Prone positioning for 16 h/d reduced mortality more than supine positioning in early severe ARDS.

FRANCE; SPAIN

Question In adults with severe acute respiratory distress syndrome (ARDS), what is the efficacy of early prone positioning compared with supine positioning? Methods Design Randomized controlled trial (Proning Severe ARDS Patients [PROSEVA] study). ClinicalTrials.gov NCT00527813. Allocation Concealed.* Blinding Blinded* {patients, outcome assessors, data analysts, and safety committee}†. Follow-up period 90 days. Setting 26 intensive care units (ICUs) in France and 1 in Spain. Patients 474 adults (mean age 59 y, 68% men, mean Sepsis-related Organ Failure Assessment [SOFA] score 10.0) who had severe ARDS (confirmed as severe after 12 to 24 h of mechanical ventilation in the ICU) and were treated with mechanical ventilation for < 36 hours before randomization. Exclusion criteria included contraindication for prone positioning; use of inhaled nitric oxide, almitrine bismesylate, or extracorporeal membrane oxygenation before inclusion; lung transplantation; burns on > 20% of body surface; chronic respiratory failure requiring oxygen therapy or noninvasive ventilation; or prone positioning before inclusion. Eligibility was confirmed after a 12- to 24-hour stabilization period. Intervention Placement in prone position for ≥ 16 consecutive h/d for ≥ 28 days (n = 240) or supine, semirecumbent position (n = 234) during mechanical ventilation. Prone positioning began within 1 hour after randomization and was stopped if there was improvement in oxygenation when in the supine position for ≥ 4 hours, > 20% decrease in PaO2-FIO2 ratio during 2 consecutive prone sessions relative to the ratio in the supine position, or a complication during a prone session. Patients in the prone group could be returned to the prone position from the supine position if criteria for oxygen saturation level and/or PaO2 were met. Outcomes Mortality at 28 days. Secondary outcomes included mortality, successful extubation, and complications at 90 days. Patient follow-up 98% (intention-to-treat analysis). Main results Early prone positioning reduced mortality at 28 and 90 days and increased successful extubation compared with supine positioning (Table). Fewer cardiac arrests occurred in the prone group than in the supine group (6.8% vs 14%, P < 0.05); groups did not differ for other adverse events. Conclusion In adults with severe acute respiratory distress syndrome, early prone positioning for 16 h/d reduced mortality compared with supine positioning. [ABSTRACT FROM AUTHOR]

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