American journal of respiratory and critical care medicine
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Am. J. Respir. Crit. Care Med. · Dec 2019
Randomized Controlled Trial Multicenter StudyMaximal Recruitment Open Lung Ventilation in Acute Respiratory Distress Syndrome (PHARLAP): A Phase II, Multicenter, Randomized, Controlled Trial.
Rationale: Open lung ventilation strategies have been recommended in patients with acute respiratory distress syndrome (ARDS). Objectives: To determine whether a maximal lung recruitment strategy reduces ventilator-free days in patients with ARDS. Methods: A phase II, multicenter randomized controlled trial in adults with moderate to severe ARDS. ⋯ However, the intervention group showed reduced use of new hypoxemic adjuvant therapies (i.e., inhaled nitric oxide, extracorporeal membrane oxygenation, prone; median change from baseline 0 [IQR, 0-1] vs. 1 [IQR, 0-1]; P = 0.004) and increased rates of new cardiac arrhythmia (n = 17 [29%] vs. n = 7 [13%]; P = 0.03). Conclusions: Compared with control ventilation, maximal lung recruitment did not reduce the duration of ventilation-free days or mortality and was associated with increased cardiovascular adverse events but lower use of hypoxemic adjuvant therapies. Clinical trial registered with www.clinicaltrials.gov (NCT01667146).