Conference Proceedings

History and Epidemiology of Noninvasive Ventilation

in the Acute-Care Setting
David J Pierson MD FAARC

Introduction
Evolution of Ventilatory Support in Acute Respiratory Failure
History of Noninvasive Ventilation in the Acute-Care Setting
Epidemiology of Noninvasive Ventilation in the Acute-Care Setting
Noninvasive Ventilation Outside the Setting of Clinical Trials:
Efficacy Versus Effectiveness
Data From Surveys: What Clinicians Say They Do
Data From Observational Studies of Actual NIV Use
Problems With the Accurate Assessment of Current NIV Use
Summary

Although noninvasive ventilation (NIV) was first used to treat patients with acute respiratory
failure in the 1940s, the history of this mainstay of today’s respiratory care armamentarium has
mainly been written in the last 20 years. There is now a robust evidence base documenting the
efficacy of NIV in exacerbations of chronic obstructive pulmonary disease, cardiogenic pulmonary
edema, and acute respiratory failure in immunocompromised patients, and evidence in support of
NIV in other settings, such as hypoxemic acute respiratory failure and the management of patients
who decline endotracheal intubation, is accumulating rapidly. Efficacy as demonstrated in clinical
trials does not necessarily translate to clinical effectiveness in practice, however, and important
barriers need to be overcome if NIV is to realize for the average patient the potential it has shown
in research studies. However, although the expansion of its use in everyday patient care has lagged
behind the growth of its evidence base, an increasing number of studies document the steadily
expanding use of NIV in the acute-care setting. This article reviews the history of NIV as applied
in acutely ill patients and summarizes the studies of NIV outside the research setting during the last
decade. Key words: noninvasive ventilation, NIV, epidemiology, history, clinical practice, acute respi-
ratory failure, chronic obstructive pulmonary disease, COPD, acute care. [Respir Care 2009;54(1):40 –
50. © 2009 Daedalus Enterprises]

Introduction care setting. NIV is now the standard of care in acute

respiratory failure (ARF) due to chronic obstructive pul-
Noninvasive ventilation (NIV) has become a required monary disease (COPD),1-3 evidence is strong for NIV’s
component of the clinician’s armamentarium in the acute- benefits in at least some patients with cardiogenic pul-

David J Pierson MD FAARC is affiliated with the Division of Pulmonary

and Critical Care Medicine, Department of Medicine, Harborview Med-
ical Center, and the University of Washington, Seattle, Washington. The author reports no conflict of interest related to the content of this
paper.
Dr Pierson presented a version of this paper at the 42nd RESPIRATORY
CARE Journal Conference, “Noninvasive Ventilation in Acute Care: Con- Correspondence: David J Pierson MD FAARC, Division of Pulmonary
troversies and Emerging Concepts,” held March 7-9, 2008, in Cancún, and Critical Care Medicine, Harborview Medical Center, 325 Ninth Av-
México. enue, Box 359762, Seattle WA 98104. E-mail: djp@u.washington.edu.

40 RESPIRATORY CARE • JANUARY 2009 VOL 54 NO 1

 HISTORY AND EPIDEMIOLOGY OF NONINVASIVE VENTILATION IN THE ACUTE-CARE SETTING

Table 1. Noninvasive Ventilation in the Acute Care Setting: ble 2). Although supplemental oxygen was used clinically
Clinical Conditions and Strength of Supporting Evidence in a few hospitals in the 1920s, the first feasible means for
sustaining life in patients who were unable to breathe for
Evidence from multiple randomized controlled trials and meta-analyses
Exacerbation of chronic obstructive pulmonary disease
themselves came with the introduction of the tank venti-
Cardiogenic pulmonary edema lator (iron lung) at the end of that decade.25-28 The emer-
Acute respiratory failure in immunocompromised patients gence of mechanical ventilation in its modern sense was
Prevention of weaning failure in high-risk patients spurred by the devastating polio epidemics of the 1950s,
Not effective in established extubation failure when experience in Denmark,29 and subsequently in the
Consistent findings in more than one published clinical trial, case- United States and elsewhere, demonstrated that lives could
control series, or cohort study be saved acutely, and apneic patients supported virtually
Postoperative respiratory failure indefinitely with tracheostomy and positive-pressure ven-
Oxygenation prior to endotracheal intubation
tilation.30-32 Thereafter, once mid-20th century medicine
Support during endoscopy
evolved from a home-based activity to an institution-fo-
Case series or conflicting findings in other types of studies
Acute lung injury and acute respiratory distress syndrome
cused enterprise taking place primarily in hospitals,33 ad-
Extubation failure vances in the understanding of normal and abnormal re-
Acute severe asthma spiratory physiology combined with new devices and other
Pneumonia technology to create the first intensive care units (ICUs),
Acute respiratory failure in patients who do not wish to be intubated whose emergence was driven in large part by the need to
support and monitor ventilation, oxygenation, and airway
(Adapted in part from Reference 10.)
care.
By the early 1970s virtually every American acute-care
hospital had an ICU, and a respiratory therapy department
monary edema,4-6 and a rapidly evolving literature doc- whose members were becoming specialists in invasive me-
uments its use in numerous other clinical settings.7-11 chanical ventilation. Ventilators rapidly became more ca-
Table 1 lists the most prominent of these settings for pable and more sophisticated, with a plethora of new modes
NIV, in relation to the strength of the supporting evi- and other features, whose use was guided by blood gas
dence in each.10 The table refers mainly to the use of analysis and other new ways of physiologic monitoring.
NIV in adult patients, although this therapy is also be- Soon, however, awareness of the complications of inva-
ing used with increasing frequency in infants and chil- sive mechanical ventilation34,35 and artificial airways,36
dren.12-14 To the clinical settings listed under the table’s and subsequently of ventilator-induced lung injury,37,38 led
third category (that is, those supported by the least firm to renewed interest in less aggressive, potentially less in-
evidence at this point) can be added acute neuromus- jurious ventilatory support.
cular disease,15-17 pre-hospital and emergency-depart-
ment use for patients with acute respiratory distress,18-20 History of Noninvasive Ventilation
use during the performance of tracheotomy,21 and acute in the Acute-Care Setting
application in palliative care.22-24
The literature on NIV consists primarily of the results of The application of intermittent positive inspiratory pres-
technical assessments and reports of clinical investigations. sure via an anesthesia mask in the treatment of acute re-
Much less has been written about the extent and nature of spiratory illness was studied by Motley and colleagues at
NIV use in everyday patient care. As the first of the series Bellevue Hospital in the 1940s.39 These clinician-investi-
of reviews developed from the conference, “Noninvasive gators used the apparatus shown in Figure 1 to deliver
Ventilation in Acute Care: Controversies and Emerging intermittent positive-pressure ventilation to patients with
Concepts,” this article first traces the historical develop- pneumonia, pulmonary edema, near-drowning, Guillain-
ment of NIV as an intervention in managing acutely ill Barré syndrome, and acute severe asthma.39 However, this
patients, and then reviews what is known about the clinical approach to life support in the acute-care setting took a
use of this therapy outside the research setting. back seat to invasive mechanical ventilation as the latter
emerged and was refined during the next 2 decades.
Evolution of Ventilatory Support Noninvasive positive-pressure ventilation did not dis-
in Acute Respiratory Failure appear from the scene, however; it found wide use both
in acute-care hospitals and for outpatient treatments in
Noninvasive methods for supporting ventilation have the form of intermittent positive-pressure breathing
featured prominently throughout the history of respiratory (IPPB).40 So widespread did the use of IPPB become by
care, which in turn has been determined in large measure the early 1970s—administered to 10% or more of all
by the need to support the failing respiratory system (Ta- hospitalized patients, with each respiratory therapist typ-

