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A Randomized Controlled Trial

Paolo Taccone, MD; Antonio Pesenti, MD; Roberto Latini, MD; Federico Polli, MD; Federica Vagginelli, MD; Cristina Mietto, MD; Luisa Caspani, MD; Ferdinando Raimondi, MD; Giovanni Bordone, MD; Gaetano Iapichino, MD; Jordi Mancebo, MD; Claude Guérin, MD; Louis Ayzac, MD; Lluis Blanch, MD; Roberto Fumagalli, MD; Gianni Tognoni, MD; Luciano Gattinoni, MD, FRCP; for the Prone-Supine II Study Group

JAMA. 2009;302(18):1977-1984.

Context  Post hoc analysis of a previous trial has suggested that prone positioning may improve survival in patients with severe hypoxemia and with acute respiratory distress syndrome (ARDS).

Objective  To assess possible outcome benefits of prone positioning in patients with moderate and severe hypoxemia who are affected by ARDS.

Design, Setting, and Patients  The Prone-Supine II Study, a multicenter, unblinded, randomized controlled trial conducted in 23 centers in Italy and 2 in Spain. Patients were 342 adults with ARDS receiving mechanical ventilation, enrolled from February 2004 through June 2008 and prospectively stratified into subgroups with moderate (n = 192) and severe (n = 150) hypoxemia.

Interventions  Patients were randomized to undergo supine (n = 174) or prone (20 hours per day; n = 168) positioning during ventilation.

Main Outcome Measures  The primary outcome was 28-day all-cause mortality. Secondary outcomes were 6-month mortality and mortality at intensive care unit discharge, organ dysfunctions, and the complication rate related to prone positioning.

Results  Prone and supine patients from the entire study population had similar 28-day (31.0% vs 32.8%; relative risk [RR], 0.97; 95% confidence interval [CI], 0.84-1.13; P = .72) and 6-month (47.0% vs 52.3%; RR, 0.90; 95% CI, 0.73-1.11; P = .33) mortality rates, despite significantly higher complication rates in the prone group. Outcomes were also similar for patients with moderate hypoxemia in the prone and supine groups at 28 days (25.5% vs 22.5%; RR, 1.04; 95% CI, 0.89-1.22; P = .62) and at 6 months (42.6% vs 43.9%; RR, 0.98; 95% CI, 0.76-1.25; P = .85). The 28-day mortality of patients with severe hypoxemia was 37.8% in the prone and 46.1% in the supine group (RR, 0.87; 95% CI, 0.66-1.14; P = .31), while their 6-month mortality was 52.7% and 63.2%, respectively (RR, 0.78; 95% CI, 0.53-1.14; P = .19).

Conclusion  Data from this study indicate that prone positioning does not provide significant survival benefit in patients with ARDS or in subgroups of patients with moderate and severe hypoxemia.

Trial Registration  clinicaltrials.gov Identifier: NCT00159939

Author Affiliations: Dipartimento di Anestesia e Rianimazione, Fondazione IRCCS–"Ospedale Maggiore Policlinico, Mangiagalli, Regina Elena" di Milano, Milan, Italy (Drs Taccone, Vagginelli, Caspani, and Gattinoni); Dipartimento di Medicina Perioperatoria e Terapie Intensive, Azienda Ospedaliera San Gerardo di Monza, Monza, Italy (Drs Pesenti and Fumagalli); Department of Cardiovascular Research, Istituto di Ricerche Farmacologiche Mario Negri, Milan (Dr Latini); Istituto di Anestesiologia e Rianimazione, Università degli Studi di Milano, Milan (Drs Polli, Mietto, Iapichino, and Gattinoni); U. O. di Anestesia e Rianimazione, Azienda Ospedaliera Polo Universitario San Paolo, Milan (Dr Iapichino); Dipartimento di Medicina Sperimentale, Università degli Studi Milano-Bicocca, Milan (Drs Pesenti and Fumagalli); U. O. di Anestesia e Rianimazione, Polo Universitario Luigi Sacco, Milan (Dr Raimondi); Dipartimento di Anestesia e Rianimazione Generale, Istituto Clinico Humanitas, Rozzano, Italy (Dr Bordone); Servei de Medicina Intensiva, Hospital de Sant Pau, Barcelona, Spain (Dr Mancebo); Service de Réanimation Médicale et Assistance Respiratoire, Hôpital de la Croix-Rousse, Lyon, France (Dr Guérin); Centre de Coordination de la Lutte contre les Infections Nosocomiales Sud-Est, Hospital Henry Gabrielle, St. Genis Laval, France (Dr Ayzac); Critical Care Center, CIBER Enfermedades Respiratorias, Corporació Sanitaria Parc Tauli, Universitat Autònoma de Barcelona, Sabadell, Spain (Dr Blanch); Consorzio Mario Negri Sud, S. Maria Imbaro, Italy (Dr Tognoni).

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