Effect of Awake Prone Positioning on Endotracheal Intubation in Patients With COVID-19 and Acute Respiratory Failure: A Randomized Clinical Trial

doi:10.1001/jama.2022.7993

Randomized Controlled Trial

. 2022 Jun 7;327(21):2104-2113.

doi: 10.1001/jama.2022.7993.

Effect of Awake Prone Positioning on Endotracheal Intubation in Patients With COVID-19 and Acute Respiratory Failure: A Randomized Clinical Trial

Waleed Alhazzani^{1

2

3

4}, Ken Kuljit S Parhar^{5

6

7}, Jason Weatherald^{6

7

8

9}, Zainab Al Duhailib^{10

11}, Mohammed Alshahrani¹², Abdulrahman Al-Fares¹³, Sarah Buabbas¹⁴, Sujith V Cherian¹⁵, Laveena Munshi^{16

17}, Eddy Fan^{16

17}, Fahad Al-Hameed^{18

19}, Jamal Chalabi^{20

21}, Amera A Rahmatullah¹⁰, Erick Duan^{1

2

4

22}, Jennifer L Y Tsang^{1

22}, Kimberley Lewis^{1

4}, François Lauzier^{23

24}, John Centofanti²⁵, Bram Rochwerg^{1

2}, Sarah Culgin⁴, Katlynne Nelson⁴, Sheryl Ann Abdukahil^{26

27

28}, Kirsten M Fiest^{5

29

30}, Henry T Stelfox^{5

29}, Haytham Tlayjeh^{26

27

28}, Maureen O Meade^{1

2}, Dan Perri^{1

4}, Kevin Solverson^{5

8}, Daniel J Niven⁵, Rachel Lim⁸, Morten Hylander Møller³¹, Emilie Belley-Cote^{1

32}, Lehana Thabane^{2

4}, Hani Tamim^{11

33}, Deborah J Cook^{1

2

4}, Yaseen M Arabi^{26

27

28}; COVI-PRONE Trial Investigators and the Saudi Critical Care Trials Group

Collaborators, Affiliations

Collaborators

COVI-PRONE Trial Investigators and the Saudi Critical Care Trials Group:
Kara Nerenberg, Alexis Turgeon, Charles Francoeur, Guillaume Leblanc, Maude St-Onge, Lorenzo Del Sorbo, Rosa M Estrada-Y-Martin, Hala Hamada, Abdulaziz Al-Mutawa, Ardeshir Algooneh, Farhan Alenezi, Eman Al Qasim, Hussain Al Haji, Mohammad Al Mutairi, Omar Zumai, Amal Matroud, Musharaf Sadat, Felwa Bin Humaid, Wedyan Al Wehaibi, Faisal Al-Basseet, Mohammed Alobaidi, Muhammed Alshahrani, Yousef Almubarak, Laila Perlas Asonto, Charlene Mapusao, Katherine Cruz, Arivu Muthu, Shaya Y AlQahtani, Mae Ann Santillan, Amera Rahmatullah, Shatha Baraja'a, Haya Al Othaimeen, Fahad Al-Hameed, Gulam Rasool, Ohoud Alorabi, Gauhar Khan, Jamal Chalabi, Zuheb Nagoor, Ammar Alkroud, Arwa Alhussaini, Ahmad Qureshi, Ahmad Quadri, Babar Javed, Khalid Idrees

Affiliations

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.

PMID: 35569448
PMCID: PMC9108999
DOI: 10.1001/jama.2022.7993

Randomized Controlled Trial

Effect of Awake Prone Positioning on Endotracheal Intubation in Patients With COVID-19 and Acute Respiratory Failure: A Randomized Clinical Trial

Waleed Alhazzani et al. JAMA. 2022.

. 2022 Jun 7;327(21):2104-2113.

doi: 10.1001/jama.2022.7993.

