https://doi.org/10.4081/monaldi.2022.2431
Effectiveness of early awake self proning strategy in non-intubated patients with COVID-19 hypoxemia: an open-labelled randomized clinical trial from Jodhpur, India
Submitted: September 9, 2022
Accepted: December 5, 2022
Published: December 16, 2022
Accepted: December 5, 2022
Abstract Views: 1501
PDF: 396
Supplementary: 132
Supplementary 2_Ethics-Trial: 90
Supplementary 3-CONSORT Checklist: 127
Supplementary 4-Ministry of Health and Family Welfare handout: 91
Supplementary: 132
Supplementary 2_Ethics-Trial: 90
Supplementary 3-CONSORT Checklist: 127
Supplementary 4-Ministry of Health and Family Welfare handout: 91
Publisher's note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
Authors
Awake self-proning is being used widely as respiratory support in COVID-19 hypoxemia, in resource-limited settings. We aimed to investigate the effectiveness of early awake self-proning in preventing mortality and the need for intubation in adults with moderate COVID-19 hypoxemia. In this randomized clinical trial with intention-to-treat analysis, we enrolled eligible adults with COVID-19 hypoxemia (SpO2 <94%), requiring supplemental oxygen via nasal prongs or facemask from a tertiary-care setting in Jodhpur, India between June 15 to December 24, 2020. Awake proning comprised of 4-hour cycles with prone position maintained 2 h per cycle. The control group did not maintain any specific position. All participants received standard care. The primary outcomes were 30-day mortality and requirement for mechanical ventilation. Of 502 participants included, mean (SD) age was 59.7 (12.7) years with 124 women (24.6%); 257 were randomized to awake-proning, 245 to control group and all 502 were included for follow-up mortality analysis. Mortality at follow-up was 16.3% in the awake-prone and 15.1% in the control group [OR:1.10 (0.68-1.78), p=0.703). The requirement of mechanical ventilation was 10% in both groups (p=0.974). Survival time (in days) was not significantly different between the groups [Log-rank test, HR: 1.08 (95% CI, 0.70-1.68), p=0.726]. Likewise, time to intubation was comparable (Log-rank test, HR: 0.93 (95% CI, 0.56-1.70), p=0.974). Hence, awake self-proning did not improve survival or requirement of mechanical-ventilation in non-intubated patients with mild to moderate COVID-19 hypoxemia. Trial Registration: Clinical trial registry of India, ID: CTRI/2020/06/025804.
The trial is accessible from WHO's International Clinical Trials Registry Platform (ICTRP) at https://trialsearch.who.int
***************************************************************
*Appendix Authors list
Deepak Kumar1, Gopal Krishna Bohra1, Nishant Kumar Chauhan2, Nikhil Kothari3, Vijaya Lakshmi Nag4 Sanjeev Misra5
1Department of Internal Medicine; 2Department of Pulmonary Medicine; 3Department of Anaesthesiology and Critical Care; 4Department of Microbiology; 5Department of Surgical Oncology, All India Institute of Medical Sciences, Jodhpur, India
Osuchowski MF, Winkler MS, Skirecki T, et al. The COVID-19 puzzle: deciphering pathophysiology and phenotypes of a new disease entity. Lancet Respir Med 2021;9:622–42.
DOI: https://doi.org/10.1016/S2213-2600(21)00218-6
Wiersinga WJ, Rhodes A, Cheng AC, et al. Pathophysiology, transmission, diagnosis, and treatment of coronavirus disease 2019 (COVID-19): A review. JAMA 2020;324:782–93.
DOI: https://doi.org/10.1001/jama.2020.12839
Grieco DL, Menga LS, Cesarano M, et al. Effect of Helmet noninvasive ventilation vs high-flow nasal oxygen on days free of respiratory support in patients with COVID-19 and moderate to severe hypoxemic respiratory failure: The HENIVOT randomized clinical trial. JAMA 2021;325:1731–43.
DOI: https://doi.org/10.1001/jama.2021.4682
Carter C, Aedy H, Notter J. COVID-19 disease: Non-invasive ventilation and high frequency nasal oxygenation. Clin Integr Care 2020;1:100006.
DOI: https://doi.org/10.1016/j.intcar.2020.100006
Hallifax RJ, Porter BM, Elder PJ, et al. Successful awake proning is associated with improved clinical outcomes in patients with COVID-19: single-centre high-dependency unit experience. BMJ Open Respir Res 2020;7:e000678.
DOI: https://doi.org/10.1136/bmjresp-2020-000678
Perez-Nieto OR, Escarraman-Martinez D, Guerrero-Gutierrez MA, et al. Awake prone positioning and oxygen therapy in patients with COVID-19: The APRONOX study. Eur Respir J 2021;2100265.
