Waleed Alhazzani1,2,3,4, Ken Kuljit S Parhar5,6,7, Jason Weatherald6,7,8,9, Zainab Al Duhailib10,11, Mohammed Alshahrani12, Abdulrahman Al-Fares13, Sarah Buabbas14, Sujith V Cherian15, Laveena Munshi16,17, Eddy Fan16,17, Fahad Al-Hameed18,19, Jamal Chalabi20,21, Amera A Rahmatullah10, Erick Duan1,2,4,22, Jennifer L Y Tsang1,22, Kimberley Lewis1,4, François Lauzier23,24, John Centofanti25, Bram Rochwerg1,2, Sarah Culgin4, Katlynne Nelson4, Sheryl Ann Abdukahil26,27,28, Kirsten M Fiest5,29,30, Henry T Stelfox5,29, Haytham Tlayjeh26,27,28, Maureen O Meade1,2, Dan Perri1,4, Kevin Solverson5,8, Daniel J Niven5, Rachel Lim8, Morten Hylander Møller31, Emilie Belley-Cote1,32, Lehana Thabane2,4, Hani Tamim11,33, Deborah J Cook1,2,4, Yaseen M Arabi26,27,28. 1. Department of Medicine, McMaster University, Hamilton, Ontario, Canada. 2. Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada. 3. Department of Critical Care, College of Medicine, King Saud University, Riyadh, Saudi Arabia. 4. Research Institute of St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada. 5. Department of Critical Care Medicine, Alberta Health Services and University of Calgary, Calgary, Canada. 6. Libin Cardiovascular Institute, University of Calgary, Calgary, Alberta, Canada. 7. O'Brien Institute for Public Health, Calgary, Alberta, Canada. 8. Division of Respirology, Department of Medicine, University of Calgary, Calgary, Alberta, Canada. 9. Division of Pulmonary Medicine, Department of Medicine, University of Alberta, Edmonton, Canada. 10. Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia. 11. College of Medicine, Alfaisal University, Riyadh, Saudi Arabia. 12. Department of Emergency and Critical Care, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia. 13. Department of Anesthesia, Critical Care Medicine, and Pain Medicine, Al Amiri Hospital, Kuwait City, Kuwait. 14. Department of Anesthesia, Critical Care Medicine, and Pain Medicine, Jaber Al-Ahmad Al-Sabah Hospital, Kuwait City, Kuwait. 15. Department of Internal Medicine, Divisions of Critical Care, Pulmonary, and Sleep Medicine, University of Texas Health-McGovern Medical School, Houston. 16. Interdepartmental Division of Critical Care, University of Toronto, Toronto, Ontario, Canada. 17. University Health Network, Toronto, Ontario, Canada. 18. Department of Intensive Care, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia. 19. King Abdullah International Medical Research Center, King Abdulaziz Medical City, Jeddah, Saudi Arabia. 20. Intensive Care Department, Ministry of National Guard Health Affairs, Al Ahsa, Saudi Arabia. 21. King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Al Ahsa, Saudi Arabia. 22. Division of Critical Care, Niagara Health, St Catharines, Ontario, Canada. 23. Department of Medicine, Université Laval, Québec City, Québec, Canada. 24. Department of Anesthesiology and Critical Care, Division of Critical Care, Université Laval, Québec City, Québec, Canada. 25. Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada. 26. College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia. 27. King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. 28. Intensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia. 29. Department of Community Health Sciences and O'Brien Institute for Public Health, University of Calgary, Calgary, Alberta, Canada. 30. Department of Psychiatry and Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada. 31. Department of Intensive Care, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark. 32. Population Health Research Institute, Hamilton, Ontario, Canada. 33. Department of Emergency Medicine, American University of Beirut, Beirut, Lebanon.
