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

被引:91
作者
Alhazzani, Waleed [1 ,2 ,3 ,4 ]
Parhar, Ken Kuljit S. [5 ,6 ,7 ,8 ]
Weatherald, Jason [7 ,8 ,9 ,10 ]
Al Duhailib, Zainab [11 ,12 ]
Alshahrani, Mohammed [13 ]
Al-Fares, Abdulrahman [14 ]
Buabbas, Sarah [15 ]
Cherian, Sujith, V [16 ,17 ,18 ]
Munshi, Laveena [19 ,20 ]
Fan, Eddy [19 ,20 ]
Al-Hameed, Fahad [21 ,22 ]
Chalabi, Jamal [23 ,24 ]
Rahmatullah, Amera A. [11 ]
Duan, Erick [1 ,2 ,4 ,25 ]
Tsang, Jennifer L. Y. [1 ,25 ]
Lewis, Kimberley [1 ,4 ]
Lauzier, Francois [26 ,27 ]
Centofanti, John [28 ]
Rochwerg, Bram [1 ,2 ]
Culgin, Sarah [4 ]
Nelson, Katlynne [4 ]
Abdukahil, Sheryl Ann [29 ,30 ,31 ]
Fiest, Kirsten M. [5 ,6 ,32 ,33 ,34 ,35 ]
Stelfox, Henry T. [5 ,6 ,32 ,33 ]
Tlayjeh, Haytham [29 ,30 ,31 ]
Meade, Maureen O. [1 ,2 ]
Perri, Dan [1 ,4 ]
Solverson, Kevin [5 ,6 ,9 ]
Niven, Daniel J. [5 ,6 ]
Lim, Rachel [9 ]
Moller, Morten Hylander [36 ]
Belley-Cote, Emilie [1 ,37 ]
Thabane, Lehana [2 ,4 ]
Tamim, Hani [12 ,38 ]
Cook, Deborah J. [1 ,2 ,4 ]
Arabi, Yaseen M. [29 ,30 ,31 ]
机构
[1] McMaster Univ, Dept Med, 1200 Main St W, Hamilton, ON L8N 3Z5, Canada
[2] McMaster Univ, Dept Hlth Res Methods Evidence & Impact, 1200 Main St W, Hamilton, ON L8N 3Z5, Canada
[3] King Saud Univ, Coll Med, Dept Crit Care, Riyadh, Saudi Arabia
[4] St Josephs Healthcare Hamilton, Res Inst, Hamilton, ON, Canada
[5] Alberta Hlth Serv, Dept Crit Care Med, Calgary, AB, Canada
[6] Univ Calgary, Calgary, AB, Canada
[7] Univ Calgary, Libin Cardiovasc Inst, Calgary, AB, Canada
[8] OBrien Inst Publ Hlth, Calgary, AB, Canada
[9] Univ Calgary, Dept Med, Div Respirol, Calgary, AB, Canada
[10] Univ Alberta, Dept Med, Div Pulm Med, Edmonton, AB, Canada
[11] King Faisal Specialist Hosp & Res Ctr, Crit Care Med Dept, Riyadh, Saudi Arabia
[12] Alfaisal Univ, Coll Med, Riyadh, Saudi Arabia
[13] Imam Abdulrahman Bin Faisal Univ, Dept Emergency & Crit Care, Dammam, Saudi Arabia
[14] Al Amiri Hosp, Dept Anesthesia Crit Care Med & Pain Med, Kuwait, Kuwait
[15] Jaber Al Ahmad Al Sabah Hosp, Dept Anesthesia Crit Care Med & Pain Med, Kuwait, Kuwait
[16] Univ Texas Hlth McGovern Med Sch, Dept Internal Med, Div Crit Care, Houston, TX USA
[17] Univ Texas Hlth McGovern Med Sch, Dept Internal Med, Div Pulm, Houston, TX USA
[18] Univ Texas Hlth McGovern Med Sch, Dept Internal Med, Div Sleep Med, Houston, TX USA
[19] Univ Toronto, Interdept Div Crit Care, Toronto, ON, Canada
[20] Univ Hlth Network, Toronto, ON, Canada
[21] King Saud Bin Abdulaziz Univ Hlth Sci, Coll Med, Dept Intens Care, Jeddah, Saudi Arabia
[22] King Abdul Aziz Med City, King Abdullah Int Med Res Ctr, Jeddah, Saudi Arabia
