PROSEVA: Prone Positioning in Severe Acute Respiratory Distress Syndrome
Guerin et al for the PROSEVA Study Group. NEJM 2013;368:2159-68.
- Does the early application of prone positioning improve mortality in severe ARDS?
- RCT, computer generated, stratified by ICU
- Blinding of outcome assessors
- 27 centres in France and Spain, all with >5 years experience of proning
- 01.01.2008. – 25.07.2011.
- Adult patients with severe ARDS who were intubated/ventilated for <36 hours at inclusion
- PaO2:FiO2 <150mmHg (20Kpa) with FiO2 ≥0.6, PEEP ≥5, TV~6ml/kg, confirmed after 12-24 hours of ventilation
- Excluded if contraindication to proning
- 474 patients randomised from 3449 patients with ARDS
- Prone for at least 16 consecutive hours, for 28 days, or until improvement to set standard
- Supine (semi-recumbent position)
- Primary outcome: all cause mortality at 28-days
- 16% in prone vs. 32.8% in supine (P<0.001)
- adjusted odds ratio 0.42 (0.26-0.66)
- No increase in adverse events in prone group
- Patients with severe ARDS have improved mortality with early and long proning sessions
- Standardised ventilation and weaning strategy with use of PEEP-FiO2 table
- Appropriate power calculation
- Intention to treat analysis
- 2015 patients not screened for inclusion in trial. ?selection bias
- Differences in baseline characteristics. Comparing prone to supine group, at inclusion in the study:
- SOFA score 10.4 vs. 9.6
- Use of Vasopressors 83% vs. 72.6%
- Use of neuromuscular blockers 82.3% vs. 91%
- Centres all had >5 years with proning therefore results may not be generalisable to centres with limited experience
The Bottom Line
- Proning in severe ARDS reduces mortality without an increase in adverse outcomes. Further studies are required to confirm these findings but in the mean time these results are difficult to ignore.