 33–36 Two of the series35 36 reported an intubation rate of      pulmonary oedema who remain hypoxic despite maximal medical
10–30% despite CPAP. The trials of NIV in COPD suggest that              treatment. NIV should be reserved for patients in whom CPAP is
CPAP may now be an irrelevant treatment in patients with                 unsuccessful. [B]
COPD. However, CPAP remains more readily available, is
                                                                       Chest wall deformity/neuromuscular disease
cheaper, and requires less training for use. There is some evi-
                                                                       Successful NIV has been described54 and, given the success in
dence for the use of CPAP in COPD and randomised controlled
                                                                       chronic ventilatory failure, NIV should be considered the
trials comparing CPAP with NIV could be justified. Studies on
                                                                       treatment of choice in decompensated ventilatory failure due
the benefits or risks of EPAP in NIV are also needed.
                                                                       to chest wall deformity and neuromuscular disease. There are
Doxapram                                                               no randomised controlled trials and very few case reports of
Angus et al37 compared doxapram with NIV; NIV was found to             NIV in these patient groups, and it is now very unlikely that a
be more effective and the protocol had to be changed to allow          randomised controlled trial will ever be performed. There is
the introduction of ventilatory support following three deaths         good evidence of long term survival benefit with home venti-
in the doxapram group. Doxapram may be used while the                  lation, with 5 year survival of around 80%.55 The decision to
patient is transferred to an area where NIV can be started, if         use NIV will, however, depend upon the severity of the venti-
NIV is not available, or if it cannot be tolerated by the patient.     latory failure, the presence or absence of bulbar involvement,
In some patients who remain drowsy on NIV or who are par-              and the availability of other effective treatments—for exam-
ticularly prone to carbon dioxide retention it may be necessary        ple, in myasthenia gravis and Guillain-Barré syndrome.
to combine NIV and doxapram.                                           • NIV is indicated in acute or acute-on-chronic hypercapnic respira-
• NIV should be considered in patients with an acute exacerbation of     tory failure due to chest wall deformity or neuromuscular disease.
   COPD in whom a respiratory acidosis (pH <7.35, H+ >45 nmol/l)         [C]
   persists despite maximum medical treatment on controlled oxygen
                                                                       Decompensated obstructive sleep apnoea
   therapy. [A]
                                                                       NIV has been used successfully in this condition56 and patients
Cardiogenic pulmonary oedema                                           admitted acutely with hypercapnic respiratory failure should
CPAP                                                                   be given a trial of NIV. CPAP has also been used in the
The best evidence for the efficacy of CPAP in any type of respi-        treatment of patients with severe decompensated OSA.57 58
ratory failure comes from four randomised controlled                   • Both CPAP and NIV have been used successfully in patients with
trials38–41 and a systematic review with meta-analysis42 in               decompensated obstructive sleep apnoea. Although no direct
cardiogenic pulmonary oedema.                                             comparison is available, NIV (in the form of bi-level pressure sup-
   Three trials39–41 compared CPAP with medical treatment                 port) should be used for these patients if a respiratory acidosis is
alone. Important exclusions from the trials included patients             present. [C]
unresponsive to speech or who were unable to maintain their
own airways. A number of patients were hypercapnic upon                Chest trauma
entry. A total of 180 patients were entered into the three stud-       One randomised controlled trial59 and two case series60 61 sup-
ies and primary end points were the need for intubation and            port the use of CPAP in isolated chest trauma. A trial was per-
hospital mortality. Two of the studies39 41 applied a fixed CPAP        formed on 69 patients with more than two rib fractures and
of 10 cm H2O while the third40 titrated CPAP from 2.5 to               hypoxaemia.59 CPAP and regional analgesia were compared
12.5 cm H2O. All three studies found a survival benefit with            with immediate intubation followed by intermittent positive
CPAP although individual trial 95% confidence intervals                 pressure ventilation (IPPV) with PEEP. The randomisation
included zero effect. All three also found a reduction in the          method was not described in the study and it was clearly
need for intubation with CPAP. The systematic review by Pang           impossible to blind treatment. The injury severity score was
et al42 concluded that all three trials were well conducted.           also higher in the intubated group. CPAP resulted in fewer
Pooled data showed a decreased need for intubation with                treatment days (mean 4.5 v 7.3), mean ICU days (5.3 v 9.5),
CPAP (risk difference –26%, 95% CI –13 to –38) and a trend to          and hospital days (8.4 v 14.6). Both deaths occurred in the
decreased hospital mortality (risk difference –6.6%; 95% CI 3          intubated group. It should be noted that patients with greater
to –16).                                                               than moderate lung injury, as defined by a PaO2 of <8 kPa on


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Non-invasive ventilation in acute respiratory failure                                                                                             201


an FiO2 of 40% or greater, were excluded from the study. The              with cystic fibrosis72 where invasive ventilation produces a
use of IPPV in the control group, with relatively mild gas                uniformly poor outcome. There is insufficient evidence to rec-
exchange problems, could be challenged in view of more                    ommend its routine use in these patients.
recent evidence of adverse effects associated with barotrauma.            • A trial of NIV may be undertaken in patients with a respiratory
When CPAP is used in patients with rib fractures it is impor-               acidosis (pH<7.35) secondary to an acute exacerbation of
tant to realise that there is the risk of developing a pneumot-             bronchiectasis, but excessive secretions are likely to limit its effective-
horax similar to that with invasive ventilation.                            ness and it should not be used routinely in bronchiectasis. [C]
• CPAP should be used in patients with chest wall trauma who
   remain hypoxic despite adequate regional anaesthesia and high flow      Other conditions
   oxygen. [C] NIV should not be used routinely. [D]                      Case series have reported success with NIV in a variety of
                                                                          other conditions such as adult respiratory distress
• In view of the risk of pneumothorax, patients with chest wall
                                                                          syndrome.73 Two randomised trials of NIV have included
   trauma who are treated with CPAP or NIV should be monitored on
                                                                          patients with a wide range of conditons other than COPD,
   the ICU. [D]
                                                                          although pneumonia and cardiogenic pulmonary oedema
                                                                          were the most common diagnoses in both. Wysocki et al74 ran-
Pneumonia
                                                                          domised 41 patients to NIV or conventional treatment and
Confalonieri et al62 have reported a prospective randomised
                                                                          found no difference in intubation rate, length of ICU stay, or
controlled trial of 56 consecutive patients with community
                                                                          mortality, with benefit experienced only by the subgroup with
acquired pneumonia randomised to receive conventional
                                                                          hypercapnia. In a more recent study Antonelli et al75 conducted
treatment alone or with the addition of NIV. NIV was well tol-
                                                                          a prospective randomised controlled trial of NIV against
erated, safe, and associated with a significant reduction in res-
                                                                          tracheal intubation with conventional mechanical ventilation
piratory rate, need for tracheal intubation (21% v 50%;
                                                                          in 64 patients with hypoxaemic acute respiratory failure who
p=0.03), and meaan (SD) duration of ICU stay (1.8 (0.7) days
                                                                          required mechanical ventilation. There was no statistically
v 6.0 (1.8) days; p=0.04). There was no difference in hospital
                                                                          significant difference in survival but more patients in the con-
mortality, but in the subgroup with co-existing COPD those
                                                                          ventional ventilation group had serious complications (66% v
randomised to NIV had an improved 2 month survival (88.9%
                                                                          38%, p=0.02) and had pneumonia or sinusitis related to the
v 37.5%; p=0.05).
                                                                          tracheal tube (31% v 3%, p=0.003). Among the survivors,
   CPAP has been used in the treatment of severe community
                                                                          patients in the NIV group had shorter periods of ventilation
acquired pneumonia,63 varicella pneumonia,63 and has become
                                                                          (p=0.006) and shorter stays in the ICU (p=0.002). They con-
standard treatment for the treatment of pneumocystis
                                                                          cluded that, in patients with acute respiratory failure, NIV was
pneumonia in immunosuppressed patients (particularly those
                                                                          as effective as conventional ventilation in improving gas
who are HIV positive). Numerous case series and reports64–69
                                                                          exchange and was associated with fewer serious complica-
have shown that CPAP improves oxygenation, reduces respira-
                                                                          tions and a shorter stay in the ICU.
tory rate, and lessens dyspnoea in this situation. In a
                                                                             More recently, Antonelli et al76 have reported the results of a
randomised controlled trial of CPAP in 123 patients with non-
                                                                          randomised controlled trial of NIV in solid organ transplant
hypercapnic acute respiratory failure, 51 of whom had
                                                                          recipients who developed type 1 respiratory failure. A more
pneumonia, oxygenation and dyspnoea scores were better in
                                                                          rapid improvement in oxygenation and a reduction in intuba-
the CPAP group after 1 hour; however, there were no
                                                                          tion rate was found with NIV. Hilbert et al77 have shown a
significant differences in intubation rates, mortality, or length
                                                                          reduction not only in intubation rate but also in mortality in a
of ICU stay.70 There were more adverse effects in the CPAP
                                                                          randomised controlled trial of NIV in immunosuppressed
group, including four cardiorespiratory arrests, presumably
                                                                          patients with type 1 respiratory failure.
secondary to delayed intubation.
                                                                          • NIV has been used in a variety of other conditions (such as acute
• CPAP improves oxygenation in patients with diffuse pneumonia
                                                                            respiratory distress syndrome, postoperative or post-transplantation
  who remain hypoxic despite maximum medical treatment. NIV can
                                                                            respiratory failure) with reduced intubation rates, ICU stay, and
  be used as an alternative to tracheal intubation if the patient
                                                                            mortality. In this context, patients who would be considered for
  becomes hypercapnic. [C] In this context, patients who would be
                                                                            intubation if NIV fails should only receive NIV in an ICU. [D]
  candidates for intubation if NIV fails should only received NIV in an
  ICU. [D]                                                                Weaning in the ICU
                                                                          Nava et al78 compared weaning using NIV or continued invasive
Asthma                                                                    ventilation in 50 patients who had been intubated and venti-
Meduri et al71 reported successful use of NIV in 17 episodes of           lated either from the outset or following a failed trial of NIV.
status asthmaticus. Mean pH was 7.25 (H+ 56 nmol/l)                       After 48 hours patients on invasive ventilation were subjected
confirming severe acute respiratory failure, and NIV resulted              to a 2 hour T piece trial; those who failed were randomised to
in a rapid improvement in physiological variables; only two               extubation onto a non-invasive ventilator or continued
patients required intubation. Although NIV has been used                  invasive ventilation. Similar weaning strategies were em-
successfully in patients with acute asthma, there is insuffi-              ployed in the two groups and there was a clear advantage for
cient evidence to recommend its use in this context. There is             the non-invasive approach in the percentage of patients
also insufficient evidence to recommend CPAP in acute                      successfully weaned, duration of need for assisted ventilation,
asthma.                                                                   ICU stay, survival, and incidence of ventilator associated
• NIV should not be used routinely in acute asthma. [C]                   pneumonia. This suggests a role for NIV in patients who
                                                                          initially have had to be ventilated invasively.
Cystic fibrosis/bronchiectasis                                               Girault et al79 compared NIV with continued invasive venti-
There are no randomised controlled trials of NIV versus                   lation in a randomised study on 33 patients who failed a
conventional treatment in these patient groups. Physiologi-               T-piece trial. The patients who received NIV could be extubated
cally, they are similar to patients with COPD with evidence of            earlier, but there was no difference in the number who could
severe airflow obstruction. However, in addition, secretions are           be weaned, the length of ICU stay, or survival at 3 months.
often excessive and this may limit the applicability of NIV. NIV             NIV can be used through the upper airway while a trache-
can be used as an adjunct to physiotherapy, but evidence for its          ostomy tube is in place. The tube can be capped off provided
effectiveness in clearing secretions is lacking. NIV has been             the cuff is deflated. It is sometimes not possible to achieve
used successfully as a bridge to transplantation in patients              effective ventilation with NIV despite deflating the cuff



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202                                                                                                             BTS Standards of Care Committee


                                                                              Taken together, these data suggest that NIV is more likely to
   Table 1       Factors associated with success or failure in              be successful in patients with a less severe physiological
   NIV                                                                      derangement at baseline in whom there is a rapid improve-
      Success                                     Failure                   ment in pH and respiratory rate with NIV and in whom it is
                                                                            possible to achieve a reasonable fit between the mask and the
      High PaCO2 with low A–a oxygen gradient     High APACHE score
                                                                            patient’s face. However, it is not possible at the outset to pre-
      pH 7.25–7.35 (H+ 56–45 nmol/l)              Pneumonia on chest
                                                  radiography               dict who will derive benefit from NIV.
                                                                              Factors associated with the success or failure of NIV are
      Improvement in pH, PaCO2, and respiratory   Copious respiratory
      rate after 1 hour of NIV                    secretions                shown in table 1.
      Good level of consciousness                 Edentulous
                                                  Poor nutritional status
                                                                            CONTRAINDICATIONS
                                                  Confusion or impaired     The boundaries for the use of NIV continue to expand.
                                                  consciousness             However, intubation and conventional ventilation remain the
                                                                            “gold standard” in the management of many patients with
                                                                            acute respiratory failure. Local protocols need to be developed
                                                                            in order to avoid inappropriate trials of NIV in patients who
                                                                            require urgent intubation. NIV is not appropriate in well
because there is insufficient gap between the tracheostomy                   documented end stage disease or when several co-morbidities
tube and the tracheal wall. NIV is easier with a smaller                    are present. There are no absolute contraindications although
uncuffed fenestrated tracheostomy tube in place. This can be                a number have been suggested.80 82 These include coma or con-
changed to a mini-tracheostomy tube for a few days if access                fusion, inability to protect the airway, severe acidosis at pres-
to the lower respiratory tract is still required for aspiration of          entation, significant co-morbidity, vomiting, obstructed bowel,
secretions.                                                                 haemodynamic instability (two studies have shown only small
• NIV has been used successfully to wean patients from invasive ven-        changes in cardiac output when NIV is initiated62 82 but
  tilation and should be used when conventional weaning strategies          haemodynamic collapse comparable to that often seen when
  fail. [B]                                                                 patients are intubated is seldom seen), radiological evidence
                                                                            of consolidation, and orofacial abnormalities which interfere
Predictors of outcome of NIV in acute respiratory                           with the mask/face interface. In part, these “contraindica-
failure                                                                     tions” have been determined by the fact that they were exclu-
An improvement in pH22 29 and a reduction in respiratory                    sion criteria for the controlled trials. It is therefore more cor-
rate22 after 1 hour has been shown to be associated with a                  rect to state that NIV is not proven in these circumstances
successful outcome from NIV. Soo Hoo et al80 in a small study               rather than that it is contraindicated. Other “contraindica-
(14 episodes in 12 patients), in which NIV was successful in                tions” such as failure of pH to improve within one hour82 are a
50% of cases, found that there were no differences in age,                  self-fulfilling prophecy if they have been determined from the
prior pulmonary function, baseline arterial blood gas                       outset as indicating a failure of treatment. Whether NIV is
tensions, admission arterial blood gas tensions, or respiratory             contraindicated or not must depend on individual circum-
rate between those patients successfully treated and those                  stances. For instance, if invasive ventilation is not considered
who failed NIV. Unsuccessfully treated patients had                         appropriate but NIV would be acceptable, there is nothing to
more severe illness than successfully treated patients, as                  be lost by a trial of NIV and there are no contraindications. By
indicated by a higher Acute Physiology and Chronic Health                   contrast, in an individual moribund with life threatening
Evaluation (APACHE) II score, and had pneumonia or excess                   asthma who may be very difficult to ventilate non-invasively
secretions. In addition, they were edentulous and had pursed                but in whom no problems with weaning would be anticipated,
lip breathing—factors that prevented adequate mouth seal                    there is little to be gained and much to be lost by attempting
and contributed to greater mouth leaks than in successfully                 NIV.
treated patients. Successfully treated patients were able to                   NIV has been used in patients with an undrained pneumot-
adapt more rapidly to the nasal mask and ventilator, with                   horax without apparently causing the pneumothorax to
greater and more rapid reduction in PaCO2, correction of pH,                increase in size.83 However, in most patients with a pneumot-
and reduction in respiratory rate. In a study of NIV in 17 con-             horax it will be appropriate to insert an intercostal drain
secutive patients with respiratory failure of various causes,81             before commencing NIV.
NIV was successful in 47%; patients successfully ventilated                    Contraindications to the use of NIV are listed in box 2.
with NIV had a higher PaCO2, a lower pH (7.33 (0.03) v 7.45
(0.08); p=0.02), and a lower alveolar–arterial oxygen
difference (P(A–a)O2) (144 (46) mm Hg v 265 (18) mm Hg;                      Box 2     Contraindications to NIV
p=0.01), suggesting that CO2 retention without major
hypoxaemia is a better indication for NIV than severe                        • Facial trauma/burns
                                                                             • Recent facial, upper airway, or upper gastrointestinal tract*
hypoxaemia alone. In both groups of patients gas exchange                      surgery
improved after 1 hour on NIV, but such values were                           • Fixed obstruction of the upper airway
not improved on the first day in patients who failed with                     • Inability to protect airway*
NIV.                                                                         • Life threatening hypoxaemia*
   Ambrosino et al 82 in a larger study of 59 episodes in 47                 • Haemodynamic instability*
patients of which 78% were successfully treated with NIV                     • Severe co-morbidity*
found that success was more likely with less severely                        • Impaired consciousness*
abnormal baseline clinical and functional parameters and                     • Confusion/agitation*
with less severe levels of acidosis. Pneumonia was associated                • Vomiting
                                                                             • Bowel obstruction*
with a worse outcome. However, Confalonieri et al62 in a study
                                                                             • Copious respiratory secretions*
of NIV in community acquired pneumonia found that NIV                        • Focal consolidation on chest radiograph*
reduced the tracheal intubation rate overall but only improved               • Undrained pneumothorax*
2 month survival in the subgroup with COPD. This suggests
that there is still a role for NIV in patients with radiological             *NIV may be used, despite the presence of these contraindications, if
                                                                             it is to be the “ceiling” of treatment.
consolidation.