[23] Minist Natl Guard Hlth Affairs, Intens Care Dept, Al Hasa, Saudi Arabia
[24] King Saud Bin Abdulaziz Univ Hlth Sci, King Abdullah Int Med Res Ctr, Al Hasa, Saudi Arabia
[25] Niagara Hlth, Div Crit Care, St Catharines, ON, Canada
[26] Univ Laval, Dept Med, Quebec City, PQ, Canada
[27] Univ Laval, Dept Anesthesiol & Crit Care, Div Crit Care, Quebec City, PQ, Canada
[28] McMaster Univ, Dept Anesthesia, Hamilton, ON, Canada
[29] King Saud Bin Abdulaziz Univ Hlth Sci, Coll Med, Riyadh, Saudi Arabia
[30] King Abdullah Int Med Res Ctr, Riyadh, Saudi Arabia
[31] Minist Natl Guard Hlth Affairs, Intens Care Dept, King Abdulaziz Med City, Riyadh, Saudi Arabia
[32] Univ Calgary, Dept Community Hlth Sci, Calgary, AB, Canada
[33] Univ Calgary, OBrien Inst Publ Hlth, Calgary, AB, Canada
[34] Univ Calgary, Cumming Sch Med, Dept Psychiat, Calgary, AB, Canada
[35] Univ Calgary, Hotchkiss Brain Inst, Cumming Sch Med, Calgary, AB, Canada
[36] Copenhagen Univ Hosp, Dept Intens Care, Rigshosp, Copenhagen, Denmark
[37] Populat Hlth Res Inst, Hamilton, ON, Canada
[38] Amer Univ Beirut, Dept Emergency Med, Beirut, Lebanon
来源
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 2022年 / 327卷 / 21期
关键词
DISTRESS-SYNDROME;
D O I
10.1001/jama.2022.7993
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 dinically important benefit. (C) 2022 American Medical Association. All rights reserved.
引用
收藏
页码:2104 / 2113
页数:10
相关论文
共 24 条
[1]   Surviving Sepsis Campaign Guidelines on the Management of Adults With Coronavirus Disease 2019 (COVID-19) in the ICU: First Update [J].
Alhazzani, Waleed ;
Evans, Laura ;
Alshamsi, Fayez ;
Moller, Morten Hylander ;
Ostermann, Marlies ;
Prescott, Hallie C. ;
Arabi, Yaseen M. ;
Loeb, Mark ;
Gong, Michelle Ng ;
Fan, Eddy ;
Oczkowski, Simon ;
Levy, Mitchell M. ;
Derde, Lennie ;
Dzierba, Amy ;
Du, Bin ;
Machado, Flavia ;
Wunsch, Hannah ;
Crowther, Mark ;
Cecconi, Maurizio ;
Koh, Younsuck ;
Burry, Lisa ;
Chertow, Daniel S. ;
Szczeklik, Wojciech ;
Belley-Cote, Emilie ;
Greco, Massimiliano ;
Bala, Malgorzata ;
Zarychanski, Ryan ;
Kesecioglu, Jozef ;
McGeer, Allison ;
Mermel, Leonard ;
Mammen, Manoj J. ;
Myatra, Sheila Nainan ;
Arrington, Amy ;
Kleinpell, Ruth ;
Citerio, Giuseppe ;
Lewis, Kimberley ;
Bridges, Elizabeth ;
Memish, Ziad A. ;
Hammond, Naomi ;
Hayden, Frederick G. ;
Alshahrani, Muhammed ;
Al Duhailib, Zainab ;
Martin, Greg S. ;
Kaplan, Lewis J. ;
Coopersmith, Craig M. ;
Antonelli, Massimo ;
Rhodes, Andrew .
CRITICAL CARE MEDICINE, 2021, 49 (03) :E219-E234
[2]   Managing ICU surge during the COVID-19 crisis: rapid guidelines [J].
