Prone positioning of patients with moderate hypoxaemia due to covid-19: multicentre pragmatic randomised trial (COVID-PRONE).

To assess the effectiveness of prone positioning to reduce the risk of death or respiratory failure in non-critically ill patients admitted to hospital with covid-19. Multicentre pragmatic randomised clinical trial. 15 hospitals in Canada and the United States from May 2020 until May 2021. Eligible patients had a laboratory confirmed or a clinically highly suspected diagnosis of covid-19, needed supplemental oxygen (up to 50% fraction of inspired oxygen), and were able to independently lie prone with verbal instruction. Of the 570 patients who were assessed for eligibility, 257 were randomised and 248 were included in the analysis. Patients were randomised 1:1 to prone positioning (that is, instructing a patient to lie on their stomach while they are in bed) or standard of care (that is, no instruction to adopt prone position). The primary outcome was a composite of in-hospital death, mechanical ventilation, or worsening respiratory failure defined as needing at least 60% fraction of inspired oxygen for at least 24 hours. Secondary outcomes included the change in the ratio of oxygen saturation to fraction of inspired oxygen. The trial was stopped early on the basis of futility for the pre-specified primary outcome. The median time from hospital admission until randomisation was 1 day, the median age of patients was 56 (interquartile range 45-65) years, 89 (36%) patients were female, and 222 (90%) were receiving oxygen via nasal prongs at the time of randomisation. The median time spent prone in the first 72 hours was 6 (1.5-12.8) hours in total for the prone arm compared with 0 (0-2) hours in the control arm. The risk of the primary outcome was similar between the prone group (18 (14%) events) and the standard care group (17 (14%) events) (odds ratio 0.92, 95% confidence interval 0.44 to 1.92). The change in the ratio of oxygen saturation to fraction of inspired oxygen after 72 hours was similar for patients randomised to prone positioning and standard of care. Among non-critically ill patients with hypoxaemia who were admitted to hospital with covid-19, a multifaceted intervention to increase prone positioning did not improve outcomes. However, wide confidence intervals preclude definitively ruling out benefit or harm. Adherence to prone positioning was poor, despite multiple efforts to increase it. Subsequent trials of prone positioning should aim to develop strategies to improve adherence to awake prone positioning. ClinicalTrials.gov NCT04383613.

Informations de copyright

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: the study was funded by St Michael’s Hospital Innovation Fund, the Sinai Health Research Fund, and Sunnybrook Health Sciences Centre Alternate Funding Plan Innovation Fund; JZ has received payments for medicolegal opinions regarding the safety and effectiveness of drugs outside the submitted work; AV is provincial clinical lead for quality improvement in general internal medicine at Ontario Health and an AMS healthcare fellow in compassion and artificial intelligence and has received funding for covid related research from CIHR, Canadian Frailty Network, St Michael's Hospital, Sinai Health System, and St Michael's Hospital Foundation; MF is a consultant for a start-up company (ProofDx) that has developed a point-of-care diagnostic test for covid-19 using CRISPR; FR has received an award from the Mak Pak Chiu and Mak-Soo Lai Hing chair in general internal medicine, University of Toronto, outside the submitted work and is an employee of Ontario Health; no other relationships or activities that could appear to have influenced the submitted work.