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 HISTORY AND EPIDEMIOLOGY OF NONINVASIVE VENTILATION IN THE ACUTE-CARE SETTING

Table 2. Evolution of Ventilatory Support in the Acute-Care Setting, Particularly With Respect to Noninvasive Ventilation

Pre-1930s
First clinical use of supplemental oxygen in hospitals
No practical means for supporting ventilation
1930s-1940s
Introduction of tank ventilators
Support of apneic patient possible for first time
1950s
Polio epidemics in Europe and United States
Introduction of positive-pressure ventilation via tracheostomy
Development of special cadre of hospital workers for caring for patients with respiratory problems (inhalation therapists)
Use of supplemental oxygen and IPPB in aviation
1960s
Major progress in understanding pulmonary gas exchange
Widespread use of IPPB in United States hospitals for “breathing treatments”
Experience with IPPB in acute respiratory insufficiency
Widespread introduction of volume ventilators
Availability of improved endotracheal tubes
Use of arterial blood gases in patient assessment
First dedicated ICUs
Recognition of ARDS
First use of PEEP to treat hypoxemia in ARDS
1970s
Major progress in understanding lung physiology and pathology
Use of CPAP in neonates
Presence of ICUs in virtually all acute-care hospitals
More sophisticated and capable ICU ventilators
Introduction of intermittent mandatory ventilation and other new ventilation modes
Increasing awareness of complications of invasive mechanical ventilation
Sugarloaf conference; de-emphasis of IPPB
1980s
Increasing focus on respiratory muscle function in acute care settings
Invasive mechanical ventilation as initial approach in virtually all settings of acute respiratory failure
Widespread use of pulse oximetry and other noninvasive respiratory monitoring
Increasing computerization of ventilators and other respiratory care equipment
Introduction of nasal CPAP for treating obstructive sleep apnea
Increasing experience with long-term NPPV in settings other than polio
First reports of use of NPPV in acute hypercapnic respiratory failure in COPD
Introduction of pressure support
Introduction of modern bi-level pressure-targeted ventilators for NPPV
1990s
Increasing reported experience with NPPV in acute-care settings other than COPD
First randomized controlled trials of NPPV in acute respiratory failure
Incorporation of FIO2 control and better monitoring into bi-level ventilators for NPPV
Increasing variety of patient interfaces for NPPV
RESPIRATORY CARE consensus conference on NPPV in the acute care setting
Rapid worldwide dissemination of research findings
Rise of evidence-based medicine
Increasing focus on ventilator-induced lung injury and concept of lung-protective ventilation
Concept of NPPV as bridge to weaning
Ventilator-associated pneumonia and its relationship to intubation
Increased focus on DNAR/DNI and withdrawal of life support
2000s
Rich database on efficacy of NPPV: multiple RCTs; meta-analyses; evidence-based clinical practice guidelines
NPPV as standard of care for COPD exacerbation
Increasing use of NPPV in other settings
Increased focus on DNI and palliative care in the acute-care setting
Increasing focus on knowledge-transfer and addressing the gap between efficacy and effectiveness

IPPB ⫽ intermittent positive-pressure breathing; ICU ⫽ intensive care unit; ARDS ⫽ acute respiratory distress syndrome; PEEP ⫽ positive end-expiratory pressure; CPAP ⫽ continuous positive
airway pressure; NPPV ⫽ noninvasive positive-pressure ventilation; COPD ⫽ chronic obstructive pulmonary disease; FIO2 ⫽ fraction of inspired oxygen; DNAR ⫽ do not attempt resuscitation;
DNI ⫽ do not intubate; RCT ⫽ randomized controlled trial

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 HISTORY AND EPIDEMIOLOGY OF NONINVASIVE VENTILATION IN THE ACUTE-CARE SETTING