Abstract
Importance: The efficacy and safety of prone positioning is unclear in nonintubated patients with acute hypoxemia and COVID-19. Objective: To evaluate the efficacy and adverse events of prone positioning in nonintubated adult patients with acute hypoxemia and COVID-19. Design, Setting, and Participants: Pragmatic, unblinded randomized clinical trial conducted at 21 hospitals in Canada, Kuwait, Saudi Arabia, and the US. Eligible adult patients with COVID-19 were not intubated and required oxygen (≥40%) or noninvasive ventilation. A total of 400 patients were enrolled between May 19, 2020, and May 18, 2021, and final follow-up was completed in July 2021. Intervention: Patients were randomized to awake prone positioning (n = 205) or usual care without prone positioning (control; n = 195). Main Outcomes and Measures: The primary outcome was endotracheal intubation within 30 days of randomization. The secondary outcomes included mortality at 60 days, days free from invasive mechanical ventilation or noninvasive ventilation at 30 days, days free from the intensive care unit or hospital at 60 days, adverse events, and serious adverse events. Results: Among the 400 patients who were randomized (mean age, 57.6 years [SD, 12.83 years]; 117 [29.3%] were women), all (100%) completed the trial. In the first 4 days after randomization, the median duration of prone positioning was 4.8 h/d (IQR, 1.8 to 8.0 h/d) in the awake prone positioning group vs 0 h/d (IQR, 0 to 0 h/d) in the control group. By day 30, 70 of 205 patients (34.1%) in the prone positioning group were intubated vs 79 of 195 patients (40.5%) in the control group (hazard ratio, 0.81 [95% CI, 0.59 to 1.12], P = .20; absolute difference, -6.37% [95% CI, -15.83% to 3.10%]). Prone positioning did not significantly reduce mortality at 60 days (hazard ratio, 0.93 [95% CI, 0.62 to 1.40], P = .54; absolute difference, -1.15% [95% CI, -9.40% to 7.10%]) and had no significant effect on days free from invasive mechanical ventilation or noninvasive ventilation at 30 days or on days free from the intensive care unit or hospital at 60 days. There were no serious adverse events in either group. In the awake prone positioning group, 21 patients (10%) experienced adverse events and the most frequently reported were musculoskeletal pain or discomfort from prone positioning (13 of 205 patients [6.34%]) and desaturation (2 of 205 patients [0.98%]). There were no reported adverse events in the control group. Conclusions and Relevance: In patients with acute hypoxemic respiratory failure from COVID-19, prone positioning, compared with usual care without prone positioning, did not significantly reduce endotracheal intubation at 30 days. However, the effect size for the primary study outcome was imprecise and does not exclude a clinically important benefit. Trial Registration: ClinicalTrials.gov Identifier: NCT04350723.
Importance: The efficacy and safety of prone positioning is unclear in nonintubated patients with acute hypoxemia and COVID-19. Objective: To evaluate the efficacy and adverse events of prone positioning in nonintubated adult patients with acute hypoxemia and COVID-19. Design, Setting, and Participants: Pragmatic, unblinded randomized clinical trial conducted at 21 hospitals in Canada, Kuwait, Saudi Arabia, and the US. Eligible adult patients with COVID-19 were not intubated and required oxygen (≥40%) or noninvasive ventilation. A total of 400 patients were enrolled between May 19, 2020, and May 18, 2021, and final follow-up was completed in July 2021. Intervention: Patients were randomized to awake prone positioning (n = 205) or usual care without prone positioning (control; n = 195). Main Outcomes and Measures: The primary outcome