Abstract
RationaleOur pilot study suggested that noninvasive ventilation (NIV) reduced the need for intubation compared with conventional administration of oxygen on patients with “early” stage of mild acute respiratory distress syndrome (ARDS, PaO2/FIO2 between 200 and 300).ObjectivesTo evaluate whether early NIV can reduce the need for invasive ventilation in patients with pneumonia-induced early mild ARDS.MethodsProspective, multicenter, randomized controlled trial (RCT) of NIV compared with conventional administration of oxygen through a Venturi mask. Primary outcome included the numbers of patients who met the intubation criteria.ResultsTwo hundred subjects were randomized to NIV (n = 102) or control (n = 98) groups from 21 centers. Baseline characteristics were similar in the two groups. In the NIV group, PaO2/FIO2 became significantly higher than in the control group at 2 h after randomization and remained stable for the first 72 h. NIV did not decrease the proportion of patients requiring intubation than in the control group (11/102 vs. 9/98, 10.8% vs. 9.2%, p = 0.706). The ICU mortality was similar in the two groups (7/102 vs. 7/98, 4.9% vs. 3.1%, p = 0.721). Multivariate analysis showed minute ventilation greater than 11 L/min at 48 h was the independent risk factor for NIV failure (OR, 1.176 [95% CI, 1.005–1.379], p = 0.043).ConclusionsTreatment with NIV did not reduce the need for intubation among patients with pneumonia-induced early mild ARDS, despite the improved PaO2/FIO2 observed with NIV compared with standard oxygen therapy. High minute ventilation may predict NIV failure.Trial registrationNCT01581229. Registered 19 April 2012
Highlights
Acute respiratory distress syndrome (ARDS) mortality ranges from 35 to 46%
Treatment with noninvasive ventilation (NIV) did not reduce the need for intubation among patients with pneumonia-induced early mild ARDS, despite the improved PaO2/FIO2 observed with NIV compared with standard oxygen therapy
Patients with contraindications of NIV, severe organ failure, unable to cooperate with NIV, or ARDS caused by extra-pulmonary reasons were excluded
Summary
Acute respiratory distress syndrome (ARDS) mortality ranges from 35 to 46%. Mortality is related to the severity of ARDS and remains high despite improvement in recent years [1]. Noninvasive positive-pressure ventilation (hereafter, noninvasive ventilation, NIV) reduces the need for endotracheal intubation and mortality among patients with acute respiratory failure [2, 3], but its use in ARDS is uncertain [4]. Previous studies often included a heterogeneous population of patients with ARDS caused by pulmonary infection, sepsis, acute pancreatitis, or multiple trauma; this selection of patients could lead to an overestimation of the beneficial effects of NIV as compared with standard oxygen therapy. In observational ARDS studies, the rate of treatment failure with NIV was as high as 50% [5,6,7] and associated with high mortality in pulmonary infection-induced ARDS [8]. NIV use in ARDS remains highly controversial [9,10,11], especially in pneumonia-induced ARDS
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