Fig. 1. Apparatus used by Motley and associates in the mid-1940s

to deliver intermittent positive-pressure ventilation, with or without Fig. 2. Increasing published experience with noninvasive ventila-
positive end-expiratory pressure, to patients with acute respira- tion in patients with acute respiratory failure, 1989 –1994, as com-
tory failure. A corrugated rubber hose (A) connected a Bendix piled by Sassoon. The majority consisted of patients with chronic
pressure demand regulator (B) to a Bennett Clinical Research obstructive pulmonary disease and patients ventilated postoper-
Model X-2 respirator (C), from which air or oxygen was delivered atively. Numbers above bars indicate total number of patients who
to the patient by means of a Bennett face mask (D). (From Refer- received noninvasive ventilation in each year. (From Reference 60,
ence 39, with permission.) with permission.)

ically giving 150 –200 “treatments” per month,41 at an COPD exacerbations, using both nasal54-57 and full-face
annual cost to the United States health-care system of masks.58,59
more than $400 million42—that the National Institutes The increased use of NIV in the ICU and in other acute-
of Health and the American Thoracic Society convened care settings was facilitated by the introduction of im-
a special conference (the “Sugarloaf Conference”) to proved bi-level ventilators that have effective compensa-
review the issue.43 In large part because of the dearth of tion for air leaks, such as the Respironics BIPAP ST/D,
scientific evidence to support IPPB at that conference, which replaced an earlier home-care model in the early
its use subsequently decreased. 1990s (personal communication, Derek Glinsman RRT
Although it was first tried as early as the 1950s, and was FAARC, Respironics, June 10, 2008). In a 1995 review,
subsequently used in a few centers of special expertise,44 Sassoon summarized the subsequent rapid increase in re-
long-term support of ventilation via NIV only became wide- ported experience with NIV in various forms of ARF
spread starting in the 1980s.45 Continuous positive airway (Fig. 2).60 The years since 1995 have brought an avalanche
pressure (CPAP), delivered via nasal mask to patients with of clinical investigations and other publications on the use
obstructive sleep apnea, had been introduced by Sullivan of NIV in ARF (Fig. 3).10
et al in 1981.46 In 1987 Sullivan’s group reported the As noted in a previous review of the history of NIV, this
successful use of NIV via nasal mask in 3 patients with form of ventilatory support has been called different things
post-infection muscle weakness and 2 with muscular dys- by different researchers, clinicians, and manufacturers,
trophy.47 Several other reports quickly followed and dem- which led to confusion on the part of clinicians and inves-
onstrated that NIV could be effective in various long-term tigators alike.45 To some extent this diversity of terminol-
settings and diagnoses.48-52 ogy persists. However, as familiarity with NIV has in-
Stimulated by the successful application of nasal CPAP creased, the resulting confusion may now be less. The
in sleep apnea, the availability of improved patient inter- term noninvasive positive-pressure ventilation (abbrevi-
faces, an increasing desire to avoid the complications of ated NPPV or NIPPV) was formerly used to distinguish it
invasive mechanical ventilation, and the refusal of some from noninvasive negative-pressure ventilation, although
patients to be intubated, there followed a renewed interest considering the rarity of the latter today, the simpler term
in NIV for managing ARF.45 In 1989, Meduri and col- NIV is more convenient. Because a number of bi-level
leagues reported the successful application of NIV via ventilators are now available for NIV (and also because of
full-face mask in 10 patients, and the avoidance of intu- its use by one European manufacturer of ICU ventilators
bation in 8 of them (4 of 6 with COPD, 2 of 2 with for one of its modes), colloquial use of the term BIPAP (a
congestive heart failure, and 2 of 2 with pneumonia).53 A proprietary product name) as a generic term for NIV should
number of other studies confirmed the efficacy of NIV in be discouraged.

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 HISTORY AND EPIDEMIOLOGY OF NONINVASIVE VENTILATION IN THE ACUTE-CARE SETTING

This has been amply demonstrated with weaning proto-

cols,61,62 other aspects of ventilator management,63 and
other respiratory care64 and acute-care interventions.65,66
As emphasized by several of the other presentations at this
Journal Conference, NIV is as much an art as a science,
with a substantial learning curve and important prerequi-
sites for successful implementation at a particular hospital.
Evidence for the current use of NIV outside the setting
of clinical research comes from 2 kinds of studies: sur-
veys, in which institutions or individual practitioners who
care for patients who are potential candidates for NIV are
queried about their use of it; and observational studies that
document actual utilization in specific clinical settings.
Published evidence available at the time of writing for
each of these contexts is summarized below.
Fig. 3. Increase in the number of articles on noninvasive ventilation
(shaded bars) and in the use of NIV in acute respiratory failure
(white bars) since 1983, based on citations retrieved via PubMed Data From Surveys: What Clinicians Say They Do
as of December 2007. (From Reference 10, with permission.)

Seven studies have characterized the use of NIV in the

Epidemiology of Noninvasive Ventilation acute-care setting, as determined by survey data.23,67-72
in the Acute-Care Setting Table 4 summarizes those studies’ participants, clinical
contexts, patient populations, and main findings, in the
Noninvasive Ventilation Outside the Setting of order in which they were carried out, in the decade be-
Clinical Trials: Efficacy Versus Effectiveness tween 1997 and 2006. Three of these surveys69,70,72 sought
information on all NIV use in acute-care settings, whereas
As indicated in Table 1, evidence supporting the use of 3 others67,68,71 dealt only with the management of COPD
NIV, particularly in some settings, is now plentiful and exacerbations, and one23 was restricted to do-not-intubate
compelling. However, such evidence has been gained pri- patients. Five67-71 sought information on institutional avail-
marily in the context of clinical research rather than from ability and use of NIV, two70,72 queried individual physi-
everyday clinical practice. Both anecdotal observation of cians about their personal practices and attitudes, and one23
NIV use and a large body of literature on other health-care included both physicians and respiratory therapists. One of
interventions suggest that both utilization and outcomes the studies72 surveyed individual physician attitudes and
may be very different in these 2 settings. A main reason is experience rather than the practice of the institutions with
the distinction between efficacy, which is what is demon- which they were affiliated, whereas another study68 dealt
strated under the structured conditions of a clinical study, only with the use of NIV in the emergency department.
and clinical effectiveness, which is what happens in ordi- Figure 4, from the study by Devlin et al,72 shows the
nary, everyday practice (Table 3). frequency of NIV use in different types of ARF, as re-
Regardless of the evidence supporting it in the research ported by 623 North American and European critical-care
setting, for any new procedure or treatment approach to be physicians. The respondents indicated that they used NIV
successfully implemented in an institution, a number of most frequently in patients with obesity hypoventilation
conditions must be met and important barriers overcome. syndrome, COPD exacerbations, and cardiogenic pulmo-