Authors

Collaborators

COVI-PRONE Trial Investigators and the Saudi Critical Care Trials Group:
Kara Nerenberg, Alexis Turgeon, Charles Francoeur, Guillaume Leblanc, Maude St-Onge, Lorenzo Del Sorbo, Rosa M Estrada-Y-Martin, Hala Hamada, Abdulaziz Al-Mutawa, Ardeshir Algooneh, Farhan Alenezi, Eman Al Qasim, Hussain Al Haji, Mohammad Al Mutairi, Omar Zumai, Amal Matroud, Musharaf Sadat, Felwa Bin Humaid, Wedyan Al Wehaibi, Faisal Al-Basseet, Mohammed Alobaidi, Muhammed Alshahrani, Yousef Almubarak, Laila Perlas Asonto, Charlene Mapusao, Katherine Cruz, Arivu Muthu, Shaya Y AlQahtani, Mae Ann Santillan, Amera Rahmatullah, Shatha Baraja'a, Haya Al Othaimeen, Fahad Al-Hameed, Gulam Rasool, Ohoud Alorabi, Gauhar Khan, Jamal Chalabi, Zuheb Nagoor, Ammar Alkroud, Arwa Alhussaini, Ahmad Qureshi, Ahmad Quadri, Babar Javed, Khalid Idrees

Affiliations

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.

PMID: 35569448
PMCID: PMC9108999
DOI: 10.1001/jama.2022.7993

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.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Dr Parhar reported receiving Rapid COVID-19 grants from the Cumming School of Medicine at the University of Calgary and Alberta Innovates. Dr Weatherald reported receiving Rapid COVID-19 grants from the Cumming School of Medicine at the University of Calgary; receiving grants, personal fees, and nonfinancial support from Janssen, Actelion, and Bayer; and receiving personal fees from Acceleron and Merck. Dr Alshahrani reported receiving grants from King Abdullah International Medical Research Center. Dr Fan reported receiving personal fees from ALung Technologies, Baxter, Aerogen, Inspira, GE Healthcare, and Vasomune. Dr Belley-Cote reported receiving grants from Bayer, Bristol Myers Squibb-Pfizer Alliance, and Roche Diagnostics. No other disclosures were reported.

Figures

**Figure 1.. Screening, Enrollment, Randomization, and Inclusion in Analysis in the COVI-PRONE Trial**
COVI-PRONE, Awake Prone Position in Hypoxemic Patients with Coronavirus Disease 19. ^aNo data were collected on screened patients found to be ineligible. ^bCentral web-based randomization stratified by hospital and by ratio of oxygen saturation as measured by pulse oximetry to fraction of inspired oxygen of greater than 150 or of 150 or less.

**Figure 2.. Duration of Awake Prone Positioning by Study Group**
The box plots display the median duration of prone positioning. The line represents the median, the box edges represent the first and third quartiles, the whiskers represent the most extreme values up to 1.5 × IQR, and the dots represent the more extreme values.

**Figure 3.. Kaplan-Meier Survival Curves for Endotracheal Intubation Within 30 Days of Randomization and Mortality at 60 Days**
A, The log-rank test did not demonstrate a significant between-group difference (P = .19). The median time of observation was 30 days (IQR, 7-30 days) in the awake prone positioning group and 30 days (IQR, 5-30 days) in the control group. B, The log-rank test did not demonstrate a significant between-group difference (P = .72). In both groups, the median time of observation was 60 days (IQR, 60-60 days).

See this image and copyright information in PMC

Comment in

In COVID-19 acute hypoxemia, awake prone positioning vs. usual care did not reduce intubation at 30 d.
Agarwal A, Martin GS. Agarwal A, et al. Ann Intern Med. 2022 Sep;175(9):JC99. doi: 10.7326/J22-0068. Epub 2022 Sep 6. Ann Intern Med. 2022. PMID: 36063555 Free PMC article.
Effect of Awake Prone Positioning on Patients With COVID-19 and Acute Respiratory Failure.
Raghunathan K, Raghunathan A. Raghunathan K, et al. JAMA. 2022 Oct 4;328(13):1354. doi: 10.1001/jama.2022.13991. JAMA. 2022. PMID: 36194223 No abstract available.
Effect of Awake Prone Positioning on Patients With COVID-19 and Acute Respiratory Failure.
Gershengorn HB. Gershengorn HB. JAMA. 2022 Oct 4;328(13):1353-1354. doi: 10.1001/jama.2022.13988. JAMA. 2022. PMID: 36194224 No abstract available.