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Non-invasive ventilation in acute respiratory failure                                                                                           203


• NIV should not be used in patients after recent facial or upper air-        be able to carry out these measurements rather than relying
  way surgery, in the presence of facial abnormalities such as burns or       on the duty doctor. Timing of arterial blood gas measure-
  trauma, if there is fixed obstruction of the upper airway, or if the         ment will depend on the patient’s condition and response to
  patient is vomiting. [D]                                                    treatment. In most studies workers have made measure-
• Contraindications to NIV include recent upper gastointestinal               ments at 0, 1 hour, 4 hours, and varying intervals thereafter.
  surgery, inability to protect the airway, copious respiratory secretions,   During the first 24 hours the use of an indwelling arterial
  life threatening hypoxaemia, severe co-morbidity, confusion/                line should be considered and this is more likely in an
  agitation, or bowel obstruction. NIV can be used in the presence of         ICU/HDU.
  these contraindications provided contingency plans for tracheal                All patients must routinely have a clinical re-assessment
  intubation have been made, or if a decision has been made not to            approximately 1 hour after being established on NIV, together
  proceed to invasive ventilation. [C]                                        with blood gas analysis. Frequency of subsequent measure-
• Although NIV has been used successfully in the presence of a pneu-          ments will depend on the patient’s progress. In cases where
  mothorax, in most patients with a pneumothorax an intercostal               the patient’s clinical condition is rapidly improving, blood
  drain should be inserted before commencing NIV. [C]                         samples should not be taken frequently as these patients are
                                                                              often sleep deprived and need to correct this. When there is no
                                                                              improvement or it is very slow, more frequent assessment
MONITORING                                                                    should be made to guide FiO2, ventilator setting, or interface
Monitoring of patients on NIV should include clinical assess-                 adjustments. A further assessment (with or without blood gas
ment combined with pulse oximetry and arterial blood gas
                                                                              analysis) should be taken within 1 hour of any change in FiO2
tensions. The actual monitoring will vary depending on the
                                                                              or ventilator setting.
location in which they receive treatment and therefore, to
                                                                                 It is important to realise that failure of improvement in
some extent, the underlying aetiology of respiratory failure,
                                                                              arterial blood gas tensions is not an indication for simply
whether the patient is a candidate for ventilation, and whether
                                                                              increasing the FiO2 but for clinical re-evaluation of the patient.
there is other co-morbidity. Patients in the ICU or HDU are
likely to be monitored according to the routines adopted in                   Any changes in oxygenation cannot be assessed in the absence
those environments.                                                           of information regarding the inspired oxygen concentration,
                                                                              and it is vital that the metered flow rate and the mode of sup-
Clinical evaluation                                                           plementation are clearly recorded.
Physiological monitoring is not a substitute for clinical assess-             • Clinical evaluation of the patient should include assessment of
ment and observation of the patient on the ventilator should                    patient comfort, conscious level, chest wall motion, accessory muscle
be made regularly. Clinical features that should be assessed                    recruitment, coordination of respiratory effort with the ventilator,
are:                                                                            respiratory rate, and heart rate. Patients receiving NIV should be
• Chest wall movement                                                           reviewed regularly to assess their response to treatment and to opti-
                                                                                mise the ventilator settings. [D]
• Coordination of respiratory effort with the ventilator
• Accessory muscle recruitment                                                • The need for arterial blood gas analysis will be governed by the
                                                                                patient’s clinical progress, but should be measured in most patients
• Heart rate                                                                    after 1–2 hours of NIV and after 4–6 hours if the earlier sample
• Respiratory rate                                                              showed little improvement. If there has been no improvement in
• Patient comfort                                                               PaCO2 and pH after this period, NIV should be discontinued and
• Mental state                                                                  invasive ventilation considered. [B]
  When initiating NIV it is important that the therapist                      • Oxygen saturation should be monitored continuously for at least 24
observes the effect of treatment in enhancing chest wall                        hours after commencing NIV and supplementary oxygen adminis-
movement. Lack of an improvement indicates that alveolar                        tered to maintain saturations between 85% and 90%. [C]
ventilation is not increasing and causes should be sought.
These include inappropriate ventilator settings leading to                    Treatment failure
patient intolerance, inadequate tidal volume or inflation pres-                Assessment and definition of treatment failure will depend on
sure, and leaks around the mask or through the open mouth.                    the role of NIV in individual patients which should be estab-
Monitoring of heart and respiratory rate is essential and can                 lished before the trial of NIV. However, factors to take into
be helpful in determining the response to treatment early on,                 account are:
before other physiological measurements are made.9 21 51 52 84–87
Improvement in breathlessness is usually seen within 1–2                      • Deterioration in patient’s condition
hours21 51 87 88 and is usually accompanied by improvement in                 • Failure to improve or deterioration in arterial blood gas ten-
the neurological state.32 74 89                                                 sions
                                                                              • Development of new symptoms or complications such as
Oxygen saturation and arterial blood gas tensions
                                                                                pneumothorax, sputum retention, nasal bridge erosion
In published studies of NIV, data on oxygen saturation or
transcutaneous CO2 have seldom been reported. However, sev-                   • Intolerance or failure of coordination with the ventilator
eral studies have shown that oxygen levels improve early with                 • Failure to alleviate symptoms
NIV21 49 85 86 88 89 and, on this basis, SpO2 monitoring is likely to         • Deteriorating conscious level
be helpful, although does not replace the need for frequent
measurements of arterial blood gas tensions in the early                      • Patient and carer wish to withdraw treatment
stages of treatment. Ideally, there should be continuous moni-                  Some of the alterations to NIV which can be made if arterial
toring of SpO2 for the first 24 hours of treatment, aiming to                  blood gases fail to improve are shown in box 3. A management
keep saturation above 85%, with supplemental oxygen if nec-                   plan of what to do if NIV fails should be made early, ideally by
essary. Transcutaneous CO2 monitoring may also be used                        a respiratory physician. Likewise, the decision to progress to
where it is available.                                                        intubation should be made by an experienced clinician in
   Arterial or arterialised capillary blood gas analysis of                   consultation with ICU staff.
pH, PaCO2. and PaO2 are critically important in the assessment                     The expected improvement in arterial blood gas tensions
of patients on NIV and, ideally, staff providing NIV should                   with NIV varies and is affected by the underlying pathology



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204                                                                                                    BTS Standards of Care Committee


                                                                   NIV (1–21 days).90 Many workers in this field believe that, in
 Box 3       Treatment failure in NIV                              the early phase of treatment (the first 24 hours or until
                                                                   improving), the patient should be ventilated for as many hours
 Is the treatment of the underlying condition optimal?             as possible as clinically indicated and can be tolerated, and this
 • Check medical treatment prescribed and that it has been         is borne out by one randomised controlled trial.21
   given                                                              Clinical improvement and stability of the patient’s condi-
 • Consider physiotherapy for sputum retention                     tion are the most important factors in determining when NIV
 Have any complications developed?                                 may be safely withdrawn. It is often recognised by patients
                                                                   who independently decide to cease use of the machine. One
 • Consider a pneumothorax, aspiration pneumonia, etc
                                                                   study indicated that the mode of weaning is to reduce periods
 Paco2 remains elevated                                            of ventilation according to clinical criteria, reducing diurnal
 • Is the patient on too much oxygen?                              ventilation before nocturnal.91 Another study has suggested a
      • Adjust FiO2 to maintain SpO2 between 85% and 90%           respiratory rate of <24 breaths/min, heart rate <110
 • Is there excessive leakage?                                     beats/min, compensated pH >7.35 (H+ <45 nmol/l), and SpO2
      • Check mask fit                                             >90% on FiO2 <4 l/min.21
      • If using nasal mask, consider chin strap or full-face      • Breaks from NIV should be made for drugs, physiotherapy, meals,
        mask                                                         etc. Patients who show benefit from NIV in the first few hours
 • Is the circuit set up correctly?                                  should be ventilated for as much as possible during the first 24
      • Check connections have been made correctly
                                                                     hours, or until improving. [B]
      • Check circuit for leaks
 • Is re-breathing occurring?
      • Check patency of expiratory valve (if fitted)              Indications for referral for domiciliary NIV
      • Consider increasing EPAP (if bi-level pressure             Most patients treated with NIV for acute respiratory failure
        support)                                                   can be weaned from ventilatory support within a few days. If
 • Is the patient synchronising with the ventilator?               NIV is still needed more than one week after the acute
      •   Observe patient                                          episode, this may be an indication that longer term NIV will be
      •   Adjust rate and/or IE ratio (with assist/control)        necessary and consideration should be given to referring the
      •   Check inspiratory trigger (if adjustable)                patient to a centre providing home NIV.
      •   Check expiratory trigger (if adjustable)                    On recovery, all patients who have been treated with NIV
      •   Consider increasing EPAP (with bi-level pressure sup-    should undergo spirometric testing and arterial blood gas
          port in COPD)                                            analysis while breathing air before discharge from hospital. In
 • Is ventilation inadequate?                                      accordance with RCP guidelines,92 if the pre-discharge arterial
      • Observe chest expansion                                    blood gas measurement shows a PaO2 of <7.3 kPa in patients
      • Increase target pressure (or IPAP) or volume               with COPD, a repeat measurement should be made after an
      • Consider increasing inspiratory time                       interval of at least 3 weeks. If hypoxaemia persists, a trial of
      • Consider increasing respiratory rate (to increase          oxygen will normally be warranted and, at this stage, noctur-
        minute ventilation)                                        nal NIV can be considered if the patient is hypercapnic while
      • Consider a different mode of ventilation/ventilator, if    breathing air or if the PaCO2 rises significantly with administra-
        available                                                  tion of sufficient supplementary oxygen to correct the hypox-
 Paco2 improves but Pao2 remains low                               aemia. It has also been suggested that long term domicilary
 • Increase FiO2                                                   NIV should be considered in patients with COPD who have
 • Consider increasing EPAP (with bi-level pressure support)       had three or more episodes of acute hypercapnic respiratory
                                                                   failure in the previous year. The role of long term nocturnal
                                                                   NIV in COPD is not yet clearly established.
                                                                      Nocturnal NIV in patients with chronic respiratory failure
and severity of respiratory decompensation. Most trials which      secondary to restrictive chest wall abnormalities is associated
describe a positive response to treatment, including ran-          with prolonged survival. Any patient with neuromuscular dis-
domised controlled trials, have noted an early improvement in      ease or chest wall deformity who has an episode of hypercap-
PaO2, pH, and PaCO2. This is usually evident at 1 hour and cer-    nic respiratory failure must be referred to a specialist unit for
tainly at 4–6 hours. Lack of progress towards correction of dis-   assessment of long term domiciliary therapy.93 Similarly,
turbance of these parameters has been associated with failure      patients with cervical cord lesions who have an episode of
of NIV.21 50 A degree of stability should be reached by 4–6        acute respiratory failure should be referred to a spinal injuries
hours.                                                             unit for assessment.
   The point at which NIV should be abandoned and the                 Many patients with respiratory failure are overweight and it
patient intubated will vary with each individual, but will         can be difficult to quantify the contribution of obesity to their
include considerations such as severity of ventilatory failure,    respiratory problems. Patients with morbid obesity (BMI >30)
likelihood of difficulty weaning from invasive ventilation, the     who develop hypercapnic respiratory failure may have a
patient’s wishes, and whether there are factors such as exces-     central respiratory drive problem or decompensated obstruc-
sive secretions which could be better managed if the patient       tive sleep apnoea, and on recovery and they should also be
was intubated. If NIV is clearly failing to palliate a patient’s
                                                                   referred for further investigation.
symptoms and they are not candidates for intubation, NIV
                                                                      Indications for referral for consideration of long term NIV
should be stopped and alternative treatment considered.
                                                                   are shown in box 4.
Withdrawal of NIV                                                  • All patients who have been treated with NIV for acute hypercapnic
The duration of NIV required is very variable. However, unlike       respiratory failure should undergo spirometric testing and arterial
IPPV, it is not mandatory or continuous even in the acute            blood gas analysis while breathing air prior to discharge. [C]
phases of treatment, with patients having periods off the ven-     • All patients with spinal cord lesions, neuromuscular disease, chest
tilator for other treatment such as nebulisers or for meals.         wall deformity, or morbid obesity who develop acute hypercapnic
Studies vary considerably in the extent of treatment in the          respiratory failure should be referred for assessment to a centre pro-
first 24 hours (4–20 hours/day) as well as the total duration of      viding long term ventilation at home. [C]


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Non-invasive ventilation in acute respiratory failure                                                                                          205


                                                                             Hence, NIV can be used in a variety of “high dependency”
 Box 4 Indications for referral for consideration of                      locations where it has been shown to be effective. Location
 long term NIV                                                            will be dependent on the degree of acidosis on arterial
                                                                          blood gas analysis, the predetermined role of NIV in
 • Failure to wean from NIV                                               individual patients, and the available cohort of staff with
 • Acute hypercapnic respiratory failure secondary to:                    experience. There should be a designated place in each hospi-
    •   Spinal cord lesion                                                tal, together with structures to ensure that patients are
    •   Neuromuscular diseases                                            transferred to this area with the minimum of delay. At
    •   Chest wall deformity (e.g. scoliosis, thoracoplasty)              present this is unlikely to be in the medical admissions unit
    •   Morbid obesity (BMI >30)                                          or accident and emergency setting. The studies vary greatly in
 • COPD with:
                                                                          time from admission to when NIV is started and there is, as
    • Recurrent AHRF (>3 episodes) requiring treatment
                                                                          yet, little evidence of benefit from starting NIV early. The
      with NIV
                                                                          exception is cardiac failure where evidence suggests that
    • Intolerance of supplementary oxygen (because of
                                                                          CPAP should be started as early as possible following the
      CO2 retention) with symptomatic sleep disturbance
                                                                          decision to use it.
                                                                          • NIV can be provided in a number of locations including the inten-
                                                                             sive care unit, a high dependency unit, or a respiratory ward. How-
USING NIV IN THE HOSPITAL SETTING                                            ever, each hospital should have a specific designated area with an
Why set up an acute NIV service?                                             available cohort of staff with appropriate experience, together with
NIV is becoming established as an important modality in the                  structures to ensure that patients requiring NIV can be transferred
management of acute respiratory failure. The skills required                 to this area with the minimum of delay. [C]
are easily learnt and the equipment required is relatively inex-          • The clinical area in which a patient is treated with NIV will
pensive. If an acute NIV service is not provided, the shortage of           be influenced by several factors including their clinical state,
ICU beds means that some patients will die because facilities               whether they will be intubated if NIV fails, and the availablility of
to ventilate them invasively are not available. Even if they are            beds. Taking into account the overall clinical picture, patients with
intubated, some patients will die unnecessarily from compli-                more severe acidosis (pH <7.30, H+ >50 nmol/l) should be man-
cations such as pneumonia which they would not have devel-                  aged in a higher dependency area such as an HDU or ICU, as
oped if they had been ventilated non-invasively. These factors              should those in whom improvement in clinical state and arterial
must be weighed against the potential disadvantages of an                   blood gas tensions is not seen after 1–2 hours of NIV on a respira-
acute NIV service, the most important of which is that severely             tory ward. [C]
ill patients might receive NIV when intubation and invasive
ventilation would be more appropriate.                                    • Patients with acute hypercapnic respiratory failure from a cause
                                                                            where the role of NIV is not yet clearly established (such as
                                                                            pneumonia, ARDS, asthma) should only receive NIV in an HDU or
Who should be responsible for the NIV service?                              ICU where facilities for immediate tracheal intubation are
There should be a named consultant who has overall respon-                  available. [C]
sibility for the acute NIV service. This will usually be a respira-
tory physician, but might also be a consultant nurse specialist
or clinical scientist. This person will have responsibility for           Who should decide to start NIV?
identifying an area where NIV is to be based, and ensuring                In most hospitals in the UK the acute take is managed by gen-
that the appropriate equipment is available and maintained.               eral physicians with a speciality interest and a respiratory
They will be responsible for the protocols used, which must be            team will not be on call each night. A simple protocol is there-
kept up to date. They must organise training for staff and                fore required to guide the on call staff as to when NIV should
ensure that audit is undertaken on a regular basis.                       be instituted (see box 5). A number of studies have used simi-
                                                                          lar guidelines.21 22 29 Regular educational sessions will be
• A named consultant should have overall responsibility for the NIV
                                                                          needed to ensure that medical staff are familiar with NIV and
  service. This will usually be a consultant respiratory physician. [D]
                                                                          with these protocols. All patients started on NIV should be
                                                                          transferred to the care of a respiratory physician as soon as
Where should this be done?                                                possible.
Prospective randomised controlled trials of the use of NIV
                                                                          • There should be a clear protocol for the on-call medical staff as to the
have shown that NIV can be set up and successfully used on
                                                                             indications for NIV, how to initiate treatment, and who has
ICU, HDU, respiratory wards, and general wards. These have
                                                                             continuing responsibility for supervision of the patient. [D]
been formal studies with funding and manpower support,
often conducted in university hospitals. Other observation
studies in district general hospitals in the UK have shown                Who should set up and maintain NIV?
successful use of NIV on a general medical and specialist res-            ICU staff, doctors, physiotherapists, lung function technicians,
piratory ward.88 The largest study in a variety of hospitals was          clinical scientists and nurses have all been reported to set up
done in Yorkshire and this showed that NIV could be used on               and maintain NIV successfully. In the 1997 UK survey setting
general and respiratory wards.30 There have been no studies               up was reported to be by nurses in 15%, physiotherapists in
comparing the efficiency of NIV between ICU, HDU, general                  9%, doctors in 33%, and a combination in 41% .94 In the largest
wards, and respiratory wards.                                             multicentre study trained nurses set up NIV in almost all hos-
   A survey of hospitals in the UK in 1997 showed that, where             pitals. There have been no studies comparing the success of
it was being used, NIV was being undertaken on a general                  any of these groups in setting up. Some studies have only used
ward in 16%, on a respiratory ward in 24%, on HDU in 12%, on              NIV during the day, but if it is to be used outside normal
ICU in 13%, and on a combination in 34%.94 There are early                working hours, nurses or physiotherapists will probably need
data suggesting that a low pH (<7.3, H+ >50 nmol/l) and a                 to be involved. Outside the ICU or HDU the on-call medical
high PaCO2 following initial resuscitation increases the rate of          staff will probably not have the time to set up NIV. A sample
failure with NIV, as does a failure of pH change at 4 hours in            protocol for setting up NIV is given in box 6 and typical initial
ward based NIV.3 It is possible that success would be improved            ventilator settings for bi-level pressure support in a patient
for these patients by more aggressive ventilation in a higher             with acute hypercapnic respiratory failure due to COPD are
dependency setting.                                                       shown in table 2.