Table 3. Important Distinctions Between Efficacy (as Demonstrated in Clinical Trials) and Clinical Effectiveness (as Experienced in Everyday
Practice)

Efficacy Effectiveness

Results under research conditions Results obtained in real-world, everyday clinical practice
Patients carefully selected Unselected patients
No comorbidities or other interfering problems Many patients have other medical conditions and other problems
that complicate management
Rigidly controlled protocol for management and monitoring Techniques and protocol may or may not match what was done in
the clinical trial
Overseen by investigators and dedicated research staff No special oversight of the intervention

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 Table 4. Reported Results of Surveys About the Use of Noninvasive Ventilation in the Acute-Care Setting

Study When Performed Setting and Response Rate Diagnoses Included Principal Findings Comments

Doherty67 1997 268 British hospitals with respiratory consultants COPD exacerbation NIV available in only 48% of hospitals. Where Marked regional differences in NIV availability
available; in-patient units only. available, used in ⬍ 10 patients/y in 42% of and use. Responding hospitals identified lack of
98% responded hospitals, in ⬎ 60 patients/y in only 7%. training (of physicians in 53%, of other staff in
63%) and financial limitations of acquiring
equipment in 63%, as barriers to NIV
implementation. Most hospitals reported plans
to offer NIV within 2 y.
HISTORY

Vanpee68 2001 145 EDs in Belgium. COPD exacerbation NIV available in only 49% of departments (67% of Among responding EDs, 72% also reported using
68% responded university hospitals, 45% of general hospitals). NIV in cardiogenic pulmonary edema, and 45%
AND

Used in ⬍ 10 patients/y in 37%; in ⬎ 50 in pneumonia. Cited reasons for non-use of NIV

patients/y in 45% of hospitals. were lack of equipment (cost) in 71%, lack of
clinician experience in 33%, and too time-
consuming for physicians and nurses in 22%.

Maheshwari69 2002-2003 RT directors of all 81 acute-care hospitals in All acute applications NIV available in 98% of hospitals. Among Marked variability among responding hospitals in
states of Massachusetts and Rhode Island. ventilated patients, NIV was initially used in NIV use. Larger hospitals and teaching hospitals
88% responded 20%. used NIV more often. NIV initiated in ICU in
56% of respondent hospitals had protocols for 55% of cases, in ED in 26%, and on general
EPIDEMIOLOGY

NIV use. ward in 18%. Most commonly cited barrier to

NIV use was physician lack of knowledge,
OF

followed by inadequate equipment, lack of

previous experience, and inadequate RT
training.

RESPIRATORY CARE • JANUARY 2009 VOL 54 NO 1

Burns70 2003 808 attending and resident physicians at 15 ARF (all causes) 63% of physicians reported using NIV in ARF. Greater use of NIV among respiratory and critical
teaching hospitals in Ontario. 12 of 15 hospitals had protocols, guidelines, or care physicians, by more recently trained
48% responded other NIV policies. physicians, and in hospitals with more
ventilators for NIV.
NIV was used in all hospital areas: most often
in ICU and ED.
COPD and CHF were most common diagnoses
for NIV use..

Sinuff23 2003-2005 Intensivists, pulmonologists, and RTs at 18 DNI and CMO patients only 57% of physicians used NIV at least sometimes in Pulmonologists more likely than intensivists to use
Canadian and 2 United States hospitals. DNI patients with ARF. NIV in DNI patients.
57% of physicians and 61% of RTs responded NIV discussed at least sometimes with DNI Physicians were more likely than RTs to believe
(62%) and CMO (49%) patients. that NIV relieves dyspnea and facilitates
NONINVASIVE VENTILATION

communication in DNI and CMO patients.

Drummond71 2004 All 33 Canadian hospitals with ⬎ 200 beds and COPD exacerbation NIV available at all institutions but standard-of-care Marked regional variability in NIV use.
with pulmonary training programs. in only half. Used “routinely” in 61% (range by region 40–
IN THE

100% responded 70% used NIV only in ED or ICU settings. 100%).

18% used NIV on general wards. In DNI patients, NIV was rarely or never
Used in ⬍ 3 patients/mo in 24% of hospitals, and offered in 32% of hospitals.
⬍ 5 patients/mo in 52% of hospitals.

