Background In patients with acute exacerbations of chronic obstructivepulmonary disease, noninvasive ventilation may be used in anattempt to avoid endotracheal intubation and complications associatedwith mechanical ventilation.
Methods We conducted a prospective, randomized study comparingnoninvasive pressure-support ventilation delivered through aface mask with standard treatment in patients admitted to fiveintensive care units over a 15-month period.
Results A total of 85 patients were recruited from a largergroup of 275 patients with chronic obstructive pulmonary diseaseadmitted to the intensive care units in the same period. A totalof 42 were randomly assigned to standard therapy and 43 to noninvasiveventilation. The two groups had similar clinical characteristicson admission to the hospital. The use of noninvasive ventilationsignificantly reduced the need for endotracheal intubation (whichwas dictated by objective criteria): 11 of 43 patients (26 percent)in the noninvasive-ventilation group were intubated, as comparedwith 31 of 42 (74 percent) in the standard-treatment group (P<0.001).In addition, the frequency of complications was significantlylower in the noninvasive-ventilation group (16 percent vs. 48percent, P = 0.001), and the mean (±SD) hospital staywas significantly shorter for patients receiving noninvasiveventilation (23±17 days vs. 35±33 days, P = 0.005).The in-hospital mortality rate was also significantly reducedwith noninvasive ventilation (4 of 43 patients, or 9 percent,in the noninvasive-ventilation group died in the hospital, ascompared with 12 of 42, or 29 percent, in the standard-treatmentgroup; P = 0.02).
Conclusions In selected patients with acute exacerbations ofchronic obstructive pulmonary disease, noninvasive ventilationcan reduce the need for endotracheal intubation, the lengthof the hospital stay, and the in-hospital mortality rate.
Endotracheal intubation and mechanical ventilation can be alife-saving procedure. However, the use of artificial airwaysmay lead to infectious complications and injury to the trachea.1,2,3Noninvasive ventilation is an alternative approach that wasdeveloped to avoid these complications in patients with acuterespiratory failure.4,5,6,7,8,9 It is often used for acute exacerbationsof chronic obstructive pulmonary disease, because such exacerbationsmay be rapidly reversed and because the hypercapnic ventilatoryfailure that occurs in patients with this disorder seems torespond well to noninvasive ventilation.8,10,11,12,13,14,15,16
Most studies of noninvasive ventilation in patients with acuterespiratory failure have not been randomized.5,7,8,12,13,14,15The results of our previous case–control study suggestthat this approach can reduce the need for endotracheal intubationand the length of the hospital stay.6 One recent prospective,randomized study reported a reduction in mortality with theuse of nasal ventilation in patients with chronic obstructivepulmonary disease, when patients who could not tolerate theprocedure were excluded from the comparison.16 However, thepotential benefits of noninvasive ventilation in terms of reducedmorbidity, mortality, and hospitalization have not been fullydelineated.17 Such data are particularly important in view ofthe practical and technical difficulties that may be encounteredwith this new form of therapy.18
We conducted a multicenter, prospective, randomized trial tocompare the efficacy of noninvasive ventilation, delivered througha face mask, with standard medical treatment, in patients admittedbecause of acute exacerbations of chronic obstructive pulmonarydisease.
Methods
Between September 1990 and November 1991, adult patients hospitalizedbecause of acute exacerbations of chronic obstructive pulmonarydisease were prospectively recruited from five hospitals: HenriMondor Hospital, Antoine Béclère Hospital, andInternational Hospital of the University of Paris in France,La Sapienza University Hospital in Italy, and Sant Pau Hospitalin Spain. The study protocol was approved by the ethics committeeof Henri Mondor Hospital, and patients or their relatives gaveinformed consent.
Patients enrolled in the study had known chronic obstructivepulmonary disease or a high probability of the disease (on thebasis of the clinical history, physical examination, and chestfilm), with respiratory acidosis and an elevated bicarbonatelevel. Additional criteria for enrollment included an exacerbationof dyspnea lasting less than two weeks and at least two of thefollowing: a respiratory rate above 30 breaths per minute, apartial pressure of arterial oxygen below 45 mm Hg, and an arterialpH below 7.35 after the patient had been breathing room airfor at least 10 minutes.