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 Box 5      When to use non-invasive ventilation                         Box 6    How to set up non-invasive ventilation
 Patients                                                                (1) Decide about management plan if trial of NIV fails, after
 • COPD                                                                      discussion with senior medical staff, and document in the
 • Chest wall deformity, neuromuscular disorder, decompen-                   notes.
   sated OSA                                                             (2) Decide where trial of NIV should take place (ICU, HDU,
 • Cardiogenic pulmonary oedema, unresponsive to CPAP                        or respiratory ward).
                                                                         (3) Consider informing ICU.
 Blood gases                                                             (4) Explain NIV to the patient.
 • Respiratory acidosis (PaCO2 >6.0 kPa, pH <7.35 or H+                  (5) Select a mask to fit the patient and hold it in place to
   >45 nmol/l) which persists despite maximal medical treat-                 familiarise the patient.
   ment and appropriate controlled oxygen therapy (patients              (6) Set up the ventilator (see table 2).
   with pH <7.25 or H+ >56 nmol/l respond less well and                  (7) Attach pulse oximeter to patient.
   should be managed in an HDU/ICU).                                     (8) Commence NIV, holding the mask in place for the first
 • Low A–a oxygen gradient (patients with severe life                        few minutes.
   threatening hypoxaemia are more appropriately managed                 (9) Secure the mask in place with straps/headgear.
   by tracheal intubation).                                              (10) Reassess after a few minutes.
                                                                         (11) Adjust settings if necessary (see box 3).
 Clinical state                                                          (12) Add oxygen if SpO2 <85%.
 •    Sick but not moribund                                              (13) Instruct the patient how to remove the mask and how to
 •    Able to protect airway                                                   summon help.
 •    Conscious and cooperative                                          (14) Clinical assessment and check arterial blood gases at
 •    Haemodynamically stable                                                  1–2 hours.
 •    No excessive respiratory secretions                                (15) Adjust settings/oxygen if necessary.
 •    Few co-morbidities                                                 (16) Institute alternative management plan if PaCO2 and pH
                                                                               have deterioriated after 1–2 hours of NIV on optimal
 Contraindications excluded                                                    settings. If no improvement, consider continuing with NIV
 •    Facial burns/trauma/recent facial or upper airway surgery                and reassess with repeat arterial blood gas analysis
 •    Vomiting                                                                 after 4–6 hours. If no improvement in PaCO2 and pH by
 •    Fixed upper airway obstruction                                           4–6 hours, institute alternative management plan.
 •    Undrained pneumothorax
 Premorbid state
 • Potential for recovery to quality of life acceptable to the          monitoring of NIV. In deciding on the location of the NIV
   patient                                                              service, it may be advisable to start NIV in one area such as an
 • Patient’s wishes considered                                          ICU or HDU and subsequently roll it out to other wards.

                                                                        Training
  Early work suggested that NIV required extra nursing                  In 1997 NIV was available in 48% of hospitals surveyed in the
time.94 Extra time is required to set up NIV when compared              UK.94 Lack of training and finance were the major reasons why
with routine care, but maintenance of the patient on NIV does           a service had not been set up. At present there are no
not require a large amount of extra nursing or physiotherapy            recognised guidelines for the training of staff undertaking NIV
time.25 28 95 96 However, nursing numbers, especially at night,         techniques. This has the potential of leading to widespread
should reflect the number of patients on ventilators.                    variations in clinical practices across the UK. One of the diffi-
                                                                        culties in the development of guidelines is that NIV services
• Trained ICU staff, doctors, physiotherapists, lung function techni-
                                                                        may be provided by a wide range of disciplines within the
  cians, and nurses can successfully set up and maintain NIV. When
                                                                        multiprofessional care team. Each discipline has a different
  setting up an acute NIV service, it is recommended that NIV to be
                                                                        baseline knowledge so the start point of training packages will
  initiated and run by nursing staff. [C]
                                                                        vary. If training standards are to be developed to fulfil both
                                                                        local and national requirements, then the range of entry levels
SETTING UP AND RUNNING AN NIV SERVICE                                   to these programmes will need to be considered.
In setting up a NIV service the involvement of senior staff in             A training programme for the provision of an NIV service
the initial stages is crucial to success. There should be at least      should provide a combination of knowledge based learning
one member of staff who has spent time in a centre which                supported by clinical experience in the workplace. This should
already has an established service. Matters to be considered            include:
are the purchase of ventilators and disposables, identification
                                                                        • Understanding of normal respiratory anatomy and physiol-
of which staff will initiate and maintain NIV, training (see
                                                                          ogy
below), and drawing up agreed protocols for initiation and
                                                                        • Understanding of the pathophysiology of respiratory failure
                                                                        • Understanding of treatment options available to the
             Table 2 Typical initial ventilator                           relevant patient population
             settings for bi-level pressure support in                  • Awareness of signs demonstrating worsening respiratory
             a patient with acute hypercapnic                             failure
             respiratory failure due to COPD
                                                                        • Understanding of the operation, maintenance, and trouble-
              Mode              Spontaneous/timed                         shooting of NIV equipment
              EPAP              4–5 cm H2O
              IPAP              12–15 cm H2O (to be increased           • Knowledge of patient interfaces used in NIV
                                as tolerated to 20 cm H2O)              • Knowledge of selection criteria for NIV
              Triggers          Maximum sensitivity
              Back up rate      15 breaths/min                          • Ability to interpret all relevant data (saturation monitor,
              Back up I:E ratio 1:3                                       blood gas analysis, etc)
                                                                        • Ability to assess the response to NIV and act accordingly in
                                                                          treatment failure


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• Knowledge of existing literature on NIV                                – (7) Presence of peripheral oedema
• Practical experience in a centre offering an NIV service               – (8) Chest radiographic appearance at this time
• An assessment of competency                                            – (9) Prescription of oxygen
                                                                         – (10) Use of ventilatory support
The BTS website contains up to date details of courses on NIV
                                                                         – (11) Use of corticosteroids
and centres which are able to offer placements for practical
experience.                                                              – (12) FEV1
• All staff involved in an acute NIV service should receive training     – (13) Screening for LTOT
  appropriate to their baseline knowledge and role in providing the      – (14) Smoking cessation advice
  service. Training in NIV should be available for consultants in        – (15) Discharge letter to GP
  respiratory medicine and should be included in all specialist
  registrar training programmes. [C]                                   (C) For patients who received NIV
• A training programme for the provision of an NIV service should        – (16) Previous ventilatory support: invasive/non-invasive
  provide a combination of knowledge based learning supported by         – (17) Arterial blood gas analysis 1 hour after starting NIV:
  clinical experience in the workplace. [C]                                 whether done, actual values
                                                                         – (18) Arterial blood gas analysis 4–6 hours after starting
Audit
                                                                            NIV: whether done, actual values
The use of NIV in acute respiratory failure should be the sub-
ject of regular audit. This may be performed alongside other             – (19) Hours of NIV in first 24 hours
related audit activity such as the care of acute COPD                    – (20) Recorded decision on action to be taken if NIV fails?
admissions or augmented care period audit of HDU activity.               – (21) Outcome of NIV: subdivide as successful/improved
The most important issues, particularly in the early stages of              and failure/no benefit. If failure/no benefit, did the
setting up an acute NIV service, include the following:                     patient receive tracheal IPPV? Reason(s) for failure: (a)
• Is an acute NIV service available?                                        intolerance of mask, (b) secretions, (c) nasal bridge ero-
• Is NIV being used appropriately?                                          sions, (d) other (specify)
   • Are all patients in whom NIV is indicated being treated?            – (22) Outcome of admission
   • Are patients receiving NIV when they would be better                – (23) Length of stay
      managed by intubation?                                             An example of an audit form, which has been piloted in
• Is NIV being used safely?                                            several centres with an established NIV service, is given in
                                                                       appendix 2.
   • Is the monitoring of patients satisfactory?
                                                                       • The use of NIV in acute respiratory failure should be the subject of
   • Are plans for escalating treatment in the event of failure
                                                                         regular audit. In addition to collection of data on patients receiving
      being made?
                                                                         NIV, details of the number of patients admitted with acute
• Is NIV being used effectively?                                         hypercapnic respiratory failure will be required, together with the
   • Is the proportion of patients who succeed with NIV simi-            use of invasive ventilation in these patients. [D]
      lar to other hospitals?
                                                                       Infection control and equipment safety
• Are patients being referred appropriately for long term              There is no published evidence which addresses infection con-
   NIV?                                                                trol issues specifically in relation to NIV. To date there have
                                                                       been no case reports of nosocomial pneumonia associated
   In order to answer these questions, the organisation of the         with this treatment modality. Nonetheless, equipment used in
NIV service and the progress of patients receiving NIV must be         delivering NIV may be exposed to potentially infectious mate-
audited. In addition, data must be collected on all patients           rial during routine use through contact with the patient’s skin,
with acute hypercapnic respiratory failure, with more detail           mucous membranes, respiratory secretions, and blood. Hospi-
on those receiving NIV. The organisational audit might form            tal policies to reduce the likelihood of cross infection should be
part of a wider audit of respiratory services—for example, the         developed in conjunction with local infection control teams.
BTS peer review scheme. Since a large proportion of patients              While some NIV providers may opt to use single use/
treated will have COPD, background information on all                  disposable products to reduce risk of cross-contamination, the
admissions with acute hypercapnic respiratory failure might            costs involved—for example, trying several masks on each
be obtained with the BTS COPD audit tool.                              patient—are likely to be prohibitive for those intent on
   The following points could be used to provide a framework           providing a high level of service. However, items stamped for
for audit:                                                             single use should not be recycled between patients.
(A) Organisational                                                        Masks and exhalation valves licensed by the manufacturer
   – (1) Is NIV available 24 hours per day for patients with           as reusable require high level disinfection between patients.
      acute respiratory failure?                                       They should be disassembled into their component parts
                                                                       before undergoing an automated process employing a
   – (2) How is it initiated, by whom, and in which clinical
                                                                       combined washer/disinfector/drier using heat at a moderate
      areas?
                                                                       but effective temperature—for example, the Health Technical
   – (3) Who is responsible for the service?                           memorandum HTM2030 cycle which peaks at 87°C for 1
   – (4) Are there agreed guidelines for initiating NIV? What          minute. Items which are heat sensitive at this temperature
      are these? How are they disseminated?                            may be reprocessed using a cycle which reaches 71°C for 3
(B) Process and outcome of patients with acute hypercapnic             minutes. Reusable tubing is very difficult to decontaminate
respiratory failure secondary to COPD                                  effectively using this method (because of the length and
                                                                       diameter of the lumen) but can be autoclaved at 134°C for 3.5
   – (5) Performance status                                            minutes. Headgear and chinstraps should be reprocessed in a
   – (6) Arterial blood gas analysis on admission (or at time          washing machine with a cycle which reaches either 65°C for
      after admission when respiratory failure developed).             10 minutes or 71°C for 3 minutes. All reprocessed equipment
      Repeat arterial blood gas analysis within 12 hours of ini-       should be inspected for integrity prior to reuse and manufac-
      tial pH <7.35 (H+ >45 nmol/l)                                    turers’ guidelines should be followed regarding the maximum



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208                                                                                                                BTS Standards of Care Committee


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                                                                           28 Barbe F, Togores B, Rubi M, et al. Noninvasive ventilatory support does
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J Moxham, London; M Polkey, Royal College of Physicians, London;           29 Bott J, Carroll MP, Conway JH, et al. Randomised controlled trial of
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                                                                           30 Plant PK, Owen JL, Elliott MW. Early use of non-invasive ventilation for
                                                                              acute exacerbations of chronic obstructive pulmonary disease on general
Funding: Meeting rooms and travel expenses were provided by the
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Conflicts of interest: Craig Davidson has received an educational grant        ventilation improves the immediate and long-term outcome of COPD
from Breas Medical. No other conflicts of interest were declared.              patients with acute respiratory failure. Eur Respir J 1996;9:422–30.



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    pulmonary oedema: a randomized trial. Lancet 2000;356:2126–32.                 83 Haworth CS, Dodd ME, Woodcock AA, et al. Pneumothorax in adults
 53 Sharon A, Shpirer I, Kaluski E, et al. High dose intravenous                      with cystic fibrosis dependent on nasal intermittent positive pressure
    isosorbide-dinitrate is safer and better than BiPAP ventilation combined          ventilation (NIPPV): a management dilemma. Thorax 2000;55:620–2.
    with conventional reatment for severe pulmonary edema. J Am Coll               84 Ahmed A, Fenwick L, Angus RM, et al. Nasal ventilation vs doxapram in
    Cardiol 2000;36:832–7.                                                            the treatment of type II respiratory failure complicating chronic airflow
 54 Elliott MW, Steven MH, Phillips GD, et al. Non-invasive mechanical                obstruction Thorax 1992;47:858.
    ventilation for acute respiratory failure. BMJ 1990;300:358–60.                85 Brochard L, Isabey D, Piquet J, et al. Reversal of acute exacerbations of
 55 Simonds AK, Elliott MW. Outcome of domiciliary nasal intermittent                 chronic obstructive lung disease by inspiratory assistance with a face
    positive pressure ventilation in restrictive and obstructive disorders.           mask. N Engl J Med 1990;323:1523–30.
                                                                                   86 Meduri G, Fox R, Abou-Shala N, et al. Noninvasive mechanical
    Thorax 1995;50:604–9.
                                                                                      ventilation via face mask in patients with acute respiratory failure who
 56 Bott J, Baudouin SV, Moxham J. Nasal intermittent positive pressure
                                                                                      refused tracheal intubation. Crit Care Med 1994;22:1584–90.
    ventilation in the treatment of respiratory failure in obstructive sleep
                                                                                   87 Patrick W, Webster K. Noninvasive positive-pressure ventilation in acute
    apnoea. Thorax 1991;46:457–8.                                                     respiratory distress without prior chronic respiratory failure. Am J Respir
 57 Rennotte MT, Baele P, Aubert G, et al. Nasal continuous positive airway           Crit Care Med 1996;153:1005–11.
    pressure in the perioperative management of patients with obstructive          88 Conway J, Hitchcock R, Godfrey RC, et al. Nasal intermittent positive
    sleep apnea submitted to surgery. Chest 1995;107:367–74.                          pressure ventilation in acute exacerbations of chronic obstructive
 58 Shivaram U, Cash ME, Beal A. Nasal continuous positive airway                     pulmonary disease: a preliminary study. Respir Med 1993;87:387–94.
    pressure in decompensated hypercapnic respiratory failure as a                 89 Benhamou D, Girault C, Faure C, et al. Nasal mask ventilation in acute
    complication of sleep apnea. Chest 1993;104:770–4.                                respiratory failure: experience in elderly patients. Chest
 59 Bolliger CT, Van Eeden SF. Treatment of multiple rib fractures.                   1992;102:912–7.
    Randomized controlled trial comparing ventilatory with nonventilatory          90 Meyer T, Hill N. Noninvasive positive pressure ventilation to treat
    management. Chest 1990;97:943–8.                                                  respiratory failure. Ann Intern Med 1994;120:760–70.
 60 Hurst JM, DeHaven CB, Branson RD. Use of CPAP mask as the sole                 91 Brown J, D Jones, Mikelsons C, et al. Using nasal intermittent positive
    mode of ventilatory support in trauma patients with mild to moderate              pressure ventilation on a general respiratory ward. J R Coll Physicians
    respiratory insufficiency. J Trauma 1985;25:1065–8.                               Lond 1998;32:219–24.
 61 Linton DM, Potgieter PD. Conservative management of blunt chest                92 Royal College of Physicians. Oxygen therapy services guidelines.
    trauma. S Afr Med J 1982;61:917–9.                                                London: Royal College of Physicians, 2000.




                                                                                                                                          www.thoraxjnl.com
210                                                                                                                              BTS Standards of Care Committee


 93 Consensus Conference. Clinical indications for noninvasive positive                  95 Chevrolet JC, Jolliet P, Abajo B, et al. Nasal positive pressure ventilation
    pressure ventilation in chronic respiratory failure due to restrictive lung             in patients with acute respiratory failure. Chest 1991;100:775–82.
    disease, COPD, and nocturnal hypoventilation: a consensus conference                 96 Hilbert G, Gruson D, Vargas F, et al. Noninvasive ventilation for acute
                                                                                            respiratory failure. Quite low time consumption for nurses. Eur Respir J
    report. Chest 1999;116:521–34.
                                                                                            2000;16:710–16.
 94 Doherty MJ, Greenstone MA. Survey of non invasive ventilation (NIPPV)                97 Medical Devices Agency. Medical device and equipment management
    in patients with acute exacerbation of chronic obstructive pulmonary                    for hospitals and community-based organizations. MDA DB9801.
    disease (COPD) in the UK. Thorax 1998;53:863–6.                                         London: Medical Devices Agency, 1998.




