Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial,The Lancet Respiratory Medicine

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Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial
The Lancet Respiratory Medicine ( IF 38.7 ) Pub Date : 2021-08-20 , DOI: 10.1016/s2213-2600(21)00356-8
Stephan Ehrmann ₁ , Jie Li ₂ , Miguel Ibarra-Estrada ₃ , Yonatan Perez ₄ , Ivan Pavlov ₅ , Bairbre McNicholas ₆ , Oriol Roca ₇ , Sara Mirza ₂ , David Vines ₂ , Roxana Garcia-Salcido ₃ , Guadalupe Aguirre-Avalos ₃ , Matthew W Trump ₈ , Mai-Anh Nay ₉ , Jean Dellamonica ₁₀ , Saad Nseir ₁₁ , Idrees Mogri ₁₂ , David Cosgrave ₆ , Dev Jayaraman ₁₃ , Joan R Masclans ₁₄ , John G Laffey ₆ , Elsa Tavernier ₁₅ ,

Affiliation

CHRU Tours, Médecine Intensive Réanimation, CIC INSERM 1415, CRICS-TriggerSep F-CRIN research network, Tours, France; INSERM, Centre d'étude des pathologies respiratoires, U1100, Université de Tours, Tours, France.
Department of Cardiopulmonary Sciences, Division of Respiratory Care, Rush University, Chicago, IL, USA.
Unidad de Terapia Intensiva, Hospital Civil Fray Antonio Alcalde Guadalajara, Jalisco, México.
CHRU Tours, Médecine Intensive Réanimation, CIC INSERM 1415, CRICS-TriggerSep F-CRIN research network, Tours, France.
Department of Emergency Medicine, Hôpital de Verdun, Montréal, QC, Canada.
Department of Anesthesia and Intensive Care Medicine, Galway University Hospitals, HRB Galway Clinical Research Facility, Galway, Ireland; School of Medicine, National University of Ireland, Galway, Ireland.
Servei de Medicina Intensiva, Hospital Universitari Vall d'Hebron, Barcelona, Spain; Ciber Enfermedades Respiratorias (CIberes), Instituto de Salud Carlos III, Madrid, Spain.
The Iowa Clinic P.C. and Unity Point Health-Des Moines, Des Moines, IA, USA.
Medical intensive care unit, Centre Hospitalier Régional d'Orléans, Orléans, France.
UR2CA Unité de Recherche Clinique Université Côte d'Azur, Nice, France; Médecine Intensive Réanimation-CHU de Nice, Nice, France.
Pôle de Médecine Intensive-Réanimation, CHU Lille, Lille, France; Inserm U1285, University of Lille, CNRS, UMR 8576, Unité de Glycobiologie Structurale et Fonctionnelle, Lille, France.
Pulmonary and Critical Care Medicine Division, Texas A&M School of Medicine, Baylor University Medical Center, Dallas, TX, USA.
Division of Critical Care, McGill University Healthcare Center Montréal, QC, Canada; Jewish General Hospital, Montréal, QC, Canada.
Critical Care Department, Hospital del Mar, IMIM (Hospital del Mar Research Institute) Barcelona, Spain; Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain.
Clinical Investigation Center, INSERM 1415, CHRU Tours, Tours, France; Methods in Patients-Centered Outcomes and Health Research, INSERM UMR 1246, Nantes, France.

Background

Awake prone positioning has been reported to improve oxygenation for patients with COVID-19 in retrospective and observational studies, but whether it improves patient-centred outcomes is unknown. We aimed to evaluate the efficacy of awake prone positioning to prevent intubation or death in patients with severe COVID-19 in a large-scale randomised trial.

Methods

In this prospective, a priori set up and defined, collaborative meta-trial of six randomised controlled open-label superiority trials, adults who required respiratory support with high-flow nasal cannula for acute hypoxaemic respiratory failure due to COVID-19 were randomly assigned to awake prone positioning or standard care. Hospitals from six countries were involved: Canada, France, Ireland, Mexico, USA, Spain. Patients or their care providers were not masked to allocated treatment. The primary composite outcome was treatment failure, defined as the proportion of patients intubated or dying within 28 days of enrolment. The six trials are registered with ClinicalTrials.gov, NCT04325906, NCT04347941, NCT04358939, NCT04395144, NCT04391140, and NCT04477655.

Findings

Between April 2, 2020 and Jan 26, 2021, 1126 patients were enrolled and randomly assigned to awake prone positioning (n=567) or standard care (n=559). 1121 patients (excluding five who withdrew from the study) were included in the intention-to-treat analysis. Treatment failure occurred in 223 (40%) of 564 patients assigned to awake prone positioning and in 257 (46%) of 557 patients assigned to standard care (relative risk 0·86 [95% CI 0·75−0·98]). The hazard ratio (HR) for intubation was 0·75 (0·62−0·91), and the HR for mortality was 0·87 (0·68−1·11) with awake prone positioning compared with standard care within 28 days of enrolment. The incidence of prespecified adverse events was low and similar in both groups.

Interpretation

Awake prone positioning of patients with hypoxaemic respiratory failure due to COVID-19 reduces the incidence of treatment failure and the need for intubation without any signal of harm. These results support routine awake prone positioning of patients with COVID-19 who require support with high-flow nasal cannula.

Funding

Open AI inc, Rice Foundation, Projet Hospitalier de Recherche Clinique Interrégional, Appel d'Offre 2020, Groupement Interrégional de Recherche Clinique et d'Innovation Grand Ouest, Association pour la Promotion à Tours de la Réanimation Médicale, Fond de dotation du CHRU de Tours, Fisher & Paykel Healthcare Ltd.

中文翻译：

清醒俯卧位治疗 COVID-19 急性低氧血症性呼吸衰竭：一项随机、对照、多国、开放标签荟萃试验

背景

据报道，在回顾性和观察性研究中，清醒俯卧位可以改善 COVID-19 患者的氧合，但是否可以改善以患者为中心的结果尚不清楚。我们的目的是在一项大规模随机试验中评估清醒俯卧位对于预防重症 COVID-19 患者插管或死亡的功效。

方法

在这一前瞻性研究中，对六项随机对照开放标签优效性试验进行了先验设置和明确的协作荟萃试验，将因 COVID-19 导致的急性低氧性呼吸衰竭而需要高流量鼻插管呼吸支持的成年人随机分配到清醒俯卧位或标准护理。来自六个国家的医院参与其中：加拿大、法国、爱尔兰、墨西哥、美国、西班牙。患者或他们的护理人员不会隐瞒分配的治疗。主要复合结局是治疗失败，定义为入组后 28 天内插管或死亡的患者比例。这六项试验已在 ClinicalTrials.gov 注册，编号为 NCT04325906、NCT04347941、NCT04358939、NCT04395144、NCT04391140 和 NCT04477655。

发现

2020年4月2日至2021年1月26日期间，共招募了1126名患者，并随机分配至清醒俯卧位（n=567）或标准护理组（n=559）。意向治疗分析纳入了 1121 名患者（不包括 5 名退出研究的患者）。 564 名分配至清醒俯卧位的患者中有 223 名 (40%) 发生治疗失败，557 名分配至标准护理的患者中有 257 名 (46%) 发生治疗失败（相对风险 0·86 [95% CI 0·75−0·98]）。清醒俯卧位与标准护理相比，28 天内插管的风险比 (HR) 为 0·75 (0·62−0·91)，死亡率 HR 为 0·87 (0·68−1·11)报名的天数。两组中预设不良事件的发生率较低且相似。