The criteria for exclusion were a respiratory rate below 12breaths per minute or the need for immediate intubation (asdefined below); a tracheotomy or endotracheal intubation performedbefore admission; the administration of sedative drugs withinthe previous 12 hours; a central nervous system disorder unrelatedto hypercapnic encephalopathy or hypoxemia; cardiac arrest (withinthe previous five days); cardiogenic pulmonary edema; kyphoscoliosisas the cause of chronic respiratory failure or a neuromusculardisorder; upper airway obstruction or asthma; a clear causeof decompensation requiring specific treatment (e.g., peritonitis,septic shock, acute myocardial infarction, pulmonary thromboembolism,pneumothorax, hemoptysis, severe pneumonia, or recent surgeryor trauma); a facial deformity; or enrollment in other investigativeprotocols. In addition, patients who refused to undergo endotrachealintubation, whatever the initial therapeutic approach, wereexcluded from the study.
Patients were randomly assigned to receive either standard treatmentor standard treatment plus pressure-support ventilation througha face mask. Random assignments were made with sealed envelopes.
Standard Treatment
Patients assigned to the standard-treatment group received oxygenlimited to a maximal flow rate of 5 liters per minute, by meansof nasal prongs, in order to achieve a level of arterial oxygensaturation above 90 percent. Medications included subcutaneousheparin, antibiotic agents, and bronchodilators (subcutaneousterbutaline, aerosolized and intravenous albuterol, and corticosteroidsor intravenous aminophylline or both), with the correction ofelectrolyte abnormalities.
Noninvasive Ventilation
Patients assigned to the noninvasive-ventilation group receivedthe same medications as the patients in the standard-treatmentgroup, with the addition of periods of noninvasive ventilation.All the participating centers used the same apparatus to delivernoninvasive pressure-support ventilation (ARM 25, Taema, Antony,France), which works on the principle of air entrainment.19The apparatus is triggered by air flow and maintains a constantpressure during inspiration, with a rapid pressurization rate.It is cycled from inspiration to expiration according to theflow signal and can be adjusted at a rate between 10 and 35liters per minute to compensate for leaks. Pressure supportwas initially adjusted at a level of 20 cm of water.6,20,21In the case of leaks, lower levels were used. Expiratory pressurewas atmospheric. Oxygen was administered to provide an arterialoxygen saturation above 90 percent. In case of apnea, the machineprovided automatic pressure-controlled cycles. A face mask wasdeveloped for use in the study (Figure 1).
Figure 1. Photograph of the Face Mask Used to Deliver Noninvasive Ventilation.
The white piece of foam was placed inside the mask to reduce the amount of internal dead space.
Patients underwent noninvasive ventilation for at least sixhours each day. The period could be lengthened, depending onthe clinical tolerance of the patients. Each day, however, patientswere allowed to breathe spontaneously, with oxygen but withoutassistance, for two hours. The overall duration of noninvasiveventilation was determined on the basis of clinical criteriaand arterial-blood gas levels; in each case, the decision wasmade by the physician in charge.
Criteria for Intubation
To make the decision whether to perform endotracheal intubationas objective as possible, we established criteria based on theclinical experience of the participating physicians and on reporteddata.11,22 The major criteria included respiratory arrest, respiratorypauses with loss of consciousness or gasping for air, psychomotoragitation making nursing care impossible and requiring sedation,a heart rate below 50 beats per minute with loss of alertness,and hemodynamic instability with systolic arterial blood pressurebelow 70 mm Hg. Minor criteria were a respiratory rate above35 breaths per minute and above the value on admission; an arterialpH value below 7.30 and below the value on admission; a valuefor the partial pressure of arterial oxygen below 45 mm Hg,despite oxygen therapy; and an increase in the score for encephalopathy(0, normal; 1, mild asterixis; 2, marked asterixis, mild confusion,or sleepiness during the day; 3, major confusion with daytimesleepiness or agitation; and 4, obtundation or major agitation).In both groups, the presence of one major criterion was consideredto indicate the need for intubation and mechanical ventilation,and after the first hour of treatment, the presence of two minorcriteria was considered to indicate the need for intubation.In the noninvasive-ventilation group, however, if a criterionwas present after the withdrawal of ventilatory support, itcould be reintroduced. If the criterion persisted after ventilationhad been resumed, intubation was performed. Patients who neededendotracheal intubation were mechanically ventilated in theassist-control mode and were weaned with the pressure-supportmode.23
Follow-Up
The respiratory rate, encephalopathy score, and arterial-bloodgas levels were determined 1, 3, and 12 hours after the startof treatment. On subsequent days in the intensive care unit,these data were obtained once daily. The simplified acute physiologicscore was calculated at 24 hours.24 Pulmonary-function testingwas performed before discharge, when possible, or within threemonths after discharge.
