Prone Positioning During Extracorporeal Membrane Oxygenation in Patients With Severe ARDS: The PRONECMO Randomized Clinical Trial.

Autor: Schmidt M; Sorbonne Université, INSERM, UMRS_1166-ICAN, Institute of Cardiometabolism and Nutrition, Paris, France.; Assistance Publique-Hôpitaux de Paris, Service de Médecine Intensive-Réanimation, Institut de Cardiologie, Hôpital Pitié-Salpêtrière, Paris, France.; GRC 30 RESPIRE, Sorbonne Université, Paris, France., Hajage D; Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Département de Santé Publique, Centre de Pharmacoépidémiologie (Cephepi), CIC-1421, Paris, France., Lebreton G; Sorbonne Université, INSERM, UMRS_1166-ICAN, Institute of Cardiometabolism and Nutrition, Paris, France.; Assistance Publique-Hôpitaux de Paris, Thoracic and Cardiovascular Department, Hôpital Pitié-Salpêtrière, Paris France., Dres M; GRC 30 RESPIRE, Sorbonne Université, Paris, France.; Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Universitaire APHP-Sorbonne Université, Site Pitié-Salpêtrière, Service de Médecine Intensive et Réanimation (Département R3S), et Sorbonne Université, INSERM, UMRS-1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France., Guervilly C; Médecine Intensive Réanimation, Hôpital Nord, AP-HM, Centre d'Etudes et de Recherches sur les Services de Santé et Qualité de Vie EA 3279, Marseille, France., Richard JC; Médecine Intensive Réanimation, Hospices Civils de Lyon, Hôpital de la Croix Rousse, Lyon, France., Sonneville R; Université Paris Cité, INSERM U1137, F-75018 Paris, APHP Nord, Service de Médecine Intensive Réanimation, Hôpital Bichat-Claude Bernard, Paris, France., Winiszewski H; Service de Médecine Intensive Réanimation, CHU Besançon, Besançon, France., Muller G; Service de Médecine Intensive-Réanimation, Centre Hospitalier Régional d'Orléans, Orléans, France., Beduneau G; Université Rouen Normandie, Normandie Université, GRHVN UR 3830, Medical Intensive Care Unit, Rouen University Hospital, Rouen, France., Mercier E; Service de Médecine Intensive Réanimation, CHU de Tours, CRICS-TRIGGERSEP Network, Tours, France., Roze H; Service d'Anesthésie Réanimation Thoraco-Abdominale, CMC Magellan, Hôpital, Haut Leveque, CHU de Bordeaux, INSERM 1045: Centre de Recherche Cardio-Thoracique, Université de Bordeaux, Pessac, France., Lesouhaitier M; CHU Rennes, Service de Maladies Infectieuses et Réanimation Médicale, Rennes, France., Terzi N; Service de Médecine Intensive Réanimation, Université de Grenoble-Alpes, Inserm U1042, Grenoble, France., Thille AW; CHU de Poitiers, Médecine Intensive Réanimation, Poitiers, France., Laurent I; Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Département de Santé Publique, Centre de Pharmacoépidémiologie (Cephepi), CIC-1421, Paris, France., Kimmoun A; Université de Lorraine, CHRU de Nancy, Institut Lorrain du Cœur et des Vaisseaux, Service de Médecine Intensive-Réanimation, U1116, FCRIN-INICRCT, Nancy, France., Combes A; Sorbonne Université, INSERM, UMRS_1166-ICAN, Institute of Cardiometabolism and Nutrition, Paris, France.; Assistance Publique-Hôpitaux de Paris, Service de Médecine Intensive-Réanimation, Institut de Cardiologie, Hôpital Pitié-Salpêtrière, Paris, France.; GRC 30 RESPIRE, Sorbonne Université, Paris, France.
Jazyk: angličtina
Zdroj: JAMA [JAMA] 2023 Dec 26; Vol. 330 (24), pp. 2343-2353.
DOI: 10.1001/jama.2023.24491
Abstrakt: Importance: Prone positioning may improve outcomes in patients with severe acute respiratory distress syndrome (ARDS), but it is unknown whether prone positioning improves clinical outcomes among patients with ARDS who are undergoing venovenous extracorporeal membrane oxygenation (VV-ECMO) compared with supine positioning.
Objective: To test whether prone positioning vs supine positioning decreases the time to successful ECMO weaning in patients with severe ARDS supported by VV-ECMO.
Design, Setting, and Participants: Randomized clinical trial of patients with severe ARDS undergoing VV-ECMO for less than 48 hours at 14 intensive care units (ICUs) in France between March 3, 2021, and December 7, 2021.
Interventions: Patients were randomized 1:1 to prone positioning (at least 4 sessions of 16 hours) (n = 86) or to supine positioning (n = 84).
Main Outcomes and Measures: The primary outcome was time to successful ECMO weaning within 60 days following randomization. Secondary outcomes included ECMO and mechanical ventilation-free days, ICU and hospital length of stay, skin pressure injury, serious adverse events, and all-cause mortality at 90-day follow-up.
Results: Among 170 randomized patients (median age, 51 [IQR, 43-59] years; n = 60 women [35%]), median respiratory system compliance was 15.0 (IQR, 10.7-20.6) mL/cm H2O; 159 patients (94%) had COVID-19-related ARDS; and 164 (96%) were in prone position before ECMO initiation. Within 60 days of enrollment, 38 of 86 patients (44%) had successful ECMO weaning in the prone ECMO group compared with 37 of 84 (44%) in the supine ECMO group (risk difference, 0.1% [95% CI, -14.9% to 15.2%]; subdistribution hazard ratio, 1.11 [95% CI, 0.71-1.75]; P = .64). Within 90 days, no significant difference was observed in ECMO duration (28 vs 32 days; difference, -4.9 [95% CI, -11.2 to 1.5] days; P = .13), ICU length of stay, or 90-day mortality (51% vs 48%; risk difference, 2.4% [95% CI, -13.9% to 18.6%]; P = .62). No serious adverse events were reported during the prone position procedure.
Conclusions and Relevance: Among patients with severe ARDS supported by VV-ECMO, prone positioning compared with supine positioning did not significantly reduce time to successful weaning of ECMO.
Trial Registration: ClinicalTrials.gov Identifier: NCT04607551.
Databáze: MEDLINE