Devlin72 2006 Cross-sectional Web-based survey of 2,985 All acute applications 44% reported using NIV ⱖ 25% of the time in Marked regional variation in stated use of NIV.
intensivist physicians in ACCP and ERS patients admitted with ARF. Europeans more NIV most likely to be used in COPD
registries. likely than North American physicians to use exacerbation, CHF, and obesity-hypoventilation
27% responded: 41% in Europe, and 19% In NIV in ⱖ 25% of ARF patients (68% vs 37%, syndrome. North American physicians used
North America P ⬍ .01). sedatives (41% vs 24%), analgesics (48% vs
35%), and hand restraints (27% vs 16%) more
often than European physicians (P ⬍ .01 for
each comparison).
ACUTE-CARE SETTING

COPD ⫽ chronic obstructive pulmonary disease CHF ⫽ congestive heart failure

NIV ⫽ noninvasive ventilation DNI ⫽ do not intubate
ED ⫽ emergency department CMO ⫽ comfort measures only
RT ⫽ respiratory therapist ACCP ⫽ American College of Chest Physicians
ICU ⫽ intensive care unit ERS ⫽ European Respiratory Society
ARF ⫽ acute respiratory failure

45
 HISTORY AND EPIDEMIOLOGY OF NONINVASIVE VENTILATION IN THE ACUTE-CARE SETTING

Fig. 4. Reported frequency of noninvasive ventilation (NIV) use in different clinical settings among 790 intensivist physicians from the
American College of Chest Physicians’ Critical Care Network and the European Respiratory Society’s Assembly of Critical Care who
responded to a Web-based survey on sedation practices during NIV for acute respiratory failure. COPD ⫽ chronic obstructive pulmonary
disease. pts ⫽ patients. (From Reference 72, with permission.)

nary edema, and least often in failed extubation and pa- inherent to surveys. They document actual practice in the
tients who do not wish to be intubated. institutions in which they are performed, at least at the
As valuable as surveys can be for indicating awareness, time of the study, for the patients included in the cohort,
access, and attitudes about NIV in the different contexts in and in the clinical setting evaluated. Seven such studies
which it is carried out, a number of shortcomings of such have been published as full peer-reviewed articles,75-81 and
studies should be mentioned.73 The reported results are an eighth was recently reported in abstract form82 (Ta-
taken only from the surveys that were returned (which in ble 5).
the studies summarized in Table 4 ranged from 100% The reported studies differ considerably in design and
down to 27% of those sought), and may not reflect what sample size. Three75,78,79 report single-center cohorts,
the non-responders know, think, or do. Because they re- whereas the rest are multicenter studies, including data
port data from individual practitioners and institutions, from 42 ICUs76 to as many as 361 separate ICUs.77 Two
such surveys may or may not be relevant to other clini- of them80,81 are follow-up studies in which current (or at
cians, in different practice contexts, for different types or least more recent) NIV use is compared to the results of
sizes of institutions, or in other geographic or cultural previous cohorts76,77 from the same groups of investiga-
areas. And, importantly, these studies can only tell us what tors. In 7 of the 8 studies summarized in Table 5 the
the institutions and individuals surveyed say they do, not authors included all acute-care use of NIV in adult pa-
what they actually do. Reported and actual policies and tients, and reported usage rates and outcomes among pa-
practices may be quite different, as has been documented tients with COPD, congestive heart failure, and hypox-
for ventilator charting and other respiratory care practices.74 emic ARF.
In a study aimed at detecting temporal trends in ICU-
Data From Observational Studies of Actual NIV Use related pneumonia and other hospital-acquired infections,
Girou and associates75 tracked NIV use in the management
Observational cohort studies of the use of NIV in the of COPD exacerbations and cardiac pulmonary edema in
acute-care setting get around at least some of the problems their 26-bed medical ICU from 1994 through 2001. As

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 Table 5. Reported Results of Observational Studies of the Use of Noninvasive Ventilation in Acute Care Outside the Setting of Clinical Trials

Study When Performed Setting and Study Design Diagnoses Principal Findings Comments

Girou75 1994–2001 Medical ICU of a French university hospital. COPD exacerbation and CHF Among 479 patients ventilated during the 6-y ICU mortality decreased from 21% in 1994 to 7% in
Retrospective examination of prospectively period, 313 (65%) received NIV, of whom 35 2001. The rate of ICU-acquired pneumonia
collected data on mechanically ventilated (11%) subsequently required intubation. NIV use decreased progressively from 20% to 8% over the
patients. progressively increased as a proportion of all same period. Patients treated with NIV had
patients ventilated during the study period. shorter ICU stay than those who received invasive
ventilation (mean 10 d vs 8 d, P ⫽ .02).

Carlucci76 1997 42 ICUs in France, Switzerland, Belgium, Spain, Hypoxemic ARF (48%), hypercapnic ARF (15%), coma NIV successful (no need for intubation) in 65 Mean duration of NIV was 5.6 d in hypercapnic
HISTORY

and Tunisia. (30%), CHF (7%) (60%) of 108 patients. ARF, 2.4 d in CHF, and 6.3 d in hypoxemic
Prospective study with 3-wk observation period. NIV used in 50% of patients with hypercapnic ARF. Mean hours of NIV per day was ⬍ 9 h at
NIV used as initial ventilation approach in 108 ARF, 27% with CHF, 14% with hypoxemic all times in all groups.
(16%) of 689 patients. ARF, and 0% with coma.
AND

Esteban77 1998 361 ICUs in 20 countries. Hypoxemic ARF (69%, including CHF 10%), coma 85 COPD patients received NIV, of whom 22 Mortality in COPD patients was 14% when NIV was
Prospective cohort study of adult patients (17%), COPD exacerbation (10%) (26%) were subsequently intubated. successful and 42% when intubation was
ventilated for ⬎ 12 h during a 28-d period. NIV 54 (36%) of 148 patients with hypoxemic ARF subsequently required. In other patients treated
used as initial ventilation approach in 256 who received NIV were subsequently intubated. initially with NIV, mortality was higher if
(4.9%) of 5,183 patients. intubation was required, compared to patients
initially intubated (48% vs 31%).