Statistical Analysis
The primary outcome variable was the need for endotracheal intubationand mechanical ventilation at any time during the study. Secondaryend points were the length of the hospital stay, complicationsnot present on admission (such as pneumonia, barotrauma, gastrointestinalhemorrhage, renal insufficiency, neurologic events, and pulmonaryembolism), the duration of ventilatory assistance, and the mortalityrate during hospitalization.
Results are given as means ±SD. All tests and P valuesare two-tailed. The group means were compared with the t-test.Multiple comparisons were performed with an analysis of variancefor repeated measures, and pairwise comparisons were performedwith Fisher's exact test. Qualitative data were compared withthe chi-square test. To determine whether endotracheal intubationhad a significant influence on mortality, the extended Mantel–Haenszeltest was used.25 A P value of less than 0.05 was consideredto indicate statistical significance. The BMDP statistical softwarepackage was used.
Results
Characteristics of the Patients
Of the 275 patients admitted to the participating hospitalswith acute or chronic respiratory failure during the study period,85 were enrolled in the study; 190 (69 percent) were not included(27 percent were already undergoing mechanical ventilation orrequired immediate endotracheal intubation, 17 percent had leftheart failure, 9 percent had pneumonia or sepsis, 8 percentwere in the perioperative period, 6 percent had asthma, and34 percent were excluded for various other reasons).
Forty-two patients were randomly assigned to standard treatment,and 43 to noninvasive ventilation. The two groups had similarcharacteristics on admission (Table 1). Ten patients (24 percent)in the standard-treatment group and 12 (28 percent) in the noninvasive-ventilationgroup had previously been mechanically ventilated for a similarepisode. The same medications were administered in the two groups(antibiotic agents were given to 32 patients in the standard-treatmentgroup and 27 in the noninvasive-ventilation group; inhaled orintravenous sympathomimetic agents to 30 and 29 patients inthe two groups, respectively; corticosteroids to 24 and 26 patients;diuretic agents to 17 and 24 patients; and aminophylline to24 and 26 patients).
Table 1. Characteristics of Patients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease Assigned to Standard Treatment or Noninvasive Ventilation, at Admission and after One Hour of Therapy.
Clinical Outcomes
Thirty-one of the 42 patients (74 percent) in the standard-treatmentgroup required endotracheal intubation, as compared with only11 of the 43 patients (26 percent) in the noninvasive-ventilationgroup (P<0.001). The results were consistent among the fiveparticipating centers (Table 2).
Table 2. Patients Requiring Endotracheal Intubation after Assignment to Standard Treatment or Noninvasive Ventilation, According to the Participating Center.
The time at which intubation was performed is shown in Figure 2.Twenty-three of 31 patients (74 percent) in the standard-treatmentgroup required intubation within the first 12 hours, as comparedwith 9 of 11 patients (82 percent) in the noninvasive-ventilationgroup. Endotracheal intubation was indicated because of thepresence of major criteria in 10 of the 31 patients intubated(32 percent) in the standard-treatment group and in 8 of the11 (73 percent) in the noninvasive-ventilation group. Of thefour patients in whom noninvasive ventilation was withdrawnand then resumed because of the presence of at least two minorcriteria, three were intubated because the criteria persisted.
Figure 2. The Time at Which Endotracheal Intubation Was Performed in the Two Treatment Groups.
A total of 17 patients required intubation after the first hour in the standard-treatment group, as compared with only 3 patients in the noninvasive-ventilation group.
There was a significant improvement in the encephalopathy score,respiratory rate, partial pressure of arterial oxygen, and pHduring the first hour of treatment in the noninvasive-ventilationgroup, whereas there was a significant deterioration in theencephalopathy score, partial pressure of arterial carbon dioxide,and pH in the standard-treatment group (Table 1).