was endotracheal intubation within 30 days of randomization. The secondary outcomes included mortality at 60 days, days free from invasive mechanical ventilation or noninvasive ventilation at 30 days, days free from the intensive care unit or hospital at 60 days, adverse events, and serious adverse events. Results: Among the 400 patients who were randomized (mean age, 57.6 years [SD, 12.83 years]; 117 [29.3%] were women), all (100%) completed the trial. In the first 4 days after randomization, the median duration of prone positioning was 4.8 h/d (IQR, 1.8 to 8.0 h/d) in the awake prone positioning group vs 0 h/d (IQR, 0 to 0 h/d) in the control group. By day 30, 70 of 205 patients (34.1%) in the prone positioning group were intubated vs 79 of 195 patients (40.5%) in the control group (hazard ratio, 0.81 [95% CI, 0.59 to 1.12], P = .20; absolute difference, -6.37% [95% CI, -15.83% to 3.10%]). Prone positioning did not significantly reduce mortality at 60 days (hazard ratio, 0.93 [95% CI, 0.62 to 1.40], P = .54; absolute difference, -1.15% [95% CI, -9.40% to 7.10%]) and had no significant effect on days free from invasive mechanical ventilation or noninvasive ventilation at 30 days or on days free from the intensive care unit or hospital at 60 days. There were no serious adverse events in either group. In the awake prone positioning group, 21 patients (10%) experienced adverse events and the most frequently reported were musculoskeletal pain or discomfort from prone positioning (13 of 205 patients [6.34%]) and desaturation (2 of 205 patients [0.98%]). There were no reported adverse events in the control group. Conclusions and Relevance: In patients with acute hypoxemic respiratory failure from COVID-19, prone positioning, compared with usual care without prone positioning, did not significantly reduce endotracheal intubation at 30 days. However, the effect size for the primary study outcome was imprecise and does not exclude a clinically important benefit. Trial Registration: ClinicalTrials.gov Identifier: NCT04350723.
Authors: Waleed Alhazzani; Laura Evans; Fayez Alshamsi; Morten Hylander Møller; Marlies Ostermann; Hallie C Prescott; Yaseen M Arabi; Mark Loeb; Michelle Ng Gong; Eddy Fan; Simon Oczkowski; Mitchell M Levy; Lennie Derde; Amy Dzierba; Bin Du; Flavia Machado; Hannah Wunsch; Mark Crowther; Maurizio Cecconi; Younsuck Koh; Lisa Burry; Daniel S Chertow; Wojciech Szczeklik; Emilie Belley-Cote; Massimiliano Greco; Malgorzata Bala; Ryan Zarychanski; Jozef Kesecioglu; Allison McGeer; Leonard Mermel; Manoj J Mammen; Sheila Nainan Myatra; Amy Arrington; Ruth Kleinpell; Giuseppe Citerio; Kimberley Lewis; Elizabeth Bridges; Ziad A Memish; Naomi Hammond; Frederick G Hayden; Muhammed Alshahrani; Zainab Al Duhailib; Greg S Martin; Lewis J Kaplan; Craig M Coopersmith; Massimo Antonelli; Andrew Rhodes Journal: Crit Care Med Date: 2021-03-01 Impact factor: 7.598
Authors: Stacy A Johnson; Devin J Horton; Matthew J Fuller; Jane Yee; Nijat Aliyev; Jonathan P Boltax; Jefferson H Chambers; Michael J Lanspa Journal: Ann Am Thorac Soc Date: 2021-08
Authors: Shadman Aziz; Yaseen M Arabi; Waleed Alhazzani; Laura Evans; Giuseppe Citerio; Katherine Fischkoff; Jorge Salluh; Geert Meyfroidt; Fayez Alshamsi; Simon Oczkowski; Elie Azoulay; Amy Price; Lisa Burry; Amy Dzierba; Andrew Benintende; Jill Morgan; Giacomo Grasselli; Andrew Rhodes; Morten H Møller; Larry Chu; Shelly Schwedhelm; John J Lowe; Du Bin; Michael D Christian Journal: Intensive Care Med Date: 2020-06-08 Impact factor: 41.787
Authors: Naoka Murakami; Robert Hayden; Thomas Hills; Hanny Al-Samkari; Jonathan Casey; Lorenzo Del Sorbo; Patrick R Lawler; Meghan E Sise; David E Leaf Journal: Nat Rev Nephrol Date: 2022-10-17 Impact factor: 42.439