Paus-Jenssen78 2001 Prospective cohort study of all NIV use in a Shortness of breath (24%), COPD exacerbation (17%), NIV initiated in ED (32%), ICU (27%), ward Study hospital had no NIV protocol or policy other
Canadian teaching hospital over a 5-mo period. hypoxemic ARF (17%), CHF (13%), other (29%) observation unit (23%), or general medical ward than requiring a physician’s order.
EPIDEMIOLOGY

75 patients were included: 64 NIV, 11 CPAP (18%). Study data were recorded by the RTs who
only. 13% of patients required intubation and 24% provided the care.
OF

died (16% with DNAR status).

Schettino79 2001 Prospective cohort study in teaching hospital of All adult patients who received NIV or CPAP for an 458 episodes in 449 patients. NIV initiated in ICU 53% of patients were managed in an ICU after NIV
NIV use during 1-y period acute indication anywhere in the hospital. DNI patients in 47%, on general medical ward in 33%, in ED initiation, 35% in general medical-surgical wards,
excluded. Hypoxemic ARF (60%), post-extubation in 20%. and 12% exclusively in the ED.

RESPIRATORY CARE • JANUARY 2009 VOL 54 NO 1

ARF (40%), hypercapnic ARF non-COPD (38%), Overall mortality 21% (47% when NIV was RT/patient ratio 1.6:1.8 and nurse/patient ratio
COPD exacerbation (24%), CHF (18%) unsuccessful and intubation was carried out). 1.4:1.6 outside the ICU setting. Of the 97 patients
49% of NIV patients managed in an ICU were with CHF, 60% were managed with CPAP alone,
subsequently intubated, vs 27% on the general and only 18% of them required intubation; most
ward. of them were managed in the ED without
admission to the ICU.

Demoule80 2002 Follow-up study 5 y after 1997 cohort.76 All adult patients ventilated in ICU. Hypoxemic ARF Of 1,076 patients ventilated, 249 (23%) received The proportion of all patients who received
Observational cohort study of all ventilated (42%), acute-on-chronic respiratory failure (16%: NIV as initial support, compared to 16% in 1997 ventilator support who had NIV successfully
patients in 70 French ICUs (32 university, 38 COPD 11%, restrictive disease 5%), coma (34%), CHF cohort. In patients not intubated prior to applied without the need for intubation increased
non-university; 28 were also in 1997 study) (8%). admission, NIV was used in 52%, vs 35% in from 9% to 13%, compared to the 1997 cohort.
over a 3-wk period. 1997.
38% of NIV patients subsequently required
intubation.
NONINVASIVE VENTILATION

Esteban81 2004 Follow-up study of 1998 cohort.77 All adult patients ventilated in ICU for ⬎ 12 h. 4,968 patients were included, of whom 1,675 were Neither the requirement for intubation (35%) nor
1-mo observational cohort study of all patients Hypoxemic ARF (72%, including CHF 6%), coma managed in 107 ICUs that also participated in mortality (24%) was different in the 2004 cohort,
ventilated in 349 ICUs in 23 countries. (19%), COPD exacerbation (5%). the 1998 study. compared to the patients studied in 1998.
11% of ventilated patients received NIV, vs 4%
IN THE

in 1998.
NIV was used in 48 of 109 patients with COPD
and in 109 of 1,083 patients with primary ARF:
each proportion significantly more than in the
1998 cohort.

Orzsancak82 2007 Survey of NIV practice in 8 “low-utilization” All acute applications of NIV in adults. COPD (25%), 244 (42%) of 581 patients begun on mechanical Reported only in abstract form as of the time of this
hospitals in Massachusetts and Rhode Island, as CHF (26%), pneumonia (18%), other (31%). ventilation received NIV. writing.
identified in previous survey.69 Excluding patients who were intubated for
Prospective 1-mo cohort study. airway protection, NIV was initial approach in
81% of COPD patients, 73% with CHF, 49%
with pneumonia, and 66% in other causes of
ARF.
Overall success rate with NIV was 71%, and
mortality was 16%.
ACUTE-CARE SETTING

ICU ⫽ intensive care unit DNI ⫽ do not intubate

COPD ⫽ chronic obstructive pulmonary disease ED ⫽ emergency department
CHF ⫽ congestive heart failure DNAR ⫽ do not attempt resuscitation
NIV ⫽ noninvasive ventilation RT ⫽ respiratory therapist
ARF ⫽ acute respiratory failure CPAP ⫽ continuous positive airway pressure

47
 HISTORY AND EPIDEMIOLOGY OF NONINVASIVE VENTILATION IN THE ACUTE-CARE SETTING

tilators for NIV, operated by their institution in France.