Table 3 shows the characteristics at enrollment, length of hospitalization,and number of deaths, according to whether endotracheal intubationwas required. Subgroup differences were noted in the simplifiedacute physiologic score and the encephalopathy score. In thesubgroup successfully treated with noninvasive ventilation,a significant improvement was noted in the respiratory rate(34±7 breaths per minute at base line, 24±8 at1 hour, 25±7 at 3 hours, and 25±5 at 12 hours),as well as in the partial pressure of arterial oxygen at 1 hourand the partial pressure of arterial carbon dioxide at 12 hours(Figure 3) (P<0.001 for all comparisons). The encephalopathyscore dropped from 1.6±1.3 at base line and 1.3±1.2at 1 hour to 1.1±1.1 at 3 hours and 0.8±1.0 at12 hours (P<0.001).
Table 3. Characteristics at Admission and Mortality Rate, According to Whether Endotracheal Intubation Was Required after Assignment to Standard Treatment or Noninvasive Ventilation.
Figure 3. Mean (±SE) Values for the Partial Pressure of Arterial Oxygen (PaO2) and Carbon Dioxide (PaCO2) during the First 12 Hours in the 32 Patients Successfully Treated with Noninvasive Ventilation.
The P values are for the comparison with the base-line values.
In the standard-treatment group, the 31 patients who requiredendotracheal intubation were ventilated for a total of 17±21days. In the noninvasive-ventilation group, the 11 patientswho underwent endotracheal intubation were intubated for a totalof 25±17 days; the other 32 patients were ventilatedwith a face mask for a mean of 4±4 days.
Complications and events leading to death are shown in Table 4.The proportion of patients with one or more complicationswas significantly higher in the standard-treatment group (20of 42 patients, or 48 percent) than in the noninvasive-ventilationgroup (7 of 43, or 16 percent; P = 0.001). The proportion ofpatients who died in the hospital was also significantly higherin the standard-treatment group (12 of 42 patients, or 29 percent,vs. 4 of 43, or 9 percent; P = 0.02). Ten of the 12 deaths inthe standard-treatment group and 3 of the 4 in the noninvasive-ventilationgroup occurred during mechanical ventilation.
Table 4. Complications and Lethal Events in the Two Treatment Groups.
Since the numbers of patients requiring intubation were differentin the two groups, we compared mortality rates after adjustmentfor endotracheal intubation, using the Mantel–Haenszeltest. After adjustment, we found no significant difference,suggesting that the number of patients requiring intubationwas the main factor explaining the difference in mortality.
Reliable pulmonary-function data were obtained within threemonths after randomization in 23 of the patients in the standard-treatmentgroup and in 24 of those in the noninvasive-ventilation group.The forced expiratory volume in one second (0.68±0.19liter, or 28±10 percent of the predicted value, in thestandard-treatment group, and 0.72±0.21, or 31±8percent, in the noninvasive-ventilation group), the vital capacity(1.48±0.58 liters, or 42±13 percent of the predictedvalue, and 1.28±0.46 liters, or 43±10 percent,respectively), and the ratio of the two measures (51±16percent and 57±17 percent, respectively) were similarin the two groups.
Hospital Stay
The hospital stay was significantly longer in the group receivingstandard treatment (35±33 days) than in the group receivingnoninvasive ventilation (23±17 days, P = 0.02). Figure 4shows the length of the hospital stay in the two groups.
Figure 4. The Length of the Hospital Stay among the Surviving Patients in the Two Treatment Groups.
Seven of the patients (18 percent) in the noninvasive-ventilation group stayed in the hospital for more than four weeks, as compared with 14 (47 percent) in the standard-treatment group (P = 0.004).
Discussion
This study shows that the use of noninvasive ventilation inselected patients admitted for acute respiratory failure dueto chronic obstructive pulmonary disease can obviate the needfor intubation and thus reduce complications and mortality andshorten the hospital stay.
