PROJECT HIGHLIGHTS

Governance Organization

SHS – Sunnybrook Medical Services Alternative Funding Plan Association

Project Title

SHS-21-006 – Prone positioning for patients on medical wards with COVID-19: a multicentre, international, pragmatic randomized trial [COVID-PRONE]

Project Highlights

We aimed to assess the effects of prone positioning in reducing the risk of respiratory failure or death in non-critically ill patients hospitalized with COVID-19 infection.

We completed a pragmatic randomized clinical trial of prone positioning of patients hospitalized with COVID-19 across 15 hospitals in Canada and the United States from May 2020 until May 2021. Patients were eligible if they had a laboratory-confirmed diagnosis or were highly suspected to have COVID-19. All patients required supplemental oxygen (up to 50% fraction of inspired oxygen [FiO2]), and were able to independently prone with verbal instruction. The primary outcome of interest was a composite of death, worsening respiratory failure (>/=60% fraction of inspired oxygen), or need for mechanical ventilation.

In total, 248 patients were included. Approximately 10% of trial participants were recruited from Sunnybrook Health Sciences Centre. The trial was stopped early due to futility for the primary outcome. The median age of patients was 56 years (interquartile range [IQR] 45,65), 36% were female, and 90% of patients were receiving oxygen via nasal prongs at the time of randomization. The median duration of prone positioning in the first 72 hours was 6 hours (IQR 1.5,12.8) for the prone arm as compared to 0 hours (0,2) in the control arm. The primary outcome occurred at a similar rate between the prone group (18 [14.3%] events) and the standard care group 4 (17 [13.9%] events), odds ratio 0.92 (95% CI 0.44 to 1.92). The change in the oxygen saturation to fraction of inspired oxygen ratio (S/F ratio) after 72 hours was similar for patients randomized to prone positioning compared to standard of care.

A multifaceted intervention focused on increasing prone positioning in hypoxemic patients hospitalized to medical wards with COVID-19 did not improve important clinical outcomes. Adherence to prone positioning was low, despite multiple efforts. Subsequent trials focused on prone positioning should incorporate strategies to improve adherence to prone positioning.

Theme

Prevention and Treatment

Primary Project Lead for Contact

Lee Fidler

Email

lee.fidler@sunnybrook.ca

Secondary Project Lead for Contact

Jon Zipursky

Email

jonathan.zipursky@sunnybrook.ca

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