APPENDIX 1: SIGN grading
      Levels of evidence
      1++ High quality meta analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias

      1+     Well conducted meta analyses, systematic reviews, or RCTs with a low risk of bias

      1−     Meta analyses, systematic reviews, or RCTs with a high risk of bias

      2++    High quality systematic reviews of case-control or cohort studies
             High quality case-control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal

      2+     Well conducted case-control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal

      2−     Case-control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal

      3      Non-analytical studies, eg case reports, case series

      4      Expert opinion

      Grades of recommendation
      A     At least one meta analysis, systematic review, or RCT rated as 1++, and directly applicable to the target population, or
             A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency
             of results

      B      A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results, or
             Extrapolated evidence from studies rated 1++ or 1+

      C      A body of evidence including studies rated as 2+, directly applicable to the target population, and demonstrating overall consistency of results, or
             Extrapolated evidence from studies rated 2++

      D      Evidence rated 3 or 4, or
             Extrapolated evidence from studies rated 2+




www.thoraxjnl.com
Non-invasive ventilation in acute respiratory failure                                                                                            211


APPENDIX 2: Audit record


                                                                   AUDIT RECORD


      Patient's name:                                                Hospital number:                          Date of admission:
      Q1        Sex   :           Male         Female                Q2           Date of Birth   :
      Q3        Diagnosis     :                                         COPD                      Chest wall/neuromuscular
                                                                        Obesity/hypoventilation   Other:
                                                                        Cardiogenic pulmonary oedema
                Respiratory failure        :                            Type 1 (hypoxaemic)            Type 2 (hypercapnic)
      Q4        Performance status         :                            Normal activity without restriction
                                                                        Strenuous activity limited, can do light work
                                                                        Limited activity but capable of self care
                                                                        Limited activity, limited self care
                                                                        Confined to bed/chair, no self care
                                                                        No record
      Q5        Focal consolidation on CXR                 :            Yes         No        No record
      Q6        Arterial/capillary blood gases                 :                          FiO2        PaO2 PaCO2 pH (or H+)
                                                                                          (% or       (kPa or (kPa or (units or
                                                                                          l/min)      mmHg) mmHg) nmol/l)
                 (i) On admission/onset of                              No record
                      respiratory failure
                 (ii) After 1-2 hours of NIV                            No record

                 (iii) After 4-6 hours of NIV                           No record

                 (iv) Pre-discharge                                     No record
      Q7        Recorded decision on action to be taken if NIV fails          :               Yes       No
      Q8        Place where NIV initiated              :                A&E               Medical admissions unit
                                                                        HDU               ICU               Respiratory ward
                                                                        General medical ward                Other:
      Q9        Outcome of NIV         :                                Success/improved
                                                                        Failure/no benefit
                                                                                Tracheal intubation             Yes        No
                                                                                Reasons for failure:
                                                                                   Intolerance of mask          Excessive secretions
                                                                                   Nasal bridge erosions        Other:
      Q10       Complications of NIV           :
      Q11       FEV1      :                                             Not done              .       litres          % predicted
      Q12       Outcome of admissions              :                   Discharged from hospital without NIV
                                                                       Discharged from hospital with home NIV
                                                                       Died – likely cause of death respiratory
                                                                       Died – likely cause of death non-respiratory
                                                                       Other:
      Q15       Length of stay     :                   days          Q16      Respiratory OPA arranged:
                                                                                                                            Yes        No