Although noninvasive ventilation has been used in patients withchronic hypoventilatory syndromes, its use in patients withacute respiratory failure has not been firmly established,17,26since most of the studies have been retrospective and uncontrolled.Controlled studies are needed to assess both the efficacy andthe safety of this procedure. The results of previous studies,the rapidly reversible nature of most episodes of acute decompensation,and the presence of ventilatory failure rather than hypoxemiclung failure suggest that patients with acute exacerbationsof chronic obstructive pulmonary disease should benefit fromthis approach.
Recently, Bott and coworkers performed a prospective, randomizedstudy of the effects of nasal positive-pressure ventilationin patients with acute exacerbations of chronic obstructivepulmonary disease.16 Several physiologic measures and the degreeof breathlessness were significantly improved in the treatedgroup, as compared with the base-line values and with the datain the control group. This study suggests that benefits canbe expected from noninvasive ventilation. In a previous report,we compared the results in a treated group with those in a matchedhistorical control group.6 We found that the number of patientsrequiring intubation and the hospital stay were significantlyreduced with the use of pressure support through a face mask.These results are confirmed and extended in the present study.
Our enrollment criteria were designed to select patients whowere likely to need endotracheal intubation. Patients who requiredimmediate intubation were not included, although many patientsrequired intubation within the first hour. The criteria forintubation were not identical in the two groups, since noninvasiveventilation could be resumed in patients assigned to that treatmentwho had two minor criteria. Noninvasive ventilation was resumedin four patients but failed to prevent subsequent intubationin three of the four, indicating that this difference in thecriteria for intubation did not play an important part in theresults.
We found that mortality was significantly reduced with the useof noninvasive ventilation. This approach, as compared withstandard treatment, was associated with fewer complications,many of which are specifically linked with mechanical ventilationand are believed to have an effect on mortality.1,2,3 The mortalityrate appeared to be high in the control group14,27 but was similarto or lower than the rates reported by Bott and coworkers16and by other investigators.28,29,30,31 Our patients were probablyat a more severe stage of disease than those in the study byBott et al., as shown by the lower pH values in our patientson admission.27 Also, the complications and causes of deathcommonly described in patients with chronic obstructive pulmonarydisease were recorded in our patients.11 It is noteworthy thatthe mortality rate and the duration of the hospital stay weresimilar in the two subgroups of patients in whom endotrachealintubation was required. In addition, the difference in mortalitydisappeared after adjustment for intubation, suggesting thatthe benefits observed with noninvasive ventilation resultedfrom the lower number of patients requiring intubation.
The hospital stay was significantly shortened by noninvasiveventilation, a result in accordance with the findings of previousstudies.6,14 The absence of sedation, reduced number of complications,and shorter weaning time in the noninvasive-ventilation groupprobably all contributed to the shorter hospital stay. Thisresult suggests that noninvasive ventilation may be a cost-savingmeasure.
Finally, it should be stressed that our study was performedwith a carefully selected group of patients. In particular,patients with a clear cause of decompensation requiring a specifictherapeutic approach and those in need of immediate intubationwere not included in the study. Only 31 percent of all the patientswith chronic obstructive pulmonary disease admitted during thestudy period met the criteria for enrollment. With this limitationin mind, the study demonstrates that noninvasive ventilationcan reduce the need for endotracheal intubation in patientswith acute exacerbations of chronic obstructive pulmonary disease,thereby reducing associated complications, mortality, and lengthof hospitalization.
We are indebted to Christian Brun-Buisson for helpful commentson the manuscript, to Françoise Zerah for statisticaladvice, to Carolyn Newey for editorial assistance, and to FlorencePicot for assistance in the preparation of the manuscript.
Source Information
From the Medical Intensive Care Unit and INSERM, Unité 296, Henri Mondor Hospital, Créteil, France (L.B., A.R., F. Lemaire, D.I., A.H.); the Intensive Care Unit, International Hospital of the University of Paris, Paris (M.W.); the Respiratory Intensive Care Unit, Antoine Béclère Hospital, Clamart, France (F. Lofaso, G.S.); the Medical Intensive Care Unit, Sant Pau Hospital, Barcelona, Spain (J.M., S.B.); and the Intensive Care Unit, La Sapienza University Hospital, Rome (G.C., A.G.).
Address reprint requests to Dr. Brochard at Réanimation Médicale, Hôpital Henri Mondor, 94010 Créteil CEDEX, France.
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A correction has been published: N Engl J Med 1996;334(11):743.