During the observation period, out-of-hospital NIV was
attempted in 138 patients with congestive heart failure
(56%), COPD exacerbation (28%), or primary ARF (16%).
NIV was deemed successful (ie, intubation was not re-
quired either in the field or in the emergency department)
in 102 patients (74%). Patients with congestive heart fail-
ure were more likely to be managed successfully with
NIV, and major air leaks that signified inability to achieve
a satisfactory mask seal predicted subsequent need for
intubation. As of the time of this writing, no other reports
of NIV use in pre-hospital emergency care have been pub-
Fig. 5. Increasing use of noninvasive ventilation, as a proportion of lished.
all uses of mechanical ventilation, in the management of 479 pa-
tients with exacerbations of chronic obstructive pulmonary dis-
ease or acute cardiogenic pulmonary edema during a 6-year pe-
Problems With the Accurate
riod in the 26-bed intensive care unit of a French university hospital. Assessment of Current NIV Use
The vertical lines represent the 95% confidence limits. (From Ref-
erence 75, with permission.)
Although they are designated as evaluations of practice
“outside the research setting,” the studies summarized here
all involved the collection of data in “real time” in all
instances of NIV use. Thus, the practices documented were,
to a degree, observed in a research setting. However, ex-
cept for investigations that involved large administrative
databases, which are necessarily limited in what they can
reveal about institutional practice and clinician behavior,
this approach to studying current NIV use is probably the
only practical way to address the issue.
The epidemiology of NIV use in the acute-care setting
is, however, a moving target. Although, as in other areas
of medicine, practice appears to have lagged behind the
Fig. 6. Proportions of 449 patients, in a cohort of acute-care pa-
evidence base by several years, it is apparent that NIV is
tients who received noninvasive ventilation in a major teaching
hospital, who required intubation (black bars) and, once intubated, being used by more and more clinicians and is now avail-
the proportion who died (white bars), in different diagnostic groups. able in most if not all acute-care institutions. Assessment
COPD ⫽ chronic obstructive pulmonary disease. (From Refer- of historical trends and current use has been complicated
ence 79, with permission.) by different definitions of NIV (eg, the inclusion of CPAP
in some studies), the variety of locations in which NIV has
been used (eg, ICU vs general ward vs emergency depart-
shown in Figure 5, NIV use, as a proportion of all patients
ment), the sometimes vague criteria for patient inclusion,
with these diagnoses who received mechanical ventilation
the definitions of NIV success and failure, and the unclear
in the unit, increased steadily throughout that period.
denominators from which included patients were drawn in
Schettino et al79 prospectively documented non-inves-
some series.
tigational NIV use during the year 2001 in a large teaching
hospital with extensive experience with this therapy. They
excluded do-not-intubate patients but included all other Summary
applications of NIV in patients ⱖ 18 y old, in all areas of
the hospital. Figure 6 shows the outcomes of the patients Since the 1940s, NIV has evolved in parallel with in-
in 5 different diagnostic categories. The rates of NIV fail- vasive mechanical ventilation in the care of patients with
ure (that is, the need to intubate and invasively ventilate) ARF. With the explosion of reported studies on NIV use in
and fatal outcome among patients who failed NIV differed different patient populations and clinical contexts in the
considerably in the patient categories. last 20 years has come a steady (if belated) increase in the
In a study not summarized in Table 5, Bruge et al18 use of this therapy in everyday practice. Although they
recently reported the results of a 2-year prospective ob- probably do not reflect the dimensions of practice in 2009
servational investigation of NIV in pre-hospital care, in very accurately, numerous studies of reported and actual
emergency-response vehicles equipped with bi-level ven- NIV use in acute-care settings show that this modality is

48 RESPIRATORY CARE • JANUARY 2009 VOL 54 NO 1

 HISTORY AND EPIDEMIOLOGY OF NONINVASIVE VENTILATION IN THE ACUTE-CARE SETTING

now widely available and routinely used by increasing 23. Sinuff T, Cook DJ, Keenan SP, Burns KEA, Adhikari NKJ, Rocker
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the end of life. Crit Care Med 2008;36(3):789-794.
24. Curtis JR, Cook DJ, Sinuff T, White DB, Hill N, Keenan SP, et al.
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Discussion the patient’s ability to protect the air- Hill: I think I’m hearing less of that,
way and clear secretions, the patient’s Bob, than I did, say, half a dozen years
Hill: You alluded to the difficulty mental status, and so forth. Our goal ago.
in getting accurate information on this shouldn’t just be to have the largest
topic, and I entirely concur, having possible number of patients who have Kacmarek: I agree.
done some of the work that you pre- respiratory problems getting NIV.
sented. One of the problems is that Sean Keenan’s group published a Hill: I think we’re moving in the
many of these studies, including our study1 in RESPIRATORY CARE a few years direction of using it more. My group
own, relied on questionnaires and ago in which they looked at NIV in is trying to get at the issue of appro-
lacked validation. Also, very few of mild exacerbations of COPD and priate utilization. Is it being used when
the studies defined how the types of found that (1) NIV didn’t seem to have it’s supposed to be used, and not be-
respiratory failure were diagnosed. any benefit over standard therapy, and ing used when it shouldn’t? Ideally
We’ve been doing follow-up work (2) they couldn’t get them to do it we want to optimize utilization, not
on-site—not relying on question- anyway. So I think it’s an oversimpli- just increase utilization. That’s a dif-
naires, but documenting actual NIV fication to say that we should just sim- ficult issue to get at because when it’s
utilization. And one of the challenges ply increase the number or proportion used is a judgment call, and unless
is defining the target population. There of patients with acute respiratory prob- you’re right there at the bedside it can
are patients who go on mechanical ven- lems who are administered NIV. be very hard to know in “gray area”
tilation because of procedures, sur- cases whether NIV is appropriate. But
1. Keenan SP, Powers CE, McCormack DG.
gery, or general anesthesia, who are at least we will be able to pick up
Noninvasive positive-pressure ventilation
not relevant to what we’re talking in patients with milder chronic obstructive gross outliers, and we haven’t gone
about. And there are patients who get pulmonary disease exacerbations: a ran- through the data on that, but we’re
intubated for airway protection, who domized controlled trial. Respir Care 2005; addressing it.
are comatose or have severe swallow- 50(5):610-616.
ing or secretion problems and should Benditt: At our hospital one of the
not be on NIV in any case. Epstein: You both have good points. hardest things has been to convince
We looked at the hospitals that were Do we use NIV when it should be the emergency-department physicians
low NIV utilizers—less than 15% of used? Do we use it when it should not that NIV is effective. I would say that
the initial ventilator starts were with be used? And when we use it in the most of the appropriate NIV starts are
NIV in the Maheshwari et al1 survey correct patient, do we use it correctly? in the emergency department, for
in early 2003, but now NIV is being To create a quality NIV program those COPD, where the effect seems to be
used in more than 50% of initial ven- are important questions. Do we have greatest. We’ve started a liaison be-
tilator starts. I think we’re seeing more any data on whether NIV is being used tween our respiratory care department
acceptance of NIV over the last half- in the right patients and with the right and our emergency department, with
a-dozen years. I don’t think the stud- settings? teaching sessions and so forth to try to
ies you showed are up-to-date enough increase early use of NIV. One of the
to reflect that trend. Parenthetically, I major stumbling blocks is that maybe
think the Europeans were ahead of the Kacmarek: Clearly we do not have the pulmonologists and the intensiv-
North Americans on this, but the North those data. We did not get into the ists are thinking about it, but maybe
Americans are catching up. “whys and wherefores” of not using we are looking in the wrong place.
NIV; Dave simply looked at NIV uti-
1. Maheshwari V, Paioli D, Rothaar R, Hill
lization. I still run into practitioners Pierson: Josh, you and I both prac-
NS. Utilization of noninvasive ventilation
in acute care hospitals: a regional survey. who say they rarely do NIV. NIV has tice in Seattle, which is world-
Chest 2006;129(5):1226-1233. become a more refined technique in renowned for its Medic One system.
the institutions that use it frequently. Not only do I agree that in the emer-
Pierson: Your point is a good one. It’s a learned process that requires a gency department it’s very important
The goal is not necessarily to increase lot of to use the right decision-making, but,
NIV use in and of itself. There has “art” in addition to science to be suc- also, increasingly, outside the hospital
been a disturbing tendency in some of cessful. Unless you’re really lucky in pre-hospital conditions. I’ve heard
the units in which I attend that any while initiating an NIV program, the it said that Seattle is an ideal place to
patient who develops an acute respi- whole process can take on a negative have a catastrophic event out on the
ratory problem is immediately slapped tone in an institution, and early fail- street, but it’s not a very good place to
on NIV, without as much consider- ures can adversely affect the future experience a simple faint, because if
ation as perhaps there should be about use of NIV at any institution. you do, you’re going to wind up in-

