Prone Positioning in Patients With Moderate and Severe Acute Respiratory Distress Syndrome A Randomized Controlled Trial
Por:
Taccone, P, Pesenti, A, Latini, R, Polli, F, Vagginelli, F, Mietto, C, Caspani, L, Raimondi, F, Bordone, G, Iapichino, G, Mancebo, J, Guerin, C, Ayzac, L, Blanch, L, Fumagalli, R, Tognoni, G, Gattinoni, L
Publicada:
11 nov 2009
Resumen:
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 JAMA. 2009;302(18):1977-1984
Filiaciones:
Taccone, P:
Fdn IRCCS Osped Maggiore Policlin Mangiagalli Reg, Dipartimento Anestesia & Rianimaz, I-20122 Milan, Italy
Pesenti, A:
Azienda Osped San Gerardo Monza, Dipartimento Med Perioperatoria & Terapie Intens, Monza, Italy
Univ Milano Bicocca, Dipartimento Med Sperimentale, Milan, Italy
Latini, R:
Ist Ric Farmacol Mario Negri, Dept Cardiovasc Res, Milan, Italy
Polli, F:
Univ Milan, Ist Anestesiol & Rianimaz, Milan, Italy
Vagginelli, F:
Fdn IRCCS Osped Maggiore Policlin Mangiagalli Reg, Dipartimento Anestesia & Rianimaz, I-20122 Milan, Italy
Mietto, C:
Univ Milan, Ist Anestesiol & Rianimaz, Milan, Italy
Caspani, L:
Fdn IRCCS Osped Maggiore Policlin Mangiagalli Reg, Dipartimento Anestesia & Rianimaz, I-20122 Milan, Italy
Raimondi, F:
Polo Univ Luigi Sacco, UO Anestesia & Rianimaz, Milan, Italy
Bordone, G:
Ist Clin Humanitas, Dipartimento Anestesia & Rianimaz Gen, Rozzano, Italy
Iapichino, G:
Univ Milan, Ist Anestesiol & Rianimaz, Milan, Italy
Azienda Osped Polo Univ San Paolo, UO Anestesia & Rianimaz, Milan, Italy
Mancebo, J:
Hosp Sant Pau, Serv Med Intens, Barcelona, Spain
Guerin, C:
Hop Croix Rousse, Serv Reanimat Med & Assistance Resp, F-69317 Lyon, France
Ayzac, L:
Hosp Henry Gabrielle, Ctr Coordinat Lutte Infect Nosocomi Sud Est, St Genis Laval, France
Blanch, L:
Univ Autonoma Barcelona, Crit Care Ctr, CIBER Enfermedades Resp, Corp Sanitaria Parc Tauli, Sabadell, Spain
Fumagalli, R:
Azienda Osped San Gerardo Monza, Dipartimento Med Perioperatoria & Terapie Intens, Monza, Italy
Univ Milano Bicocca, Dipartimento Med Sperimentale, Milan, Italy
Tognoni, G:
Ist Ric Farmacol Mario Negri, Consorzio Mario Negri Sud, I-66030 Santa Maria Imbaro, Italy
Gattinoni, L:
Fdn IRCCS Osped Maggiore Policlin Mangiagalli Reg, Dipartimento Anestesia & Rianimaz, I-20122 Milan, Italy
Univ Milan, Ist Anestesiol & Rianimaz, Milan, Italy
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