                                                                                                                                    www.thoraxjnl.com

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Non invasive vent2

  • 1. 192 BTS GUIDELINE Non-invasive ventilation in acute respiratory failure British Thoracic Society Standards of Care Committee ............................................................................................................................. Thorax 2002;57:192–211 INTRODUCTION A survey of acute admissions in Leeds has sug- Nomenclature gested that, if NIV was used in all patients with Non-invasive ventilation (NIV) refers to the chronic obstructive pulmonary disease (COPD) provision of ventilatory support through the with a pH of <7.35 (H+ >45 nmol/l) after initial patient’s upper airway using a mask or similar medical treatment, a typical district general device. This technique is distinguished from those hospital serving a population of 250 000 would which bypass the upper airway with a tracheal expect to treat around 70 patients per year.3 tube, laryngeal mask, or tracheostomy and are • Non-invasive ventilation has been shown to be an therefore considered invasive. In this document effective treatment for acute hypercapnic respiratory NIV refers to non-invasive positive pressure failure, particularly in chronic obstructive pulmo- ventilation, and other less commonly used tech- nary disease. Facilities for NIV should be available 24 niques such as external negative pressure or hours per day in all hospitals likely to admit such rocking beds will not be discussed. (NIPPV is an patients. [A] alternative abbreviation but it is more cumber- some and involves ambiguity as to whether “N” is NIV is not suitable for all patients with respira- for “non-invasive” or “nasal”.) tory failure. If used indiscriminately, patients who Continuous positive airway pressure (CPAP) in would be managed more appropriately by tra- this document refers to the non-invasive applica- cheal intubation will receive suboptimal treat- tion of positive airway pressure, again using a face ment. Use of NIV in patients in whom it is or nasal mask rather than in conjunction with unlikely to be beneficial is also undesirable. It is invasive techniques. Although it might be open to essential that NIV is applied in an appropriate debate as to whether the use of non-invasive clinical area by appropriately trained staff using CPAP in acute respiratory failure constitutes ven- the optimal ventilator mode, settings, and inter- tilatory support, it is included in this document face for that patient with adequate monitoring. because of the confusion which commonly arises between NIV and CPAP in clinical practice. • NIV should not be used as a substitute for tracheal intubation and invasive ventilation when the latter is Background clearly more appropriate. [B] One of the first descriptions of the use of NIV using nasal masks was for the treatment of hypoventila- Purpose of this document tion at night in patients with neuromuscular The main aims of this document are to: disease.1 2 This has proved to be so successful that it • Set standards of care for patients receiving NIV has become widely accepted as the standard in acute respiratory failure based on the avail- method of non-invasive ventilation used in pa- able evidence and define minimum standards tients with chronic hypercapnic respiratory failure for the provision of an acute NIV service caused by chest wall deformity, neuromuscular disease, or impaired central respiratory drive. It has • Identify which patients with acute respiratory largely replaced other modalities such as external failure should be considered for NIV or CPAP negative pressure ventilation and rocking beds. • Describe the optimal application of different Within a few years of its introduction, NIV was ventilatory modes and patient interfaces starting to be used in acute hypercapnic respira- tory failure and in patients with abnormal lungs rather than an impaired respiratory pump. Initial ................................................. anecdotal reports were followed by larger series Abbreviations: AHRF, acute hypercapnic respiratory Members of BTS and then by randomised trials. Analysis of these failure; ARDS, acute respiratory distress syndrome; ASB, Standards of Care trials has shown that NIV is a valuable treatment assisted spontaneous breathing; BMI, body mass index; Committee: S Baudouin, for acute hypercapnic respiratory failure, as will CMV, continuous mandatory ventilation; COPD, chronic S Blumenthal, B Cooper, be discussed under the section on Indications. It obstructive pulmonary disease; CPAP, continuous positive C Davidson, A Davison, airways pressure ; EPAP, expiratory positive airways has a number of potential advantages, particu- M Elliott, W Kinnear pressure; FiO2, fractionated inspired oxygen concentration; (Chairman), R Paton, larly the avoidance of tracheal intubation with its FRC, functional residual capacity; HDU, high dependency E Sawicka, L Turner associated mortality and morbidity from prob- unit; ICU, intensive care unit; IE, inspiratory/expiratory; (Secretary) lems such as pneumonia. Pressure on intensive IPAP, inspiratory positive airways pressure; IPPV, ....................... care unit beds is often high, and NIV can be used intermittent positive pressure ventilation; LTOT, long term Correspondence to: in other clinical areas and also at an earlier stage oxygen therapy; NIV, non-invasive ventilation; OSA, Dr W Kinnear, University than tracheal intubation. Intermittent ventilatory obstructive sleep apnoea; PaCO2, partial pressure of Hospital, Queen’s Medical assistance is possible with NIV, allowing gradual arterial carbon dioxide; PaO2, partial pressure of arterial Centre, Nottingham oxygen; PAV, proportional assist ventilation; PEEP, positive weaning and also normal eating, drinking, and end expiratory pressure; PEEPi, intrinsic PEEP; PS, pressure NG7 2UH, UK; William.Kinnear@ communication. Breaks from ventilatory support support; SpO2, oxygen saturation; SIMV, synchronised mail.qmcuh-tr.trent.nhs.uk can be used for giving nebulised medication, intermittent mandatory ventilation; S/T, ....................... physiotherapy, and expectoration. spontaneous/timed; V/Q, ventilation perfusion. www.thoraxjnl.com
  • 2. Non-invasive ventilation in acute respiratory failure 193 acute, acute-on-chronic, or chronic. Although not always Key points clearcut, this distinction is important in deciding on the loca- tion of patient treatment and the most appropriate treatment • Non-invasive ventilation (NIV) works – an evidence-based verdict strategy, particularly in type 2 respiratory failure: • NIV can be used in any hospital given the following mini- • Acute hypercapnic respiratory failure: the patient will have mum facilities: no, or minor, evidence of pre-existing respiratory disease • A consultant committed to developing an NIV service and arterial blood gas tensions will show a high PaCO2, low • Nurses on a respiratory ward, high dependency unit, pH, and normal bicarbonate. or intensive care unit who are keen to be involved in NIV • Chronic hypercapnic respiratory failure: evidence of chronic • An intensive care unit to provide back up for patients respiratory disease, high PaCO2, normal pH, high bicarbo- who do not improve on NIV nate. • A non-invasive ventilator and a selection of masks • Acute-on-chronic hypercapnic respiratory failure: an acute • NIV is particularly indicated in: deterioration in an individual with significant pre-existing • COPD with a respiratory acidosis pH 7.25–7.35 (H+ hypercapnic respiratory failure, high PaCO2, low pH, high 45–56 nmol/l) bicarbonate. • Hypercapnic respiratory failure secondary to chest Knowledge of arterial blood gases is essential before wall deformity (scoliosis, thoracoplasty) or neuro- making a decision as to whether NIV is indicated. The patient muscular diseases should first be established on appropriate oxygen therapy and • Cardiogenic pulmonary oedema unresponsive to the arterial blood gases interpreted in light of the FiO2. A pro- CPAP portion of patients who fulfil arterial blood gas criteria for NIV • Weaning from tracheal intubation • NIV is not indicated in: (see below) at the time of admission to hospital improve rap- • Impaired consciousness idly with initial medical treatment with an appropriate FiO2.3 It • Severe hypoxaemia will usually then be necessary to repeat measurement of arte- • Patients with copious respiratory secretions rial blood gas tensions to see if NIV is still needed. • The benefits of an acute NIV service are likely to be: Measurement of arterial blood gas tensions should be con- • Fewer patients referred to intensive care for sidered in all individuals with breathlessness of sufficient intubation severity to warrant admission to hospital. In certain sub- • Shorter stays on intensive care groups of patients—for example, asthmatic patients with no • Fewer deaths of patients with acute respiratory failure features of a severe attack—oxygen saturation can be used as • Visit the BTS and ARTP websites (brit-thoracic.org.uk and an initial screen, proceeding to arterial blood gas analysis in artp.org.uk) for: those with a SpO2 of <92%. However, it is important to note • The BTS recommendations on NIV that oximetry alone may provide false reassurance in patients • An up to date list of non-invasive ventilators on supplemental oxygen in whom oxygenation is well • Suppliers of equipment for NIV maintained in the face of dangerous hypercapnia. • Details of courses and centres offering training in NIV It should also be appreciated that there is a subgroup of patients with acute-on-chronic hypercapnic respiratory failure who have few symptoms despite severely deranged arterial • Define minimal monitoring requirements and give guid- blood gas tensions. In certain patients, particularly those with ance on what to do in the event of treatment failure chest wall deformity or neuromuscular disease, breathlessness may not be a prominent symptom because exercise is limited • Identify which patients should be referred for long term by other factors; there should be a low threshold for perform- NIV after initial treatment of their acute respiratory failure ing arterial blood gas measurements in patients with these • Provide guidance on setting up and running a NIV service diseases who complain of morning headaches, excessive day- including location, staffing levels, provision and mainte- time sleepiness, general tiredness, malaise, or ankle oedema. nance of equipment, minimisation of cross infection, and Respiratory failure may occasionally present as confusion, training delirium or dementia, and arterial blood gas tensions should • Facilitate collection of data on the use of NIV in acute respi- always be considered in such patients. ratory failure and provide tools for audit • The beneficial effects of NIV have mainly been demonstrated in • Identify areas requiring further research patients with a respiratory acidosis (pH <7.35 (H+ >45 nmol/l)). Knowledge of arterial blood gas tensions is therefore critical to its This document is aimed at those who wish to set up an application. Arterial blood gas tensions should be measured in most acute NIV service. It is also intended to help those who are patients with acute breathlessness. [B] seeking to expand or consolidate existing facilities, particu- • Arterial blood gas tensions improve rapidly in many patients with larly where purchasers require evidence of efficacy. The provi- acute hypercapnic respiratory failure when they receive maximum sion of long term NIV at home is not covered. NIV can be used medical treatment and appropriate supplementary oxygen. A repeat as a treatment for breathlessness in the terminal stages of sample should usually be taken after a short interval to see if NIV is progressive neuromuscular disease, but this and other special- still indicated. [B] ised applications will not be discussed further. Although NIV is being introduced into paediatric practice, the published evi- • There should be a low threshold for measuring arterial blood gas dence is not yet strong enough for recommendations to be tensions in patients with neuromuscular diseases, chest wall made about its use in children. deformity, obesity, or acute confusional states who may be in respi- ratory failure without significant breathlessness. [B] Definitions Critical care facilities are in the process of being redefined, Respiratory failure is defined as a failure to maintain adequate with dependency levels ranging from 0–3.4 However, for the gas exchange and is characterised by abnormalities of arterial purpose of this document, a high dependency unit (HDU) is blood gas tensions. Type 1 failure is defined by a PaO2 of <8 kPa defined as a clinical area staffed by appropriately trained with a normal or low PaCO2. Type 2 failure is defined by a PaO2 of nurses at a level higher than that of a general ward, usually <8 kPa and a PaCO2 of >6 kPa. Respiratory failure can be one member of staff for every two patients (level 2 care). An www.thoraxjnl.com
  • 3. 194 BTS Standards of Care Committee SUMMARY OF RECOMMENDATIONS Introduction • NIV has been shown to be an effective treatment for acute hypercapnic respiratory failure (AHRF), particularly in chronic obstructive pulmonary disease (COPD). Facilities for NIV should be available 24 hours per day in all hospitals likely to admit such patients. [A] • NIV should not be used as a substitute for tracheal intubation and invasive ventilation when the latter is clearly more appro- priate. [B] • The beneficial effects of NIV have mainly been demonstrated in patients with a respiratory acidosis (pH <7.35, H+ >45 nmol/l). Knowledge of arterial blood gas tensions is therefore critical to its application. Arterial blood gas tensions should be measured in most patients with acute breathlessness. [B] • Arterial blood gas tensions improve rapidly in many patients with AHRF when they receive maximum medical treatment and appropriate supplementary oxygen. A repeat sample should usually be taken after a short interval to see if NIV is still indi- cated. [B] • There should be a low threshold for measuring arterial blood gas tensions in patients with neuromuscular diseases, chest wall deformity, obesity, or acute confusional states who may be in respiratory failure without significant breathlessness. [B] Ventilators • Many different types of ventilator have been used successfully to provide NIV in AHRF; local expertise will influence the choice of ventilator used. If possible, a single model of ventilator should be used in any one clinical area for ease of train- ing and familiarity of staff with the equipment. [D] • Bi-level pressure support ventilators are simpler to use, cheaper, and more flexible than other types of ventilator currently available; they have been used in the majority of randomised controlled trials of NIV and are recommended when setting up an acute NIV service. [C] • Volume controlled ventilators should be available in units wishing to provide a comprehensive acute NIV service. [C] Interfaces • A selection of different sizes of nasal masks, full-face masks, and nasal pillows should be available for NIV. [C] • Both nasal and full-face masks have been used successfully for NIV in AHRF. In the acute setting, a full-face mask should be used initially, changing to a nasal mask after 24 hours as the patient improves. [D] Indications • NIV may be undertaken as a therapeutic trial with a view to tracheal intubation if it fails, or as the ceiling of treatment in patients who are not candidates for intubation. A decision about tracheal intubation should be made before commencing NIV in every patient. This should be verified as soon as possible with senior medical staff and documented in the case notes. [D] • NIV should be considered in patients with an acute exacerbation of COPD in whom a respiratory acidosis (pH <7.35, H+ >45 nmol/l) persists despite maximum medical treatment on controlled oxygen therapy. [A] • Continuous positive airway pressure (CPAP) has been shown to be effective in patients with cardiogenic pulmonary oedema who remain hypoxic despite maximal medical treatment. NIV should be reserved for patients in whom CPAP is unsuccess- ful. [B] • NIV is indicated in acute or acute-on-chronic hypercapnic respiratory failure due to chest wall deformity or neuromuscular disease. [C] • Both CPAP and NIV have been used successfully in patients with decompensated obstructive sleep apnoea. Although no direct comparison is available, NIV (in the form of bi-level pressure support) should be used for these patients if a respira- tory acidosis is present. [C] • CPAP should be used in patients with chest wall trauma who remain hypoxic despite adequate regional anaesthesia and high flow oxygen. [C] NIV should not be used routinely. [D] • In view of the risk of pneumothorax, patients with chest wall trauma who are treated with CPAP or NIV should be moni- tored on the ICU. [D] • Many patients with acute pneumonia and hypoxaemia resistant to high flow oxygen will require intubation. In this context, trials of CPAP or NIV should only occur in HDU or ICU settings. [D] • CPAP improves oxygenation in patients with diffuse pneumonia who remain hypoxic despite maximum medical treatment. NIV can be used as an alternative to tracheal intubation if the patient becomes hypercapnic. [C] In this context, patients who would be candidates for intubation if NIV fails should only received NIV in an ICU. [D] • NIV should not be used routinely in acute asthma. [C] • A trial of NIV may be undertaken in patients with a respiratory acidosis (pH <7.35, H+ >45 nmol/l) secondary to an acute exacerbation of bronchiectasis, but excessive secretions are likely to limit its effectiveness and it should not be used routinely in bronchiectasis. [C] • NIV has been used in a variety of other conditions (such as acute respiratory distress syndrome, postoperative and post- transplantation respiratory failure) with reduced intubation rates, ICU stay and mortality. In this context, patients who would be considered for intubation if NIV fails should only receive NIV in ICU. [D] • NIV has been used successfully to wean patients from invasive ventilation, and should be used when conventional wean- ing strategies fail. [B] www.thoraxjnl.com
  • 4. Non-invasive ventilation in acute respiratory failure 195 SUMMARY OF RECOMMENDATIONS (Continued) Contraindications • NIV should not be used in patients after recent facial or upper airway surgery, in the presence of facial abnormalities such as burns or trauma, if there is fixed obstruction of the upper airway, or if the patient is vomiting. [D] • Contraindications to NIV include recent upper gastrointestinal surgery, inability to protect the airway, copious respiratory secretions, life threatening hypoxaemia, severe co-morbidity, confusion/agitation, or bowel obstruction. NIV can be used in the presence of these contraindications provided contingency plans for tracheal intubation have been made, or if a deci- sion has been made not to proceed to invasive ventilation. [C] • Although NIV has been used successfully in the presence of a pneumothorax, in most patients with a pneumothorax an intercostal drain should be inserted before commencing NIV. [C] Monitoring • Clinical evaluation of the patient should include assessment of patient comfort, conscious level, chest wall motion, acces- sory muscle recruitment, coordination of respiratory effort with the ventilator, respiratory rate and heart rate. Patients receiving NIV should be reviewed regularly to assess their response to treatment and to optimise the ventilator settings. [D] • The need for arterial blood gas analysis will be governed by the patient’s clinical progress but should be measured in most patients after 1–2 hours of NIV and after 4–6 hours if the earlier sample showed little improvement. If there has been no improvement in PaCO2 and pH after this period, despite optimal ventilator settings, NIV should be discontinued and inva- sive ventilation considered. [B] • Oxygen saturation should be monitored continuously for at least 24 hours after commencing NIV and supplementary oxy- gen administered to maintain saturations between 85% and 90%. [C] • Breaks from NIV should be made for drugs, physiotherapy, meals, etc. Patients who show benefit from NIV in the first few hours should be ventilated for as much as possible during the first 24 hours, or until improving. [B] • All patients who have been treated with NIV for AHRF should undergo spirometric testing and arterial blood gas analysis while breathing air before discharge. [C] • All patients with spinal cord lesions, neuromuscular disease, chest wall deformity, or morbid obesity who develop AHRF should be referred for assessment to a centre providing long term ventilation at home. [C] Setting up an acute NIV service • A named consultant with appropriate training should have overall responsibility for the NIV service. This will usually be a consultant respiratory physician. [D] • NIV can be provided in a number of locations including the ICU, a high dependency unit (HDU), or a respiratory ward. However, each hospital should have a specific designated area with an available cohort of staff with appropriate experi- ence, together with structures to ensure that patients requiring NIV can be transferred to this area with the minimum of delay. [C] • The clinical area in which a patient is treated with NIV will be influenced by several factors including their clinical state, whether they will be intubated if NIV fails, and the availability of beds. Taking into account the overall clinical picture, patients with more severe acidosis (pH <7.30, H+ >50 nmol/l) should be managed in a higher dependency area such as an HDU or ICU, as should those in whom improvement in clinical state and arterial blood gas tensions is not seen after 1–2 hours of NIV on a respiratory ward. [C] • Patients with AHRF from a cause where the role of NIV is not yet clearly established (such as pneumonia, ARDS, asthma) should only receive NIV in an HDU or ICU where facilities for immediate tracheal intubation are available. [C] • There should be a clear protocol for the on-call medical staff as to the indications for NIV, how to initiate treatment, and who has continuing responsibility for supervision of the patient. [D] • Trained ICU staff, doctors, physiotherapists, lung function technicians, and nurses can successfully set up and maintain NIV. When setting up an acute NIV service, it is recommended that NIV be initiated and run by nursing staff. [C] • All staff involved in an acute NIV service should receive training appropriate to their baseline knowledge and role in pro- viding the service. Training in NIV should be available for consultants in respiratory medicine and should be included in all specialist registrar training programmes. [D] • A training programme for the provision of an NIV service should provide a combination of knowledge based learning sup- ported by clinical experience in the workplace. [D] • The use of NIV in acute respiratory failure should be the subject of regular audit. In addition to collection of data on patients receiving NIV, details of the number of patients admitted with acute hypercapnic respiratory failure will be required, together with the use of invasive ventilation in these patients. [D] Infection control and equipment safety • Reusable masks and exhalation valves should be reprocessed in an automated washer/disinfector/drier machine after dis- assembly into their component parts. [C] • A bacterial filter should be attached to the ventilator outlet during NIV and the external surface of the ventilator cleaned between patients. [C] • Maintenance and electrical safety checks on ventilators should be undertaken according to the manufacturers’ recommen- dations, and at least annually. [D] www.thoraxjnl.com