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 HISTORY AND EPIDEMIOLOGY OF NONINVASIVE VENTILATION IN THE ACUTE-CARE SETTING

tubated and in the emergency depart- 3. Maheshwari V, Paioli D, Rothaar R, Hill expect the residents or average clini-
ment at Harborview! Many of our pa- NS. Utilization of noninvasive ventilation cian to be comfortable with this. In
in acute care hospitals: a regional survey.
tients who are said to have had acute Chest 2006;129(5):1226-1233.
my hospital the people who are most
respiratory distress, when they first en- comfortable and have the expertise
ter the emergency department, are al- Hess: Addressing the international with NIV are the respiratory therapists,
ready intubated. aspects of NIV, I’ll share an anecdote. and they are present everywhere, in-
Some time ago I was at a conference cluding in the emergency department
Nava: Timing is important, espe- in Southeast Asia. I gave a lecture on when patients arrive. Maybe they
cially when you take into consider- NIV and how to initiate NIV in a hos- should be the group leading NIV use
ation the epidemiology of NIV. An- pital. A physician came up to me after in many institutions?
drés Esteban found that COPD that lecture and said that in his coun-
admission to the ICU dropped from try he was certain there had never been Doyle:* In the surveys on NIV and
10% to 5% in the last 6 years.1 COPD a single use of NIV. CPAP did they survey any neonatal
exacerbations did not decrease, so that groups? It seems to me that a lot of
means that most of the patients were Mehta: We in this room, and oth- neonatal patients are not being intu-
treated outside the ICU. And most of ers, are responsible for making the bated, but instead are placed on what
the surveys were performed in the field of NIV overwhelming for many I would call high-flow systems. Are
ICUs, including those by Demoule,2 practitioners. There have been numer- those included in the surveys’ defini-
Esteban,1 and Hill.3 It’s important to ous trials in the last 10 years, and we tions of NIV? It also appears to me
understand where and how we treat can’t expect the average clinician to there’s a proliferation of use of high-
those patients—not only in the ICU. be aware of all those trials. So the flow (30-40 L/min) oxygen nasal-
In North America it’s a bit different, goal of having all physicians, respira- prongs systems in adult patients, which
and Nick pointed out the difference tory therapists, and institutions famil- I suspect deliver some level of CPAP.
between Europe and the States. In Eu- iar and comfortable with NIV may be Are such high-flow oxygen system in-
rope we do a lot more NIV than they overly ambitious. And I’m not sure cluded in the definitions of NIV?
do in North America, including out- that we should be encouraging every
side the ICU, in the emergency de- single clinician to be comfortable with Pierson: In my literature search,
partment and pulmonology ward, NIV, in that I think it might be dan- without any restriction on patient age,
which is not an ICU. I think NIV is gerous. nothing popped up on any of the in-
more popular in Europe because we We know that there are certain pa- quiries with respect to the neonatal
have 2 big fields of application, de- tients we can harm by using NIV too and pediatric populations. The first
pending on timing. long, starting it too late, or delaying NIV support of acute respiratory fail-
necessary intubation. Over the last year ure probably was in neonates—at least
1. Esteban A, Ferguson ND, Meade MO, Fru- one of the early instances I heard about
tos-Vivar F, Apezteguia C, Brochard L, we’ve started outreach “access” teams
throughout most of Canada—it’s be- was— but I am not aware of any or-
et al. Evolution of mechanical ventilation
in response to clinical research. Am J Re- come a government mandate—to have ganized documentation of what the
spir Crit Care Med 2008;177(2):170-177. a dedicated team in the hospital who practice has been.
2. Demoule A, Girou E, Richard JC, Taillé S,
are extremely comfortable with NIV.
Brochard L. Increased use of noninvasive
ventilation in French intensive care units. Also, the number of types of ven-
Intensive Care Med 2006;32(11):1747- tilators and masks and modes is over- * Peter Doyle RRT, Respironics, Carlsbad, Cal-
1755. whelming. And I don’t think we can ifornia.

52 RESPIRATORY CARE • JANUARY 2009 VOL 54 NO 1