Awake prone positioning of hypoxaemic patients with COVID-19: protocol for a randomised controlled open-label superiority meta-trial
Jie Li,
Yonatan Perez,
Jean-Pierre Frat,
Stephan Ehrmann,
Elsa Tavernier,
Bairbre McNicholas,
Ivan Pavlov,
Oriol Roca,
John Laffey,
Sara Mirza,
David Cosgrave,
David Vines
Affiliations
Jie Li
Department of Cardiopulmonary Sciences, Division of Respiratory Care, Rush University, Chicago, Illinois, USA
Yonatan Perez
Médecin Intensive Réanimation, CIC 1415, CRICS-TriggerSEP, Centre d`étude des pathologies respiratoires, INSERM U1100, Université de Tours, CHU Tours, Tours, Centre, France
Jean-Pierre Frat
Médecine Intensive Réanimation, Centre Hospitalier Universitaire de Poitiers, Poitiers, France
Stephan Ehrmann
Médecin Intensive Réanimation, CIC 1415, CRICS-TriggerSEP, Centre d`étude des pathologies respiratoires, INSERM U1100, Université de Tours, Centre Hospitalier Régional Universitaire de Tours, Tours, Centre, France
Elsa Tavernier
Biostatistics Department, Clinical Investigation Center-1415 INSERM, CHU Tours, Tours, France
Bairbre McNicholas
Department of Anaesthesia and Intensive Care Medicine, School of Medicine, National University of Ireland Galway, Galway, Ireland
Ivan Pavlov
Department of Emergency Medicine, Hopital de Verdun, Montreal, Quebec, Canada
Oriol Roca
Critical Care Department, Vall d`Hebron University Hospital, Vall d`Hebron Research Institute, Barcelona, Catalunya, Spain
John Laffey
Department of Anaesthesia and Intensive Care Medicine, School of Medicine, National University of Ireland Galway, Galway, Ireland
Sara Mirza
Department of Cardiopulmonary Sciences, Division of Respiratory Care, Rush University, Chicago, Illinois, USA
David Cosgrave
Department of Anaesthesia and Intensive Care Medicine, School of Medicine, National University of Ireland Galway, Galway, Ireland
David Vines
Department of Cardiopulmonary Sciences, Division of Respiratory Care, Rush University, Chicago, Illinois, USA
Introduction Prone positioning (PP) is an effective first-line intervention to treat patients with moderate to severe acute respiratory distress syndrome (ARDS) receiving invasive mechanical ventilation, as it improves gas exchanges and reduces mortality. The use of PP in awake spontaneous breathing patients with ARDS secondary to COVID-19 was reported to improve oxygenation in few retrospective trials with small sample size. High-level evidence of awake PP for hypoxaemic patients with COVID-19 patients is still lacking.Methods and analysis The protocol of this meta-trial is a prospective collaborative individual participant data meta-analysis of randomised controlled open label superiority trials. This design is particularly adapted to a rapid scientific response in the pandemic setting. It will take place in multiple sites, among others in USA, Canada, Ireland, France and Spain. Patients will be followed up for 28 days. Patients will be randomised to receive whether awake PP and nasal high flow therapy or standard medical treatment and nasal high flow therapy. Primary outcome is defined as the occurrence rate of tracheal intubation or death up to day 28. An interim analysis plan has been set up on aggregated data from the participating research groups.Ethics and dissemination Ethics approvals were obtained in all participating countries. Results of the meta-trial will be submitted for publication in a peer-reviewed journal. Each randomised controlled trial was registered individually, as follows: NCT04325906, NCT04347941, NCT04358939, NCT04395144 and NCT04391140.