  • 5. 196 BTS Standards of Care Committee intensive care unit (ICU) is defined as a unit with facilities for of the lungs and chest wall. In volume control, tidal volume is the management of the intubated patient, usually with a set and the resulting pressure required to deliver this volume nurse:patient ratio of 1:1 (level 3 care). A general respiratory is determined by circuit compliance and thoracic mechanics. ward is defined as a ward admitting unselected medical, but On NIV machines CMV may be referred to as timed ventilation mainly respiratory, patients. (T). Some ventilators allow the rise time to be ramped from a slow to a rapid increase. This facility is provided for patient Methodology comfort. The ventilator may, however, fail to reach the target The Standards of Care Committee of the British Thoracic pressure when the inspiratory period is short and a prolonged Society (BTS) selected the topic as the subject for preparation rise time is selected, resulting in a smaller tidal volume. of a guideline and a subcommittee was convened. This was a multidisciplinary group including clinical experts, medical, Assist/control ventilation nursing, physiotherapy, and lung function staff. Every In assist/control mode (ACV) a preset number of mandatory subcommittee member completed a form declaring any breaths per minute will be delivered in the absence of patient potential conflicts of interest; these forms were held at the effort. As with CMV, ventilator delivered breaths are deter- BTS offices and were tabled at meetings of the subcommittee. mined by setting volume or pressure and the inspiration and A literature search was conducted on Medline, Embase and expiration durations. Patient triggering is permitted but the the Cochrane database covering 1966–2000, and further machine delivers an identical breath to mandatory breaths. To papers were obtained from the resulting reference lists and avoid excessive inflation through breath stacking, the ventila- from the personal collections of members of the subcommit- tor is programmed to fail to deliver within a variable “lock tee. Keywords used were “non-invasive ventilation”, “me- out” period. As respiratory rate is increased, the lock out chanical ventilation”, “positive pressure ventilation”, “non- period must shorten. On some ventilators, setting a long invasive positive pressure ventilation”, “nasal intermittent expiratory time also sets a long lock out and may lead to poor positive pressure ventilation”, “bi-level positive airway pres- patient tolerance. Triggered breaths delay the next machine sure”, “pressure-controlled ventilation”, “volume-controlled determined breath so that there is said to be synchronisation ventilation”, “ventilatory support”, “continuous positive air- between patient triggered and machine delivered breaths way pressure”, and “CPAP”. Searches were limited to human (SIMV). This mode is sometimes referred to as spontaneous/ studies and English language. timed (S/T) or IE mode on NIV machines. All abstracts were reviewed and articles were selected for Assisted spontaneous breathing (pressure support) inclusion on the basis of containing original patient data on In assisted spontaneous breathing (ASB) the patient’s the use of NIV or CPAP in adults with acute respiratory failure. respiratory effort triggers the ventilator both on and off. Res- Evidence tables were constructed and the recommendations piratory frequency and the timing of each breath are therefore were graded by at least two members of the subcommittee determined by the patient. As this mode usually involves set- according to the 2000 version of the Scottish Intercollegiate ting pressure, it is often termed pressure support (PS). If the Guideleine Network (SIGN) criteria (appendix 1). After the patient fails to make respiratory effort, no respiratory members had prepared their sections of this document, it was assistance will occur, although many manufactures now reviewed at two whole day meetings of the subcommittee and incorporate a back up rate of 6–8 breaths per minute. the grading for each recommendation was agreed. Further expert opinions were obtained (listed at the end of the docu- Continuous positive airway pressure ment) and, after revision, the recommendations were pre- CPAP is employed in patients with acute respiratory failure to sented to a national meeting of the BTS. A draft of the guide- correct hypoxaemia. It permits a higher inspired oxygen con- line was available on the BTS website for a period of 3 months tent than other methods of oxygen supplementation, in- for comment. The guidelines were reviewed by the members of creases mean airway pressure, and will improve ventilation to the Standards of Care Committee, the Clinical Effectiveness collapsed areas of the lung. The recruitment of underventi- and Evaluation Unit of the Royal College of Physicians of Lon- lated lung is similar to the use of positive end expiratory pres- don, the Intensive Care Society, the Faculty of Accident and sure (PEEP) in the intubated mechanically ventilated patient. Emergency Medicine, the UK Home Mechanical Ventilation CPAP also unloads the inspiratory muscles and thereby Providers Group, and the Association of Respiratory Techni- reduces inspiratory work, although in hyperinflated patients cians and Physiologists. with airflow obstruction any further increase in lung volume Further editorial changes were made in the light of produced by CPAP may have an adverse effect on the function comments received during the above process and from of the inspiratory muscles. In cases of respiratory failure due reviewers for Thorax; editorial control remained independent to exacerbations of COPD, the offsetting of intrinsic PEEP by of all sources of funding for the guideline. The guideline group CPAP (see below) may reduce ventilatory work resulting in a will be reconvened every 2 years to update the document and slowing of respiratory rate, an increase in alveolar ventilation, an updated version will be available on the BTS website (brit- and a fall in PaCO2. Although this might be considered the thoracic.org.uk). result of respiratory assistance, conventionally CPAP is not considered respiratory support and its main indication is to MODES OF NON-INVASIVE VENTILATION correct hypoxaemia. The terminology used to describe different modes of NIV can Flow generators employed in CPAP need to be capable of be confusing. The following section describes the principal maintaining the desired pressure throughout the respiratory modes. There is no standardisation between manufacturers, cycle. In domiciliary practice, as in the treatment of and unfortunately each mode may be called by different obstructive sleep apnoea (OSA), generators capable of low names on different ventilators. flows are sufficient as minute ventilation and peak inspiratory flow are low. In the distressed COPD patient the increased Controlled mechanical ventilation minute ventilation, high frequency, and short inspiratory time In the mandatory controlled mechanical ventilation (CMV) may result in peak inspiratory flow rates in excess of 60 l/min. mode, full ventilatory support is provided and no patient effort High flows are therefore required to prevent a fall in applied is required. Inflation pressure or tidal volume is set, as is fre- pressure. Some of the newer non-invasive ventilators have a quency and the timing of each breath. In pressure control, the CPAP mode capable of delivering adequate flow rates. Other resulting tidal volume depends upon the resistance to flow of CPAP generators require a high pressure oxygen supply. Whis- ventilator tubing, any airflow limitation, and the compliance per flow systems entrain room air by the Venturi effect and www.thoraxjnl.com
  • 6. Non-invasive ventilation in acute respiratory failure 197 have a FiO2 adjustable above a minimum 40%. The Draeger timed mode as the glottic aperture will not be in phase with system provides for a lower FiO2 as air and oxygen is mechanical breaths,11 12 is probably only of relevance to domi- independently set. A reservoir prevents a fall in mask pressure ciliary practice. during inspiration. CPAP masks are usually pressurised by inserting a one way exhalation valve. Pressure assist-control ventilators Technical developments such as microprocessor controlled Bi-level pressure support valves have led to most NIV ventilators now being pressure In NIV, pressure support and CPAP are often used in combina- controlled flow generators. Smith and Shneerson carried out a tion as bi-level pressure support. Ventilation is produced by bench comparison of ventilators and showed the expected the inspiratory positive airway pressure (IPAP), while the better leak compensation of pressure control.13 The de- expiratory positive airway pressure (EPAP) recruits underven- accelerating flow profile of a pressure controlled breath may tilated lung and offsets intrinsic PEEP (with beneficial effects result in better distribution of ventilation while, in the ICU, on triggering). The EPAP also serves to vent exhaled gas recognition of subtle forms of ventilator associated lung dam- through the exhaust port (see below). age has resulted in a move to pressure limited small volume ventilation. This is typified by the recruiting “permissive” Proportional assist ventilation hypercapnia ventilation strategies now recommended in acute Proportional assist ventilation (PAV) is an alternative tech- lung injury.14 nique in which both flow—to counter resistance—and Bi-level assisted spontaneous breathing ventilators volume—to counter compliance—are independently adjusted. Ventilators used for non-invasive assisted spontaneous breath- It may improve patient comfort and so improve success and ing (pressure support) usually use two different pressures: compliance with acute NIV.5 inspiratory positive airway pressure (IPAP) to assist inspira- tion, and a lower expiratory positive airway pressure (EPAP). As with other pressure controlled ventilators, compensation is NON-INVASIVE VENTILATORS made for air leakage. EPAP eliminates exhaled air through the Ventilators employed in NIV range from ICU ventilators with expiratory port, thus reducing re-breathing, encourages lung full monitoring and alarm systems normally employed in the recruitment, and stents open the upper airway. Most recent intubated patient, to light weight, free standing devices with randomised controlled trials of NIV in AHRF have used this limited alarm systems specifically designed for non-invasive mode of ventilation. One study in patients with acute COPD respiratory support. Life support ICU ventilators separate the failed to demonstrate significant benefit with bi-level over inspiratory and expiratory gas mixtures. This prevents pressure support15 while, in patients with stable neuromusc- rebreathing and allows monitoring of inspiratory pressure and ular disease, the addition of PEEP to PS increased overnight exhaled minute ventilation on which monitoring and alarm oxygenation.16 Appendini et al also found greater reduction in limits are based. In NIV single tubing is usually employed, and work of breathing with the addition of PEEP in acute COPD.17 exhalation is either active (the ventilator opens an exhalation In patients with COPD, EPAP overcomes the effects of intrin- valve—for example, NIPPY 1 or Breas PV 401) or passive sic PEEP (see below). The significant re-breathing potential of (exhaled air is encouraged to exit an exhaust valve or port by these ventilators has been reported, only eliminated by exces- continuous bias flow (EPAP) from the ventilator). Exhalation sively high expiratory pressure (EPAP). Machines were also valves may increase work of breathing, and normally used variable in their speed of response and in the time to reach set EPAP levels (3–5 cm H2O) do not completely eliminate pressure.6 rebreathing during bi-level pressure support, especially when respiratory frequency increases.6 This therefore needs to be • Many different types of ventilator have been used successfully to pro- considered in the tachypnoeic anxious individual who fails to vide NIV in AHRF; local expertise will influence the choice of venti- improve or develops worsening hypercapnia. It is important lator used. If possible, a single model of ventilator should be used in that exhalation ports or valves are fitted and functioning any one clinical area for ease of training and familiarity of staff with properly. Occlusion of the exhaust port—for instance, by the equipment. [D] sputum—can exacerbate hypercapnia through rebreathing.7 • Bi-level pressure support ventilators are simpler to use, cheaper, and more flexible than other types of ventilator currently available; they Volume assist-control ventilators have been used in the majority of randomised controlled trials of Volume controlled ventilators predominated in the past but NIV and are recommended when setting up an acute NIV service. have largely been replaced by pressure devices. Some air leak [C] is invariable with NIV, either from the mask or through the • Volume controlled ventilators should be available in units wishing to mouth, and with a volume controlled ventilator tidal volumes provide a comprehensive acute NIV service. [C] must be arbitrarily increased to compensate for this. Volume and pressure control modes have both been shown to be Triggering effective in COPD but few comparative studies have been Ventilator triggering is critical to the success of NIV in both reported. Vittaca et al8 found no difference in outcome whether spontaneous and assist/control modes.18 It is a complex field volume or pressure ventilators were used in AHRF. Girault et al and involves both sensing inspiratory effort as well as found greater respiratory muscle rest with volume assist, but determining the end of inspiration. In assist/control mode, at the cost of greater patient discomfort compared with PS.9 inspiratory support is given for a predetermined set period— The addition of PEEP to PS was not investigated, however, for instance, a pressure setting of 20 cm H2O for 1.2 seconds which might have reduced work of breathing. Some experts (Nippy 1 and 2, Sullivan VPAP). On other machines the sens- would wish to use a volume ventilator for the more difficult ing of the end of inspiration may be varied by setting the ven- patient and Schoenhofer et al reported that some patients tilator to switch to expiration at 20–80% of the maximum failed to be managed with pressure timed support but were inspiratory flow (Breas PV 401, Puritan Bennett). In others the successfully treated by volume control.10 One explanation triggers are preset by the manufacturer (Respironics BiPAP) or might be that volume control is better at ensuring alveolar only the inspiratory trigger is adjustable. Trigger sensitivity ventilation when compliance or airway resistance changes. and ventilator response times are generally good with NIV This is probably not important in acute NIV as patient moni- machines,19 although some ventilators tested showed poor toring would detect failure to correct hypercapnia. Similarly, trigger sensitivity when simulated inspiratory effort was glottic narrowing, which may limit the effectiveness of the small. www.thoraxjnl.com
  • 7. 198 BTS Standards of Care Committee Bi-level ventilators employ flow sensors which detect a change in the machine produced bias flow. Improved patient Box 1 Features of a ventilator suitable for NIV in comfort probably explains the widespread adoption of bi-level hospital ventilators. Patient-ventilator asynchrony may still result from Essential undetected inspiratory effort, a delay in response to the start • Pressure controlled of inspiration or in the detection of the end of a breath, espe- • Pressure capability of at least 30 cm H2O cially in the presence of excessive leakage.9 11 17 20 These differ- • Capable of supporting inspiratory flows of at least 60 l/min ent causes may be difficult to resolve. An alternative is to • Assist-control and bi-level pressure support modes employ the timed or ACV mode which may be set up to provide • Rate capability of at least 40 breaths/min mandatory breaths similar to the patient’s unsupported venti- • Sensitive flow triggers latory pattern. The timed mode is particularly important in • Disconnection alarm patients with advanced acute respiratory failure who may Desirable cease making spontaneous effort when “captured”, or in • Short pressure rise time capability patients who are normally dependent on hypoxic respiratory • Adjustable pressure rise time drive. The patient with neuromuscular disease may also • Adjustable inspiratory trigger require timed support as respiratory effort may be insufficient • Adjustable expiratory trigger to trigger a breath, particularly during sleep.12 • Adjustable inspiratory-expiratory ratio in assist-control Intrinsic positive end expiratory positive pressure (PEEPi) mode is commonly observed in patients with airflow limitation. In • Temporary alarm cancellation facility the intubated paralysed individual it can be measured by • Internal battery with power for at least 1 hour transient occlusion of the airway and reflects the recoil • Accessible control panel with cover or lock-out facility • Simple control knobs pressure of the overinflated lung. In the spontaneously • LED/LCD displays breathing patient PEEPi may be overestimated as abdominal muscle contraction contributes to the positive intrathoracic pressure at end expiration.17 PEEPi is overcome by isometric respiratory muscle contraction before airflow can begin and, alarms that indicate settings which cannot be achieved by the for the patient receiving NIV, a triggered breath initiated. By machine settings such as a larger tidal volume and short offsetting intrinsic PEEP, EPAP therefore helps triggering17 19 inspiratory time. External alarms can be added to the ventila- and, by reducing perceived effort, it improves comfort. tor circuit; these are particularly important for ventilator Although PEEPi may be 10–15 cm H2O in patients with severe dependent patients. acute COPD, levels of EPAP of >5 cm H2O are rarely tolerated.17 Minimum specifications for NIV ventilators There is a bewildering choice of ventilators from which to Oxygen choose when setting up an NIV service. In the setting of acute NIV ventilators entrain room air and, on most machines, oxy- respiratory failure a significant proportion of the patients will gen enrichment requires oxygen to be fed proximally into the have COPD. Most studies which have shown improved circuit or directly into the mask. An FiO2 of about 35% can be survival in COPD with NIV have used ventilators where achieved, but the flow rate of oxygen required will vary inspiratory pressure is the controlled variable, and a bi-level depending on the flow rate of air from the ventilator as it device is probably the preferred mode for this group of attempts to reach the set pressure, and the magnitude of any patients. An assist/control mode will also be necessary for leaks in the circuit. An oxygen analyser inserted into the ven- some of these patients, and also for those with other diseases tilator tubing gives unreliable information and an oximeter to who are likely to make little respiratory effort once established guide oxygen enrichment is more reliable. Higher enrichment on NIV. These requirements can be provided by two different requires premixing which necessitates a high pressure oxygen devices or combined in a single ventilator. Features of a venti- supply. This is only available with ventilators designed for ICU lator suitable for NIV in hospital are shown in box 1. use such as the Respironics Vision or volume control Different ventilatory modes, the ability to change trigger machines. sensitivity, to vary rise time to the set pressure, and to adjust the sensing of the end of inspiration are just some of the fea- Humidification tures of newer ventilators. It must be borne in mind that these Humidification is not normally necessary during NIV. Use of sophisticated options require more operator understanding heated humidifiers or heat/moisture exchangers significantly than is often available, although by increasing comfort they alters the compliance and resistance of the circuit and, in par- may increase tolerance. Use of a single model of ventilator (or ticular, can impair the function of inspiratory and expiratory at least a small number of different types) in any one hospital triggers. is advisable for ease of training staff. An updated list of the features of non-invasive ventilators is Alarms available on the ARTP website (artp.org.uk). Alarms on NIV ventilators are based on pressure, flow, or vol- ume. A low pressure alarm detects disconnection or excessive PATIENT-VENTILATOR INTERFACES leakage which prevents the ventilator achieving the set The sophistication and variety of interfaces reflects how prob- pressure. High pressure alarms may be set on volume control- lematic this aspect of NIV can be. Approximately 20–30% of led ventilators to warn of excessively high pressures (which patients with acute respiratory failure cannot be managed by may arise if the patient’s condition changes and they become NIV.21 22 In some, asynchrony between patient and ventilator is more difficult to inflate, or when a large tidal volume is set the cause and this may result from poor mask fit. In these cir- with a short inspiratory time). Flow alarms are more cumstances, inspiratory effort and end inspiration may fail to informative and can warn of changing leakage, worsening be detected. After semi-continuous use over several days skin airflow obstruction, or partially occluded ventilator tubing. By ulceration, particularly over the nasal bridge, occurs. A barrier measuring flow and assuming constant leakage, some devices dressing may be used from the outset to reduce the risk of this compute tidal volume and hence minute volume; alarm limits complication. Overtightening the head gear in an attempt to can then be set and this type of ventilator offers greater moni- reduce leakage exacerbates skin damage with resulting poor toring potential. Volume controlled ventilators may have compliance. Mask fit is therefore important for comfort and to www.thoraxjnl.com
  • 8. Non-invasive ventilation in acute respiratory failure 199 ensure effective ventilatory support. Training is required for (2) As a trial with a view to intubation if NIV fails. any therapist involved with NIV. More sophisticated “off the (3) As the ceiling of treatment in patients who are not candi- shelf ” masks are available with cushioned gel surrounding the dates for intubation . nasal interface (Gold Seal, Respironics) or comfort flaps that A decision about intubation if NIV fails should be made limit leakage. Alternatively, horizontal rather then vertical early in each patient, taking into consideration the severity of catheter mounts (Blue Horizon, Tiara Medical), nasal plugs the underlying disease and previous level of disability, and (Adams circuit, Nellcor Puritan Bennett or Mallinkrodt), or documented in the notes. The wishes of the patients and their nasal slings (Monarch, Respironics) are available. Although carers should also be taken into account. This decision should the latter may be more comfortable, they leak and are more be verified by senior medical staff and, if appropriate, consul- easily displaced, particularly during sleep. Individually tation with ICU staff should be made at an early stage. moulded masks are popular in some centres and heat sensitive plastics that mould to the face are now commercially • NIV may be undertaken as a therapeutic trial with a view to produced (Profile, Respironics). Laser scanning to produce tracheal intubation if it fails, or as the ceiling of treatment in individual interfaces may become available. At present, the patients who are not candidates for intubation. A decision about cost of these alternative designs restricts them to patients tracheal intubation should be made before commencing NIV in requiring long term NIV. every patient. This should be verified as soon as possible with senior A degree of air leakage through the mouth is common and medical staff and documented in the case notes. [D] may be significant during sleep.23 If chin straps are ineffective in reducing leakage, a full face mask must be employed. COPD Acrylic masks for CPAP can be used but these often produce NIV skin ulceration and leakage is severe in edentulous subjects. A number of prospective randomised controlled trials of NIV As with nasal masks, a better fit is obtained if dentures are left have been published, predominantly in patients with acute in place. Full-face masks may be useful in the uncooperative exacerbations of COPD. The studies performed in the patient, but nasal masks are generally preferable because they ICU21 22 25 26 show that NIV is feasible and that the tracheal are less claustrophobic and allow eating, drinking, and speech. intubation rate is substantially reduced. In the study by Air swallowing is also more problematic with a full-face mask Brochard et al21 most of the excess mortality and complica- and sometimes produces severe abdominal distension. This tions, particularly pneumonia, were attributed to intubation. may limit their use in patients with recent abdominal surgery. These data suggest that NIV may be superior to mechanical Occasional patients are unable to tolerate any mask. Oral ventilation but, importantly, this was a highly selected group interfaces based on a snorkel design are available but require of patients with the majority being excluded from the study. determination on the part of the patient. In patients who are Kramer et al22 also noted a reduction in intubation rate, intolerant of NIV because of nasal obstruction, nasal stents particularly in the subgroup with COPD, but with no can be inserted to restore the patency of the upper airway.24 An difference in mortality. The study by Celikel et al25 showed a updated list of the features of interfaces is available on the more rapid improvement in various physiological parameters ARTP website (artp.org.uk). but there was no difference in intubation rate or survival. • A selection of different sizes of nasal masks, full-face masks, and However, a number of patients in the conventionally treated nasal pillows should be available for NIV. [C] group also received NIV because of clinical deterioration. Mar- tin et al26 have recently reported a prospective randomised • Both nasal and full-face masks have been used successfully for NIV controlled trial comparing NIV with usual medical care in 61 in AHRF. In the acute setting, a full-face mask should be used ini- patients including 23 with COPD. In common with other tially, changing to a nasal mask after 24 hours as the patient studies there was a significant reduction in intubation rate, improves. [D] but there was no difference in mortality. However, generalisa- tion of these results to the UK, where NIV is usually performed INDICATIONS FOR NIV on general wards, is uncertain. There have been a number of uncontrolled studies describing Prospective randomised controlled trials of NIV outside the the use of NIV in a wide range of different conditions. ICU27–30 have shown varying results. In the trial by Bott et al29 Controlled trials have predominantly, but not exclusively, been research staff supernumerary to the normal ward complement carried out in patients with COPD. None of these trials has initiated NIV. On an intention to treat analysis there was no used “sham” NIV as control therapy. Reservations have been difference between the two groups, but when those unable to expressed that some of the benefit seen with NIV could reflect tolerate NIV were excluded a significant survival benefit was the attention given to the patients during the administration seen in the NIV group. In the study by Barbe et al28 the lack of of NIV. A further possibility is that the discomfort of the mask difference between the two groups is not surprising as, given merely prevents the patient from falling asleep; gas exchange the modest level of acidosis at presentation, the majority were deteriorates during sleep and supplementary oxygen is more likely to improve with standard treatment. Wood et al27 found likely to produce rises in PaCO2 than when the patient is awake. a non-significant trend towards increased mortality in those Double blind, placebo controlled trials of NIV in AHRF are given NIV (4/16 v 0/11, p=0.123) which was attributed to unlikely ever to be performed, and conclusions about the indi- delays in intubation. It is difficult to draw many conclusions cations for NIV from the evidence available must therefore be from this study as the two groups were poorly matched and made with caution. the numbers small. In particular, there were more patients There are very few randomised control trials of CPAP in with pneumonia in the NIV group. acute respiratory failure, and most have focused on the treat- A multicentre randomised controlled trial of NIV in acute ment of cardiogenic pulmonary oedema. There is also a lack of exacerbations of COPD (n=236) on general respiratory wards trials comparing CPAP with both NIV and best medical in 13 centres has recently been reported.30 NIV was applied by therapy. Only one randomised controlled trial, again in the usual ward staff according to a simple protocol. cardiogenic pulmonary oedema, is available which compares “Treatment failure”, a surrogate for the need for intubation all three treatments. defined by a priori criteria, was reduced from 27% to 15% by There are three levels at which NIV may be used: NIV (p<0.05). In-hospital mortality was also reduced from (1) As a holding measure to assist ventilation in patients at an 20% to 10% (p<0.05). Subgroup analysis suggested that the earlier stage than that at which tracheal intubation would be outcome in patients with pH <7.30 (H+ >50 nmol/l) after ini- considered. tial treatment was inferior to that in the studies performed in www.thoraxjnl.com