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References

1. Grasselli G, Pesenti A, Cecconi M. Critical care utilization for the COVID-19 outbreak in Lombardy, Italy: early experience and forecast during an emergency response. JAMA. 2020;323(16):1545-1546. doi:10.1001/jama.2020.4031 - DOI - PubMed
1. Pal R, Yadav U. COVID-19 pandemic in India: present scenario and a steep climb ahead. J Prim Care Community Health. 2020;11:2150132720939402. doi:10.1177/2150132720939402 - DOI - PMC - PubMed
1. Aziz S, Arabi YM, Alhazzani W, et al. . Managing ICU surge during the COVID-19 crisis: rapid guidelines. Intensive Care Med. 2020;46(7):1303-1325. doi:10.1007/s00134-020-06092-5 - DOI - PMC - PubMed
1. Piehl MA, Brown RS. Use of extreme position changes in acute respiratory failure. Crit Care Med. 1976;4(1):13-14. doi:10.1097/00003246-197601000-00003 - DOI - PubMed
1. Malbouisson LM, Busch CJ, Puybasset L, Lu Q, Cluzel P, Rouby JJ; CT Scan ARDS Study Group . Role of the heart in the loss of aeration characterizing lower lobes in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2000;161(6):2005-2012. doi:10.1164/ajrccm.161.6.9907067 - DOI - PubMed

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[1] Grasselli G, Pesenti A, Cecconi M. Critical care utilization for the COVID-19 outbreak in Lombardy, Italy: early experience and forecast during an emergency response. JAMA. 2020;323(16):1545-1546. doi:10.1001/jama.2020.4031 - DOI - PubMed

[2] Grasselli G, Pesenti A, Cecconi M. Critical care utilization for the COVID-19 outbreak in Lombardy, Italy: early experience and forecast during an emergency response. JAMA. 2020;323(16):1545-1546. doi:10.1001/jama.2020.4031 - DOI - PubMed

[3] Pal R, Yadav U. COVID-19 pandemic in India: present scenario and a steep climb ahead. J Prim Care Community Health. 2020;11:2150132720939402. doi:10.1177/2150132720939402 - DOI - PMC - PubMed

[4] Pal R, Yadav U. COVID-19 pandemic in India: present scenario and a steep climb ahead. J Prim Care Community Health. 2020;11:2150132720939402. doi:10.1177/2150132720939402 - DOI - PMC - PubMed

[5] Aziz S, Arabi YM, Alhazzani W, et al. . Managing ICU surge during the COVID-19 crisis: rapid guidelines. Intensive Care Med. 2020;46(7):1303-1325. doi:10.1007/s00134-020-06092-5 - DOI - PMC - PubMed

[6] Aziz S, Arabi YM, Alhazzani W, et al. . Managing ICU surge during the COVID-19 crisis: rapid guidelines. Intensive Care Med. 2020;46(7):1303-1325. doi:10.1007/s00134-020-06092-5 - DOI - PMC - PubMed

[7] Piehl MA, Brown RS. Use of extreme position changes in acute respiratory failure. Crit Care Med. 1976;4(1):13-14. doi:10.1097/00003246-197601000-00003 - DOI - PubMed

[8] Piehl MA, Brown RS. Use of extreme position changes in acute respiratory failure. Crit Care Med. 1976;4(1):13-14. doi:10.1097/00003246-197601000-00003 - DOI - PubMed

[9] Malbouisson LM, Busch CJ, Puybasset L, Lu Q, Cluzel P, Rouby JJ; CT Scan ARDS Study Group . Role of the heart in the loss of aeration characterizing lower lobes in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2000;161(6):2005-2012. doi:10.1164/ajrccm.161.6.9907067 - DOI - PubMed

[10] Malbouisson LM, Busch CJ, Puybasset L, Lu Q, Cluzel P, Rouby JJ; CT Scan ARDS Study Group . Role of the heart in the loss of aeration characterizing lower lobes in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2000;161(6):2005-2012. doi:10.1164/ajrccm.161.6.9907067 - DOI - PubMed

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Effect of Awake Prone Positioning on Endotracheal Intubation in Patients With COVID-19 and Acute Respiratory Failure: A Randomized Clinical Trial

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Effect of Awake Prone Positioning on Endotracheal Intubation in Patients With COVID-19 and Acute Respiratory Failure: A Randomized Clinical Trial

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