Acute respiratory failure in randomized trials of noninvasive respiratory support: A systematic review of definitions, patient characteristics, and criteria for intubation

Purpose: To examine the definitions of acute respiratory failure, the characteristics of recruited patients, and the criteria for intubation used in randomized trials. Methods: We searched MEDLINE for randomized trials of noninvasive respiratory support modalities in patients with de novo respiratory failure. We included trials from 1995 to 2017 that enrolled 40 or more patients and used intubation as an outcome. Results: We examined the reports of 53 trials that enrolled 7225 patients. There was wide variation in the use of variables for defining acute respiratory failure. Dyspnea was rarely measured and the increase in breathing effort was poorly defined. The characteristics of patients enrolled in trials changed over time and differed by the cause of respiratory failure. Intubation was poorly characterized. The criteria for intubation had more variables than the criteria for respiratory failure. Conclusions: We identified deficiencies in the design and reporting of randomized trials, some of which can be remedied by investigators. We also found that patient characteristics differ by the type of respiratory failure. This knowledge can help clinician identify patients at the right moment to benefit from the tested interventions and investigators in developing criteria for enrollment in future trials.