  • 9. 200 BTS Standards of Care Committee the ICU; these patients are probably best managed in a higher NIV dependency setting with individually tailored ventilation. Several case reports and series43–51 have described the use of Staff training and support are crucial wherever NIV is NIV in pulmonary oedema. Mortality in the series varied from performed, and operator expertise more than any other factor 0% to 22% and intubation rates from 0% to 44%. Two recent is likely to determine the success or otherwise of NIV. randomised controlled trials have given conflicting results. It is important to note that all the randomised controlled Masip et al52 showed a more rapid clinical improvement when trials have excluded patients deemed to warrant immediate NIV was compared with oxygen therapy in acute cardiogenic intubation and mechanical ventilation and there has been no pulmonary oedema, with reduced intubation rates but no direct comparison between NIV and invasive ventilation from overall difference in mortality, whereas Sharon et al53 found a the outset in COPD. worse outcome than with intravenous nitrate infusion. In addition to these prospective randomised controlled trials, there have been two studies comparing patients treated CPAP v NIV with NIV with historical controls treated conventionally or One randomised controlled trial of 27 patients compared CPAP with invasive mechanical ventilation. These have shown a with NIV.38 The study was prematurely terminated due to an reduction in intubation rate,31 no difference in hospital increased incidence of myocardial infarction in the NIV group. mortality, but a survival advantage for non-invasively venti- The interim analysis found no difference in hospital mortality lated patients becoming apparent after discharge at 3 months (one death in the NIV group, two deaths in the CPAP group) or and 1 year.31 32 need for intubation (one in each group). Comparison of the two groups at entry showed that more patients with chest CPAP pain were entered into the NIV limb, raising the possibility of There are no randomised controlled trials of CPAP in the entry mismatch as an explanation for the higher number of treatment of respiratory failure in COPD. A number of case myocardial infarctions in the NIV treated group. series have reported beneficial affects of CPAP, including an increase in PaO2, decrease in PaCO2, and a fall in respiratory • CPAP has been shown to be effective in patients with cardiogenic rate.17 33–36 Two of the series35 36 reported an intubation rate of pulmonary oedema who remain hypoxic despite maximal medical 10–30% despite CPAP. The trials of NIV in COPD suggest that treatment. NIV should be reserved for patients in whom CPAP is CPAP may now be an irrelevant treatment in patients with unsuccessful. [B] COPD. However, CPAP remains more readily available, is Chest wall deformity/neuromuscular disease cheaper, and requires less training for use. There is some evi- Successful NIV has been described54 and, given the success in dence for the use of CPAP in COPD and randomised controlled chronic ventilatory failure, NIV should be considered the trials comparing CPAP with NIV could be justified. Studies on treatment of choice in decompensated ventilatory failure due the benefits or risks of EPAP in NIV are also needed. to chest wall deformity and neuromuscular disease. There are Doxapram no randomised controlled trials and very few case reports of Angus et al37 compared doxapram with NIV; NIV was found to NIV in these patient groups, and it is now very unlikely that a be more effective and the protocol had to be changed to allow randomised controlled trial will ever be performed. There is the introduction of ventilatory support following three deaths good evidence of long term survival benefit with home venti- in the doxapram group. Doxapram may be used while the lation, with 5 year survival of around 80%.55 The decision to patient is transferred to an area where NIV can be started, if use NIV will, however, depend upon the severity of the venti- NIV is not available, or if it cannot be tolerated by the patient. latory failure, the presence or absence of bulbar involvement, In some patients who remain drowsy on NIV or who are par- and the availability of other effective treatments—for exam- ticularly prone to carbon dioxide retention it may be necessary ple, in myasthenia gravis and Guillain-Barré syndrome. to combine NIV and doxapram. • NIV is indicated in acute or acute-on-chronic hypercapnic respira- • NIV should be considered in patients with an acute exacerbation of tory failure due to chest wall deformity or neuromuscular disease. COPD in whom a respiratory acidosis (pH <7.35, H+ >45 nmol/l) [C] persists despite maximum medical treatment on controlled oxygen Decompensated obstructive sleep apnoea therapy. [A] NIV has been used successfully in this condition56 and patients Cardiogenic pulmonary oedema admitted acutely with hypercapnic respiratory failure should CPAP be given a trial of NIV. CPAP has also been used in the The best evidence for the efficacy of CPAP in any type of respi- treatment of patients with severe decompensated OSA.57 58 ratory failure comes from four randomised controlled • Both CPAP and NIV have been used successfully in patients with trials38–41 and a systematic review with meta-analysis42 in decompensated obstructive sleep apnoea. Although no direct cardiogenic pulmonary oedema. comparison is available, NIV (in the form of bi-level pressure sup- Three trials39–41 compared CPAP with medical treatment port) should be used for these patients if a respiratory acidosis is alone. Important exclusions from the trials included patients present. [C] unresponsive to speech or who were unable to maintain their own airways. A number of patients were hypercapnic upon Chest trauma entry. A total of 180 patients were entered into the three stud- One randomised controlled trial59 and two case series60 61 sup- ies and primary end points were the need for intubation and port the use of CPAP in isolated chest trauma. A trial was per- hospital mortality. Two of the studies39 41 applied a fixed CPAP formed on 69 patients with more than two rib fractures and of 10 cm H2O while the third40 titrated CPAP from 2.5 to hypoxaemia.59 CPAP and regional analgesia were compared 12.5 cm H2O. All three studies found a survival benefit with with immediate intubation followed by intermittent positive CPAP although individual trial 95% confidence intervals pressure ventilation (IPPV) with PEEP. The randomisation included zero effect. All three also found a reduction in the method was not described in the study and it was clearly need for intubation with CPAP. The systematic review by Pang impossible to blind treatment. The injury severity score was et al42 concluded that all three trials were well conducted. also higher in the intubated group. CPAP resulted in fewer Pooled data showed a decreased need for intubation with treatment days (mean 4.5 v 7.3), mean ICU days (5.3 v 9.5), CPAP (risk difference –26%, 95% CI –13 to –38) and a trend to and hospital days (8.4 v 14.6). Both deaths occurred in the decreased hospital mortality (risk difference –6.6%; 95% CI 3 intubated group. It should be noted that patients with greater to –16). than moderate lung injury, as defined by a PaO2 of <8 kPa on www.thoraxjnl.com
  • 10. Non-invasive ventilation in acute respiratory failure 201 an FiO2 of 40% or greater, were excluded from the study. The with cystic fibrosis72 where invasive ventilation produces a use of IPPV in the control group, with relatively mild gas uniformly poor outcome. There is insufficient evidence to rec- exchange problems, could be challenged in view of more ommend its routine use in these patients. recent evidence of adverse effects associated with barotrauma. • A trial of NIV may be undertaken in patients with a respiratory When CPAP is used in patients with rib fractures it is impor- acidosis (pH<7.35) secondary to an acute exacerbation of tant to realise that there is the risk of developing a pneumot- bronchiectasis, but excessive secretions are likely to limit its effective- horax similar to that with invasive ventilation. ness and it should not be used routinely in bronchiectasis. [C] • CPAP should be used in patients with chest wall trauma who remain hypoxic despite adequate regional anaesthesia and high flow Other conditions oxygen. [C] NIV should not be used routinely. [D] Case series have reported success with NIV in a variety of other conditions such as adult respiratory distress • In view of the risk of pneumothorax, patients with chest wall syndrome.73 Two randomised trials of NIV have included trauma who are treated with CPAP or NIV should be monitored on patients with a wide range of conditons other than COPD, the ICU. [D] although pneumonia and cardiogenic pulmonary oedema were the most common diagnoses in both. Wysocki et al74 ran- Pneumonia domised 41 patients to NIV or conventional treatment and Confalonieri et al62 have reported a prospective randomised found no difference in intubation rate, length of ICU stay, or controlled trial of 56 consecutive patients with community mortality, with benefit experienced only by the subgroup with acquired pneumonia randomised to receive conventional hypercapnia. In a more recent study Antonelli et al75 conducted treatment alone or with the addition of NIV. NIV was well tol- a prospective randomised controlled trial of NIV against erated, safe, and associated with a significant reduction in res- tracheal intubation with conventional mechanical ventilation piratory rate, need for tracheal intubation (21% v 50%; in 64 patients with hypoxaemic acute respiratory failure who p=0.03), and meaan (SD) duration of ICU stay (1.8 (0.7) days required mechanical ventilation. There was no statistically v 6.0 (1.8) days; p=0.04). There was no difference in hospital significant difference in survival but more patients in the con- mortality, but in the subgroup with co-existing COPD those ventional ventilation group had serious complications (66% v randomised to NIV had an improved 2 month survival (88.9% 38%, p=0.02) and had pneumonia or sinusitis related to the v 37.5%; p=0.05). tracheal tube (31% v 3%, p=0.003). Among the survivors, CPAP has been used in the treatment of severe community patients in the NIV group had shorter periods of ventilation acquired pneumonia,63 varicella pneumonia,63 and has become (p=0.006) and shorter stays in the ICU (p=0.002). They con- standard treatment for the treatment of pneumocystis cluded that, in patients with acute respiratory failure, NIV was pneumonia in immunosuppressed patients (particularly those as effective as conventional ventilation in improving gas who are HIV positive). Numerous case series and reports64–69 exchange and was associated with fewer serious complica- have shown that CPAP improves oxygenation, reduces respira- tions and a shorter stay in the ICU. tory rate, and lessens dyspnoea in this situation. In a More recently, Antonelli et al76 have reported the results of a randomised controlled trial of CPAP in 123 patients with non- randomised controlled trial of NIV in solid organ transplant hypercapnic acute respiratory failure, 51 of whom had recipients who developed type 1 respiratory failure. A more pneumonia, oxygenation and dyspnoea scores were better in rapid improvement in oxygenation and a reduction in intuba- the CPAP group after 1 hour; however, there were no tion rate was found with NIV. Hilbert et al77 have shown a significant differences in intubation rates, mortality, or length reduction not only in intubation rate but also in mortality in a of ICU stay.70 There were more adverse effects in the CPAP randomised controlled trial of NIV in immunosuppressed group, including four cardiorespiratory arrests, presumably patients with type 1 respiratory failure. secondary to delayed intubation. • NIV has been used in a variety of other conditions (such as acute • CPAP improves oxygenation in patients with diffuse pneumonia respiratory distress syndrome, postoperative or post-transplantation who remain hypoxic despite maximum medical treatment. NIV can respiratory failure) with reduced intubation rates, ICU stay, and be used as an alternative to tracheal intubation if the patient mortality. In this context, patients who would be considered for becomes hypercapnic. [C] In this context, patients who would be intubation if NIV fails should only receive NIV in an ICU. [D] candidates for intubation if NIV fails should only received NIV in an ICU. [D] Weaning in the ICU Nava et al78 compared weaning using NIV or continued invasive Asthma ventilation in 50 patients who had been intubated and venti- Meduri et al71 reported successful use of NIV in 17 episodes of lated either from the outset or following a failed trial of NIV. status asthmaticus. Mean pH was 7.25 (H+ 56 nmol/l) After 48 hours patients on invasive ventilation were subjected confirming severe acute respiratory failure, and NIV resulted to a 2 hour T piece trial; those who failed were randomised to in a rapid improvement in physiological variables; only two extubation onto a non-invasive ventilator or continued patients required intubation. Although NIV has been used invasive ventilation. Similar weaning strategies were em- successfully in patients with acute asthma, there is insuffi- ployed in the two groups and there was a clear advantage for cient evidence to recommend its use in this context. There is the non-invasive approach in the percentage of patients also insufficient evidence to recommend CPAP in acute successfully weaned, duration of need for assisted ventilation, asthma. ICU stay, survival, and incidence of ventilator associated • NIV should not be used routinely in acute asthma. [C] pneumonia. This suggests a role for NIV in patients who initially have had to be ventilated invasively. Cystic fibrosis/bronchiectasis Girault et al79 compared NIV with continued invasive venti- There are no randomised controlled trials of NIV versus lation in a randomised study on 33 patients who failed a conventional treatment in these patient groups. Physiologi- T-piece trial. The patients who received NIV could be extubated cally, they are similar to patients with COPD with evidence of earlier, but there was no difference in the number who could severe airflow obstruction. However, in addition, secretions are be weaned, the length of ICU stay, or survival at 3 months. often excessive and this may limit the applicability of NIV. NIV NIV can be used through the upper airway while a trache- can be used as an adjunct to physiotherapy, but evidence for its ostomy tube is in place. The tube can be capped off provided effectiveness in clearing secretions is lacking. NIV has been the cuff is deflated. It is sometimes not possible to achieve used successfully as a bridge to transplantation in patients effective ventilation with NIV despite deflating the cuff www.thoraxjnl.com
  • 11. 202 BTS Standards of Care Committee Taken together, these data suggest that NIV is more likely to Table 1 Factors associated with success or failure in be successful in patients with a less severe physiological NIV derangement at baseline in whom there is a rapid improve- Success Failure ment in pH and respiratory rate with NIV and in whom it is possible to achieve a reasonable fit between the mask and the High PaCO2 with low A–a oxygen gradient High APACHE score patient’s face. However, it is not possible at the outset to pre- pH 7.25–7.35 (H+ 56–45 nmol/l) Pneumonia on chest radiography dict who will derive benefit from NIV. Factors associated with the success or failure of NIV are Improvement in pH, PaCO2, and respiratory Copious respiratory rate after 1 hour of NIV secretions shown in table 1. Good level of consciousness Edentulous Poor nutritional status CONTRAINDICATIONS Confusion or impaired The boundaries for the use of NIV continue to expand. consciousness However, intubation and conventional ventilation remain the “gold standard” in the management of many patients with acute respiratory failure. Local protocols need to be developed in order to avoid inappropriate trials of NIV in patients who require urgent intubation. NIV is not appropriate in well because there is insufficient gap between the tracheostomy documented end stage disease or when several co-morbidities tube and the tracheal wall. NIV is easier with a smaller are present. There are no absolute contraindications although uncuffed fenestrated tracheostomy tube in place. This can be a number have been suggested.80 82 These include coma or con- changed to a mini-tracheostomy tube for a few days if access fusion, inability to protect the airway, severe acidosis at pres- to the lower respiratory tract is still required for aspiration of entation, significant co-morbidity, vomiting, obstructed bowel, secretions. haemodynamic instability (two studies have shown only small • NIV has been used successfully to wean patients from invasive ven- changes in cardiac output when NIV is initiated62 82 but tilation and should be used when conventional weaning strategies haemodynamic collapse comparable to that often seen when fail. [B] patients are intubated is seldom seen), radiological evidence of consolidation, and orofacial abnormalities which interfere Predictors of outcome of NIV in acute respiratory with the mask/face interface. In part, these “contraindica- failure tions” have been determined by the fact that they were exclu- An improvement in pH22 29 and a reduction in respiratory sion criteria for the controlled trials. It is therefore more cor- rate22 after 1 hour has been shown to be associated with a rect to state that NIV is not proven in these circumstances successful outcome from NIV. Soo Hoo et al80 in a small study rather than that it is contraindicated. Other “contraindica- (14 episodes in 12 patients), in which NIV was successful in tions” such as failure of pH to improve within one hour82 are a 50% of cases, found that there were no differences in age, self-fulfilling prophecy if they have been determined from the prior pulmonary function, baseline arterial blood gas outset as indicating a failure of treatment. Whether NIV is tensions, admission arterial blood gas tensions, or respiratory contraindicated or not must depend on individual circum- rate between those patients successfully treated and those stances. For instance, if invasive ventilation is not considered who failed NIV. Unsuccessfully treated patients had appropriate but NIV would be acceptable, there is nothing to more severe illness than successfully treated patients, as be lost by a trial of NIV and there are no contraindications. By indicated by a higher Acute Physiology and Chronic Health contrast, in an individual moribund with life threatening Evaluation (APACHE) II score, and had pneumonia or excess asthma who may be very difficult to ventilate non-invasively secretions. In addition, they were edentulous and had pursed but in whom no problems with weaning would be anticipated, lip breathing—factors that prevented adequate mouth seal there is little to be gained and much to be lost by attempting and contributed to greater mouth leaks than in successfully NIV. treated patients. Successfully treated patients were able to NIV has been used in patients with an undrained pneumot- adapt more rapidly to the nasal mask and ventilator, with horax without apparently causing the pneumothorax to greater and more rapid reduction in PaCO2, correction of pH, increase in size.83 However, in most patients with a pneumot- and reduction in respiratory rate. In a study of NIV in 17 con- horax it will be appropriate to insert an intercostal drain secutive patients with respiratory failure of various causes,81 before commencing NIV. NIV was successful in 47%; patients successfully ventilated Contraindications to the use of NIV are listed in box 2. with NIV had a higher PaCO2, a lower pH (7.33 (0.03) v 7.45 (0.08); p=0.02), and a lower alveolar–arterial oxygen difference (P(A–a)O2) (144 (46) mm Hg v 265 (18) mm Hg; Box 2 Contraindications to NIV p=0.01), suggesting that CO2 retention without major hypoxaemia is a better indication for NIV than severe • Facial trauma/burns • Recent facial, upper airway, or upper gastrointestinal tract* hypoxaemia alone. In both groups of patients gas exchange surgery improved after 1 hour on NIV, but such values were • Fixed obstruction of the upper airway not improved on the first day in patients who failed with • Inability to protect airway* NIV. • Life threatening hypoxaemia* Ambrosino et al 82 in a larger study of 59 episodes in 47 • Haemodynamic instability* patients of which 78% were successfully treated with NIV • Severe co-morbidity* found that success was more likely with less severely • Impaired consciousness* abnormal baseline clinical and functional parameters and • Confusion/agitation* with less severe levels of acidosis. Pneumonia was associated • Vomiting • Bowel obstruction* with a worse outcome. However, Confalonieri et al62 in a study • Copious respiratory secretions* of NIV in community acquired pneumonia found that NIV • Focal consolidation on chest radiograph* reduced the tracheal intubation rate overall but only improved • Undrained pneumothorax* 2 month survival in the subgroup with COPD. This suggests that there is still a role for NIV in patients with radiological *NIV may be used, despite the presence of these contraindications, if it is to be the “ceiling” of treatment. consolidation. www.thoraxjnl.com
  • 12. Non-invasive ventilation in acute respiratory failure 203 • NIV should not be used in patients after recent facial or upper air- be able to carry out these measurements rather than relying way surgery, in the presence of facial abnormalities such as burns or on the duty doctor. Timing of arterial blood gas measure- trauma, if there is fixed obstruction of the upper airway, or if the ment will depend on the patient’s condition and response to patient is vomiting. [D] treatment. In most studies workers have made measure- • Contraindications to NIV include recent upper gastointestinal ments at 0, 1 hour, 4 hours, and varying intervals thereafter. surgery, inability to protect the airway, copious respiratory secretions, During the first 24 hours the use of an indwelling arterial life threatening hypoxaemia, severe co-morbidity, confusion/ line should be considered and this is more likely in an agitation, or bowel obstruction. NIV can be used in the presence of ICU/HDU. these contraindications provided contingency plans for tracheal All patients must routinely have a clinical re-assessment intubation have been made, or if a decision has been made not to approximately 1 hour after being established on NIV, together proceed to invasive ventilation. [C] with blood gas analysis. Frequency of subsequent measure- • Although NIV has been used successfully in the presence of a pneu- ments will depend on the patient’s progress. In cases where mothorax, in most patients with a pneumothorax an intercostal the patient’s clinical condition is rapidly improving, blood drain should be inserted before commencing NIV. [C] samples should not be taken frequently as these patients are often sleep deprived and need to correct this. When there is no improvement or it is very slow, more frequent assessment MONITORING should be made to guide FiO2, ventilator setting, or interface Monitoring of patients on NIV should include clinical assess- adjustments. A further assessment (with or without blood gas ment combined with pulse oximetry and arterial blood gas analysis) should be taken within 1 hour of any change in FiO2 tensions. The actual monitoring will vary depending on the or ventilator setting. location in which they receive treatment and therefore, to It is important to realise that failure of improvement in some extent, the underlying aetiology of respiratory failure, arterial blood gas tensions is not an indication for simply whether the patient is a candidate for ventilation, and whether increasing the FiO2 but for clinical re-evaluation of the patient. there is other co-morbidity. Patients in the ICU or HDU are likely to be monitored according to the routines adopted in Any changes in oxygenation cannot be assessed in the absence those environments. of information regarding the inspired oxygen concentration, and it is vital that the metered flow rate and the mode of sup- Clinical evaluation plementation are clearly recorded. Physiological monitoring is not a substitute for clinical assess- • Clinical evaluation of the patient should include assessment of ment and observation of the patient on the ventilator should patient comfort, conscious level, chest wall motion, accessory muscle be made regularly. Clinical features that should be assessed recruitment, coordination of respiratory effort with the ventilator, are: respiratory rate, and heart rate. Patients receiving NIV should be • Chest wall movement reviewed regularly to assess their response to treatment and to opti- mise the ventilator settings. [D] • Coordination of respiratory effort with the ventilator • Accessory muscle recruitment • The need for arterial blood gas analysis will be governed by the patient’s clinical progress, but should be measured in most patients • Heart rate after 1–2 hours of NIV and after 4–6 hours if the earlier sample • Respiratory rate showed little improvement. If there has been no improvement in • Patient comfort PaCO2 and pH after this period, NIV should be discontinued and • Mental state invasive ventilation considered. [B] When initiating NIV it is important that the therapist • Oxygen saturation should be monitored continuously for at least 24 observes the effect of treatment in enhancing chest wall hours after commencing NIV and supplementary oxygen adminis- movement. Lack of an improvement indicates that alveolar tered to maintain saturations between 85% and 90%. [C] ventilation is not increasing and causes should be sought. These include inappropriate ventilator settings leading to Treatment failure patient intolerance, inadequate tidal volume or inflation pres- Assessment and definition of treatment failure will depend on sure, and leaks around the mask or through the open mouth. the role of NIV in individual patients which should be estab- Monitoring of heart and respiratory rate is essential and can lished before the trial of NIV. However, factors to take into be helpful in determining the response to treatment early on, account are: before other physiological measurements are made.9 21 51 52 84–87 Improvement in breathlessness is usually seen within 1–2 • Deterioration in patient’s condition hours21 51 87 88 and is usually accompanied by improvement in • Failure to improve or deterioration in arterial blood gas ten- the neurological state.32 74 89 sions • Development of new symptoms or complications such as Oxygen saturation and arterial blood gas tensions pneumothorax, sputum retention, nasal bridge erosion In published studies of NIV, data on oxygen saturation or transcutaneous CO2 have seldom been reported. However, sev- • Intolerance or failure of coordination with the ventilator eral studies have shown that oxygen levels improve early with • Failure to alleviate symptoms NIV21 49 85 86 88 89 and, on this basis, SpO2 monitoring is likely to • Deteriorating conscious level be helpful, although does not replace the need for frequent measurements of arterial blood gas tensions in the early • Patient and carer wish to withdraw treatment stages of treatment. Ideally, there should be continuous moni- Some of the alterations to NIV which can be made if arterial toring of SpO2 for the first 24 hours of treatment, aiming to blood gases fail to improve are shown in box 3. A management keep saturation above 85%, with supplemental oxygen if nec- plan of what to do if NIV fails should be made early, ideally by essary. Transcutaneous CO2 monitoring may also be used a respiratory physician. Likewise, the decision to progress to where it is available. intubation should be made by an experienced clinician in Arterial or arterialised capillary blood gas analysis of consultation with ICU staff. pH, PaCO2. and PaO2 are critically important in the assessment The expected improvement in arterial blood gas tensions of patients on NIV and, ideally, staff providing NIV should with NIV varies and is affected by the underlying pathology www.thoraxjnl.com