Aziz, Shadman ;
Arabi, Yaseen M. ;
Alhazzani, Waleed ;
Evans, Laura ;
Citerio, Giuseppe ;
Fischkoff, Katherine ;
Salluh, Jorge ;
Meyfroidt, Geert ;
Alshamsi, Fayez ;
Oczkowski, Simon ;
Azoulay, Elie ;
Price, Amy ;
Burry, Lisa ;
Dzierba, Amy ;
Benintende, Andrew ;
Morgan, Jill ;
Grasselli, Giacomo ;
Rhodes, Andrew ;
Moller, Morten H. ;
Chu, Larry ;
Schwedhelm, Shelly ;
Lowe, John J. ;
Bin, Du ;
Christian, Michael D. .
INTENSIVE CARE MEDICINE, 2020, 46 (07) :1303-1325
[3]  
Duhailib ZA., 2021, MEDRXIV, DOI [10.1101/2021.08.06.21261531, DOI 10.1101/2021.08.06.21261531]
[4]   Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial [J].
Ehrmann, Stephan ;
Li, Jie ;
Ibarra-Estrada, Miguel ;
Perez, Yonatan ;
Pavlov, Ivan ;
McNicholas, Bairbre ;
Roca, Oriol ;
Mirza, Sara ;
Vines, David ;
Garcia-Salcido, Roxana ;
Aguirre-Avalos, Guadalupe ;
Trump, Matthew W. ;
Nay, Mai-Anh ;
Dellamonica, Jean ;
Nseir, Saad ;
Mogri, Idrees ;
Cosgrave, David ;
Jayaraman, Dev ;
Masclans, Joan R. ;
Laffey, John G. ;
Tavernier, Elsa .
LANCET RESPIRATORY MEDICINE, 2021, 9 (12) :1387-1395
[5]   Prone positioning for non-intubated spontaneously breathing patients with acute hypoxaemic respiratory failure: a systematic review and meta-analysis [J].
Fazzini, Brigitta ;
Page, Alexandria ;
Pearse, Rupert ;
Puthucheary, Zudin .
BRITISH JOURNAL OF ANAESTHESIA, 2022, 128 (02) :352-362
[6]   Awake prone positioning versus non invasive ventilation for COVID-19 patients with acute hypoxemic respiratory failure [J].
Gad, Gad S. .
EGYPTIAN JOURNAL OF ANAESTHESIA, 2021, 37 (01) :85-90
[7]   Physiologic rationale for ventilator setting in acute lung injury/acute respiratory distress syndrome patients [J].
Gattinoni, L ;
Vagginelli, F ;
Chiumello, D ;
Taccone, P ;
Carlesso, E .
CRITICAL CARE MEDICINE, 2003, 31 (04) :S300-S304
[8]   False discovery rate control is a recommended alternative to Bonferroni-type adjustments in health studies [J].
Glickman, Mark E. ;
Rao, Sowmya R. ;
Schultz, Mark R. .
JOURNAL OF CLINICAL EPIDEMIOLOGY, 2014, 67 (08) :850-857
[9]   Critical Care Utilization for the COVID-19 Outbreak in Lombardy, Italy Early Experience and Forecast During an Emergency Response [J].
Grasselli, Giacomo ;
Pesenti, Antonio ;
Cecconi, Maurizio .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2020, 323 (16) :1545-1546
[10]   Prone Positioning in Severe Acute Respiratory Distress Syndrome [J].
Guerin, Claude ;
Reignier, Jean ;
Richard, Jean-Christophe ;
Beuret, Pascal ;
Gacouin, Arnaud ;
Boulain, Thierry ;
Mercier, Emmanuelle ;
Badet, Michel ;
Mercat, Alain ;
Baudin, Olivier ;
Clavel, Marc ;
Chatellier, Delphine ;
Jaber, Samir ;
Rosselli, Sylvene ;
Mancebo, Jordi ;
Sirodot, Michel ;
Hilbert, Gilles ;
Bengler, Christian ;
Richecoeur, Jack ;
Gainnier, Marc ;
Bayle, Frederique ;
Bourdin, Gael ;
Leray, Veronique ;
Girard, Raphaele ;
Baboi, Loredana ;
Ayzac, Louis .
NEW ENGLAND JOURNAL OF MEDICINE, 2013, 368 (23) :2159-2168