  • 13. 204 BTS Standards of Care Committee NIV (1–21 days).90 Many workers in this field believe that, in Box 3 Treatment failure in NIV the early phase of treatment (the first 24 hours or until improving), the patient should be ventilated for as many hours Is the treatment of the underlying condition optimal? as possible as clinically indicated and can be tolerated, and this • Check medical treatment prescribed and that it has been is borne out by one randomised controlled trial.21 given Clinical improvement and stability of the patient’s condi- • Consider physiotherapy for sputum retention tion are the most important factors in determining when NIV Have any complications developed? may be safely withdrawn. It is often recognised by patients who independently decide to cease use of the machine. One • Consider a pneumothorax, aspiration pneumonia, etc study indicated that the mode of weaning is to reduce periods Paco2 remains elevated of ventilation according to clinical criteria, reducing diurnal • Is the patient on too much oxygen? ventilation before nocturnal.91 Another study has suggested a • Adjust FiO2 to maintain SpO2 between 85% and 90% respiratory rate of <24 breaths/min, heart rate <110 • Is there excessive leakage? beats/min, compensated pH >7.35 (H+ <45 nmol/l), and SpO2 • Check mask fit >90% on FiO2 <4 l/min.21 • If using nasal mask, consider chin strap or full-face • Breaks from NIV should be made for drugs, physiotherapy, meals, mask etc. Patients who show benefit from NIV in the first few hours • Is the circuit set up correctly? should be ventilated for as much as possible during the first 24 • Check connections have been made correctly hours, or until improving. [B] • Check circuit for leaks • Is re-breathing occurring? • Check patency of expiratory valve (if fitted) Indications for referral for domiciliary NIV • Consider increasing EPAP (if bi-level pressure Most patients treated with NIV for acute respiratory failure support) can be weaned from ventilatory support within a few days. If • Is the patient synchronising with the ventilator? NIV is still needed more than one week after the acute • Observe patient episode, this may be an indication that longer term NIV will be • Adjust rate and/or IE ratio (with assist/control) necessary and consideration should be given to referring the • Check inspiratory trigger (if adjustable) patient to a centre providing home NIV. • Check expiratory trigger (if adjustable) On recovery, all patients who have been treated with NIV • Consider increasing EPAP (with bi-level pressure sup- should undergo spirometric testing and arterial blood gas port in COPD) analysis while breathing air before discharge from hospital. In • Is ventilation inadequate? accordance with RCP guidelines,92 if the pre-discharge arterial • Observe chest expansion blood gas measurement shows a PaO2 of <7.3 kPa in patients • Increase target pressure (or IPAP) or volume with COPD, a repeat measurement should be made after an • Consider increasing inspiratory time interval of at least 3 weeks. If hypoxaemia persists, a trial of • Consider increasing respiratory rate (to increase oxygen will normally be warranted and, at this stage, noctur- minute ventilation) nal NIV can be considered if the patient is hypercapnic while • Consider a different mode of ventilation/ventilator, if breathing air or if the PaCO2 rises significantly with administra- available tion of sufficient supplementary oxygen to correct the hypox- Paco2 improves but Pao2 remains low aemia. It has also been suggested that long term domicilary • Increase FiO2 NIV should be considered in patients with COPD who have • Consider increasing EPAP (with bi-level pressure support) had three or more episodes of acute hypercapnic respiratory failure in the previous year. The role of long term nocturnal NIV in COPD is not yet clearly established. Nocturnal NIV in patients with chronic respiratory failure and severity of respiratory decompensation. Most trials which secondary to restrictive chest wall abnormalities is associated describe a positive response to treatment, including ran- with prolonged survival. Any patient with neuromuscular dis- domised controlled trials, have noted an early improvement in ease or chest wall deformity who has an episode of hypercap- PaO2, pH, and PaCO2. This is usually evident at 1 hour and cer- nic respiratory failure must be referred to a specialist unit for tainly at 4–6 hours. Lack of progress towards correction of dis- assessment of long term domiciliary therapy.93 Similarly, turbance of these parameters has been associated with failure patients with cervical cord lesions who have an episode of of NIV.21 50 A degree of stability should be reached by 4–6 acute respiratory failure should be referred to a spinal injuries hours. unit for assessment. The point at which NIV should be abandoned and the Many patients with respiratory failure are overweight and it patient intubated will vary with each individual, but will can be difficult to quantify the contribution of obesity to their include considerations such as severity of ventilatory failure, respiratory problems. Patients with morbid obesity (BMI >30) likelihood of difficulty weaning from invasive ventilation, the who develop hypercapnic respiratory failure may have a patient’s wishes, and whether there are factors such as exces- central respiratory drive problem or decompensated obstruc- sive secretions which could be better managed if the patient tive sleep apnoea, and on recovery and they should also be was intubated. If NIV is clearly failing to palliate a patient’s referred for further investigation. symptoms and they are not candidates for intubation, NIV Indications for referral for consideration of long term NIV should be stopped and alternative treatment considered. are shown in box 4. Withdrawal of NIV • All patients who have been treated with NIV for acute hypercapnic The duration of NIV required is very variable. However, unlike respiratory failure should undergo spirometric testing and arterial IPPV, it is not mandatory or continuous even in the acute blood gas analysis while breathing air prior to discharge. [C] phases of treatment, with patients having periods off the ven- • All patients with spinal cord lesions, neuromuscular disease, chest tilator for other treatment such as nebulisers or for meals. wall deformity, or morbid obesity who develop acute hypercapnic Studies vary considerably in the extent of treatment in the respiratory failure should be referred for assessment to a centre pro- first 24 hours (4–20 hours/day) as well as the total duration of viding long term ventilation at home. [C] www.thoraxjnl.com
  • 14. Non-invasive ventilation in acute respiratory failure 205 Hence, NIV can be used in a variety of “high dependency” Box 4 Indications for referral for consideration of locations where it has been shown to be effective. Location long term NIV will be dependent on the degree of acidosis on arterial blood gas analysis, the predetermined role of NIV in • Failure to wean from NIV individual patients, and the available cohort of staff with • Acute hypercapnic respiratory failure secondary to: experience. There should be a designated place in each hospi- • Spinal cord lesion tal, together with structures to ensure that patients are • Neuromuscular diseases transferred to this area with the minimum of delay. At • Chest wall deformity (e.g. scoliosis, thoracoplasty) present this is unlikely to be in the medical admissions unit • Morbid obesity (BMI >30) or accident and emergency setting. The studies vary greatly in • COPD with: time from admission to when NIV is started and there is, as • Recurrent AHRF (>3 episodes) requiring treatment yet, little evidence of benefit from starting NIV early. The with NIV exception is cardiac failure where evidence suggests that • Intolerance of supplementary oxygen (because of CPAP should be started as early as possible following the CO2 retention) with symptomatic sleep disturbance decision to use it. • NIV can be provided in a number of locations including the inten- sive care unit, a high dependency unit, or a respiratory ward. How- USING NIV IN THE HOSPITAL SETTING ever, each hospital should have a specific designated area with an Why set up an acute NIV service? available cohort of staff with appropriate experience, together with NIV is becoming established as an important modality in the structures to ensure that patients requiring NIV can be transferred management of acute respiratory failure. The skills required to this area with the minimum of delay. [C] are easily learnt and the equipment required is relatively inex- • The clinical area in which a patient is treated with NIV will pensive. If an acute NIV service is not provided, the shortage of be influenced by several factors including their clinical state, ICU beds means that some patients will die because facilities whether they will be intubated if NIV fails, and the availablility of to ventilate them invasively are not available. Even if they are beds. Taking into account the overall clinical picture, patients with intubated, some patients will die unnecessarily from compli- more severe acidosis (pH <7.30, H+ >50 nmol/l) should be man- cations such as pneumonia which they would not have devel- aged in a higher dependency area such as an HDU or ICU, as oped if they had been ventilated non-invasively. These factors should those in whom improvement in clinical state and arterial must be weighed against the potential disadvantages of an blood gas tensions is not seen after 1–2 hours of NIV on a respira- acute NIV service, the most important of which is that severely tory ward. [C] ill patients might receive NIV when intubation and invasive ventilation would be more appropriate. • Patients with acute hypercapnic respiratory failure from a cause where the role of NIV is not yet clearly established (such as pneumonia, ARDS, asthma) should only receive NIV in an HDU or Who should be responsible for the NIV service? ICU where facilities for immediate tracheal intubation are There should be a named consultant who has overall respon- available. [C] sibility for the acute NIV service. This will usually be a respira- tory physician, but might also be a consultant nurse specialist or clinical scientist. This person will have responsibility for Who should decide to start NIV? identifying an area where NIV is to be based, and ensuring In most hospitals in the UK the acute take is managed by gen- that the appropriate equipment is available and maintained. eral physicians with a speciality interest and a respiratory They will be responsible for the protocols used, which must be team will not be on call each night. A simple protocol is there- kept up to date. They must organise training for staff and fore required to guide the on call staff as to when NIV should ensure that audit is undertaken on a regular basis. be instituted (see box 5). A number of studies have used simi- lar guidelines.21 22 29 Regular educational sessions will be • A named consultant should have overall responsibility for the NIV needed to ensure that medical staff are familiar with NIV and service. This will usually be a consultant respiratory physician. [D] with these protocols. All patients started on NIV should be transferred to the care of a respiratory physician as soon as Where should this be done? possible. Prospective randomised controlled trials of the use of NIV • There should be a clear protocol for the on-call medical staff as to the have shown that NIV can be set up and successfully used on indications for NIV, how to initiate treatment, and who has ICU, HDU, respiratory wards, and general wards. These have continuing responsibility for supervision of the patient. [D] been formal studies with funding and manpower support, often conducted in university hospitals. Other observation studies in district general hospitals in the UK have shown Who should set up and maintain NIV? successful use of NIV on a general medical and specialist res- ICU staff, doctors, physiotherapists, lung function technicians, piratory ward.88 The largest study in a variety of hospitals was clinical scientists and nurses have all been reported to set up done in Yorkshire and this showed that NIV could be used on and maintain NIV successfully. In the 1997 UK survey setting general and respiratory wards.30 There have been no studies up was reported to be by nurses in 15%, physiotherapists in comparing the efficiency of NIV between ICU, HDU, general 9%, doctors in 33%, and a combination in 41% .94 In the largest wards, and respiratory wards. multicentre study trained nurses set up NIV in almost all hos- A survey of hospitals in the UK in 1997 showed that, where pitals. There have been no studies comparing the success of it was being used, NIV was being undertaken on a general any of these groups in setting up. Some studies have only used ward in 16%, on a respiratory ward in 24%, on HDU in 12%, on NIV during the day, but if it is to be used outside normal ICU in 13%, and on a combination in 34%.94 There are early working hours, nurses or physiotherapists will probably need data suggesting that a low pH (<7.3, H+ >50 nmol/l) and a to be involved. Outside the ICU or HDU the on-call medical high PaCO2 following initial resuscitation increases the rate of staff will probably not have the time to set up NIV. A sample failure with NIV, as does a failure of pH change at 4 hours in protocol for setting up NIV is given in box 6 and typical initial ward based NIV.3 It is possible that success would be improved ventilator settings for bi-level pressure support in a patient for these patients by more aggressive ventilation in a higher with acute hypercapnic respiratory failure due to COPD are dependency setting. shown in table 2. www.thoraxjnl.com
  • 15. 206 BTS Standards of Care Committee Box 5 When to use non-invasive ventilation Box 6 How to set up non-invasive ventilation Patients (1) Decide about management plan if trial of NIV fails, after • COPD discussion with senior medical staff, and document in the • Chest wall deformity, neuromuscular disorder, decompen- notes. sated OSA (2) Decide where trial of NIV should take place (ICU, HDU, • Cardiogenic pulmonary oedema, unresponsive to CPAP or respiratory ward). (3) Consider informing ICU. Blood gases (4) Explain NIV to the patient. • Respiratory acidosis (PaCO2 >6.0 kPa, pH <7.35 or H+ (5) Select a mask to fit the patient and hold it in place to >45 nmol/l) which persists despite maximal medical treat- familiarise the patient. ment and appropriate controlled oxygen therapy (patients (6) Set up the ventilator (see table 2). with pH <7.25 or H+ >56 nmol/l respond less well and (7) Attach pulse oximeter to patient. should be managed in an HDU/ICU). (8) Commence NIV, holding the mask in place for the first • Low A–a oxygen gradient (patients with severe life few minutes. threatening hypoxaemia are more appropriately managed (9) Secure the mask in place with straps/headgear. by tracheal intubation). (10) Reassess after a few minutes. (11) Adjust settings if necessary (see box 3). Clinical state (12) Add oxygen if SpO2 <85%. • Sick but not moribund (13) Instruct the patient how to remove the mask and how to • Able to protect airway summon help. • Conscious and cooperative (14) Clinical assessment and check arterial blood gases at • Haemodynamically stable 1–2 hours. • No excessive respiratory secretions (15) Adjust settings/oxygen if necessary. • Few co-morbidities (16) Institute alternative management plan if PaCO2 and pH have deterioriated after 1–2 hours of NIV on optimal Contraindications excluded settings. If no improvement, consider continuing with NIV • Facial burns/trauma/recent facial or upper airway surgery and reassess with repeat arterial blood gas analysis • Vomiting after 4–6 hours. If no improvement in PaCO2 and pH by • Fixed upper airway obstruction 4–6 hours, institute alternative management plan. • Undrained pneumothorax Premorbid state • Potential for recovery to quality of life acceptable to the monitoring of NIV. In deciding on the location of the NIV patient service, it may be advisable to start NIV in one area such as an • Patient’s wishes considered ICU or HDU and subsequently roll it out to other wards. Training Early work suggested that NIV required extra nursing In 1997 NIV was available in 48% of hospitals surveyed in the time.94 Extra time is required to set up NIV when compared UK.94 Lack of training and finance were the major reasons why with routine care, but maintenance of the patient on NIV does a service had not been set up. At present there are no not require a large amount of extra nursing or physiotherapy recognised guidelines for the training of staff undertaking NIV time.25 28 95 96 However, nursing numbers, especially at night, techniques. This has the potential of leading to widespread should reflect the number of patients on ventilators. variations in clinical practices across the UK. One of the diffi- culties in the development of guidelines is that NIV services • Trained ICU staff, doctors, physiotherapists, lung function techni- may be provided by a wide range of disciplines within the cians, and nurses can successfully set up and maintain NIV. When multiprofessional care team. Each discipline has a different setting up an acute NIV service, it is recommended that NIV to be baseline knowledge so the start point of training packages will initiated and run by nursing staff. [C] vary. If training standards are to be developed to fulfil both local and national requirements, then the range of entry levels SETTING UP AND RUNNING AN NIV SERVICE to these programmes will need to be considered. In setting up a NIV service the involvement of senior staff in A training programme for the provision of an NIV service the initial stages is crucial to success. There should be at least should provide a combination of knowledge based learning one member of staff who has spent time in a centre which supported by clinical experience in the workplace. This should already has an established service. Matters to be considered include: are the purchase of ventilators and disposables, identification • Understanding of normal respiratory anatomy and physiol- of which staff will initiate and maintain NIV, training (see ogy below), and drawing up agreed protocols for initiation and • Understanding of the pathophysiology of respiratory failure • Understanding of treatment options available to the Table 2 Typical initial ventilator relevant patient population settings for bi-level pressure support in • Awareness of signs demonstrating worsening respiratory a patient with acute hypercapnic failure respiratory failure due to COPD • Understanding of the operation, maintenance, and trouble- Mode Spontaneous/timed shooting of NIV equipment EPAP 4–5 cm H2O IPAP 12–15 cm H2O (to be increased • Knowledge of patient interfaces used in NIV as tolerated to 20 cm H2O) • Knowledge of selection criteria for NIV Triggers Maximum sensitivity Back up rate 15 breaths/min • Ability to interpret all relevant data (saturation monitor, Back up I:E ratio 1:3 blood gas analysis, etc) • Ability to assess the response to NIV and act accordingly in treatment failure www.thoraxjnl.com
  • 16. Non-invasive ventilation in acute respiratory failure 207 • Knowledge of existing literature on NIV – (7) Presence of peripheral oedema • Practical experience in a centre offering an NIV service – (8) Chest radiographic appearance at this time • An assessment of competency – (9) Prescription of oxygen – (10) Use of ventilatory support The BTS website contains up to date details of courses on NIV – (11) Use of corticosteroids and centres which are able to offer placements for practical experience. – (12) FEV1 • All staff involved in an acute NIV service should receive training – (13) Screening for LTOT appropriate to their baseline knowledge and role in providing the – (14) Smoking cessation advice service. Training in NIV should be available for consultants in – (15) Discharge letter to GP respiratory medicine and should be included in all specialist registrar training programmes. [C] (C) For patients who received NIV • A training programme for the provision of an NIV service should – (16) Previous ventilatory support: invasive/non-invasive provide a combination of knowledge based learning supported by – (17) Arterial blood gas analysis 1 hour after starting NIV: clinical experience in the workplace. [C] whether done, actual values – (18) Arterial blood gas analysis 4–6 hours after starting Audit NIV: whether done, actual values The use of NIV in acute respiratory failure should be the sub- ject of regular audit. This may be performed alongside other – (19) Hours of NIV in first 24 hours related audit activity such as the care of acute COPD – (20) Recorded decision on action to be taken if NIV fails? admissions or augmented care period audit of HDU activity. – (21) Outcome of NIV: subdivide as successful/improved The most important issues, particularly in the early stages of and failure/no benefit. If failure/no benefit, did the setting up an acute NIV service, include the following: patient receive tracheal IPPV? Reason(s) for failure: (a) • Is an acute NIV service available? intolerance of mask, (b) secretions, (c) nasal bridge ero- • Is NIV being used appropriately? sions, (d) other (specify) • Are all patients in whom NIV is indicated being treated? – (22) Outcome of admission • Are patients receiving NIV when they would be better – (23) Length of stay managed by intubation? An example of an audit form, which has been piloted in • Is NIV being used safely? several centres with an established NIV service, is given in appendix 2. • Is the monitoring of patients satisfactory? • The use of NIV in acute respiratory failure should be the subject of • Are plans for escalating treatment in the event of failure regular audit. In addition to collection of data on patients receiving being made? NIV, details of the number of patients admitted with acute • Is NIV being used effectively? hypercapnic respiratory failure will be required, together with the • Is the proportion of patients who succeed with NIV simi- use of invasive ventilation in these patients. [D] lar to other hospitals? Infection control and equipment safety • Are patients being referred appropriately for long term There is no published evidence which addresses infection con- NIV? trol issues specifically in relation to NIV. To date there have been no case reports of nosocomial pneumonia associated In order to answer these questions, the organisation of the with this treatment modality. Nonetheless, equipment used in NIV service and the progress of patients receiving NIV must be delivering NIV may be exposed to potentially infectious mate- audited. In addition, data must be collected on all patients rial during routine use through contact with the patient’s skin, with acute hypercapnic respiratory failure, with more detail mucous membranes, respiratory secretions, and blood. Hospi- on those receiving NIV. The organisational audit might form tal policies to reduce the likelihood of cross infection should be part of a wider audit of respiratory services—for example, the developed in conjunction with local infection control teams. BTS peer review scheme. Since a large proportion of patients While some NIV providers may opt to use single use/ treated will have COPD, background information on all disposable products to reduce risk of cross-contamination, the admissions with acute hypercapnic respiratory failure might costs involved—for example, trying several masks on each be obtained with the BTS COPD audit tool. patient—are likely to be prohibitive for those intent on The following points could be used to provide a framework providing a high level of service. However, items stamped for for audit: single use should not be recycled between patients. (A) Organisational Masks and exhalation valves licensed by the manufacturer – (1) Is NIV available 24 hours per day for patients with as reusable require high level disinfection between patients. acute respiratory failure? They should be disassembled into their component parts before undergoing an automated process employing a – (2) How is it initiated, by whom, and in which clinical combined washer/disinfector/drier using heat at a moderate areas? but effective temperature—for example, the Health Technical – (3) Who is responsible for the service? memorandum HTM2030 cycle which peaks at 87°C for 1 – (4) Are there agreed guidelines for initiating NIV? What minute. Items which are heat sensitive at this temperature are these? How are they disseminated? may be reprocessed using a cycle which reaches 71°C for 3 (B) Process and outcome of patients with acute hypercapnic minutes. Reusable tubing is very difficult to decontaminate respiratory failure secondary to COPD effectively using this method (because of the length and diameter of the lumen) but can be autoclaved at 134°C for 3.5 – (5) Performance status minutes. Headgear and chinstraps should be reprocessed in a – (6) Arterial blood gas analysis on admission (or at time washing machine with a cycle which reaches either 65°C for after admission when respiratory failure developed). 10 minutes or 71°C for 3 minutes. All reprocessed equipment Repeat arterial blood gas analysis within 12 hours of ini- should be inspected for integrity prior to reuse and manufac- tial pH <7.35 (H+ >45 nmol/l) turers’ guidelines should be followed regarding the maximum www.thoraxjnl.com
  • 17. 208 BTS Standards of Care Committee recommended number of cleaning/disinfection cycles for a REFERENCES given item. 1 Ellis E, Bye P, Brudere JW, et al. Treatment of respiratory failure during sleep in patients with neuromuscular disease: positive pressure ventilation In most ventilators used for NIV there is no airflow from the through a nose mask. Am Rev Respir Dis 1987;135:523–4. patient back into the ventilator. Provided a bacterial filter is 2 Kerby G, Mayer L, Pingleton SK. Nocturnal positive pressure ventilation used, the risk of contamination of the ventilator is extremely via nasal mask. Am Rev Respir Dis 1987;135:738–40. 3 Plant PK, Owen JL, Elliott MW. One year period prevalence study of low and superficial cleaning of the ventilator between patients respiratory acidosis in acute exacerbations of COPD: implications for the is satisfactory. Maintenance of ventilators should follow the provision of non-invasive ventilation and oxygen administration. 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  • 20. Non-invasive ventilation in acute respiratory failure 211 APPENDIX 2: Audit record AUDIT RECORD Patient's name: Hospital number: Date of admission: Q1 Sex : Male Female Q2 Date of Birth : Q3 Diagnosis : COPD Chest wall/neuromuscular Obesity/hypoventilation Other: Cardiogenic pulmonary oedema Respiratory failure : Type 1 (hypoxaemic) Type 2 (hypercapnic) Q4 Performance status : Normal activity without restriction Strenuous activity limited, can do light work Limited activity but capable of self care Limited activity, limited self care Confined to bed/chair, no self care No record Q5 Focal consolidation on CXR : Yes No No record Q6 Arterial/capillary blood gases : FiO2 PaO2 PaCO2 pH (or H+) (% or (kPa or (kPa or (units or l/min) mmHg) mmHg) nmol/l) (i) On admission/onset of No record respiratory failure (ii) After 1-2 hours of NIV No record (iii) After 4-6 hours of NIV No record (iv) Pre-discharge No record Q7 Recorded decision on action to be taken if NIV fails : Yes No Q8 Place where NIV initiated : A&E Medical admissions unit HDU ICU Respiratory ward General medical ward Other: Q9 Outcome of NIV : Success/improved Failure/no benefit Tracheal intubation Yes No Reasons for failure: Intolerance of mask Excessive secretions Nasal bridge erosions Other: Q10 Complications of NIV : Q11 FEV1 : Not done . litres % predicted Q12 Outcome of admissions : Discharged from hospital without NIV Discharged from hospital with home NIV Died – likely cause of death respiratory Died – likely cause of death non-respiratory Other: Q15 Length of stay : days Q16 Respiratory OPA arranged: Yes No www.thoraxjnl.com