DOI: https://doi.org/10.1101/2021.01.27.21250631
Scholten EL, Beitler JR, Prisk GK, Malhotra A. Treatment of ARDS with prone positioning. Chest 2017;151:215–24.
DOI: https://doi.org/10.1016/j.chest.2016.06.032
Kallet RH. A comprehensive review of prone position in ARDS. Respir Care 2015;60:1660–87.
DOI: https://doi.org/10.4187/respcare.04271
Coppo A, Bellani G, Winterton D, et al. Feasibility and physiological effects of prone positioning in non-intubated patients with acute respiratory failure due to COVID-19 (PRON-COVID): a prospective cohort study. Lancet Respir Med 2020;8:765–74.
DOI: https://doi.org/10.1016/S2213-2600(20)30268-X
Stilma W, Åkerman E, Artigas A, et al. Awake Proning as an adjunctive therapy for refractory hypoxemia in non-intubated patients with COVID-19 acute respiratory failure: Guidance from an International group of healthcare workers. Am J Trop Med Hyg 2021;104:1676–86.
DOI: https://doi.org/10.4269/ajtmh.20-1445
Ministry of Health and Family Welfare [Internet]. Resources for COVID-19. COVID-19 proning for self care. Available from: https://www.mohfw.gov.in/
Kharat A, Simon M, Guérin C. Prone position in COVID 19-associated acute respiratory failure. Curr Opin Crit Care 2022;28:57–65.
DOI: https://doi.org/10.1097/MCC.0000000000000900
Fazzini B, Page A, Pearse R, Puthucheary Z. Prone positioning for non-intubated spontaneously breathing patients with acute hypoxaemic respiratory failure: a systematic review and meta-analysis. Br J Anaesth 2022;128:352–62.
DOI: https://doi.org/10.1016/j.bja.2021.09.031
Fralick M, Colacci M, Munshi L, et al. Prone positioning of patients with moderate hypoxaemia due to covid-19: multicentre pragmatic randomised trial (COVID-PRONE). BMJ 2022;376:e068585.
DOI: https://doi.org/10.1136/bmj-2021-068585
Qian ET, Gatto CL, Amusina O, et al. Assessment of awake prone positioning in hospitalized adults with COVID-19: A nonrandomized controlled trial. JAMA Intern Med 2022;182:612–21.
DOI: https://doi.org/10.1001/jamainternmed.2022.3112
Ehrmann S, Li J, Ibarra-Estrada M, Perez Y, et al. Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial. Lancet Respir Med 2021;9:1387-95.
DOI: https://doi.org/10.1016/S2213-2600(21)00356-8
Alhazzani W, Parhar KKS, Weatherald J, Al Duhailib Z, Alshahrani M, Al-Fares A, et al. Effect of awake prone positioning on endotracheal intubation in patients with COVID-19 and acute respiratory failure: A randomized clinical trial. JAMA 2022;327:2104–13.
DOI: https://doi.org/10.1001/jama.2022.13994
Johnson NJ, Luks AM, Glenny RW. Gas exchange in the prone posture. Respir Care 2017;62:1097-110.
DOI: https://doi.org/10.4187/respcare.05512
Pb S, Mittal S, Madan K, et al. Awake prone positioning in non-intubated patients for the management of hypoxemia in COVID-19: A systematic review and meta-analysis. Monaldi Arch Chest Dis 2021;91:1623.
DOI: https://doi.org/10.4081/monaldi.2021.1623
Richardson S, Hirsch JS, Narasimhan M, et al. Presenting characteristics, comorbidities, and outcomes among 5700 patients hospitalized with COVID-19 in the New York City area. JAMA 2020;323:2052–9.
DOI: https://doi.org/10.1001/jama.2020.6775
Bower G, He H. Protocol for awake prone positioning in COVID-19 patients: to do it earlier, easier, and longer. Crit Care 2020;24:371.
DOI: https://doi.org/10.1186/s13054-020-03096-x
Ministry of Health and Family Welfare [Internet].| Homepage. Accessed: 2021 Jun 21. Available from: https://www.mohfw.gov.in/
Jayakumar D, Ramachandran P, Rabindrarajan E, et al. Standard care versus awake prone position in adult nonintubated patients with acute hypoxemic respiratory failure secondary to COVID-19 infection-A multicenter feasibility randomized controlled trial. J Intensive Care Med 2021;36:918-24.
DOI: https://doi.org/10.1177/08850666211014480
Johnson SA, Horton DJ, Fuller MJ, et al. Patient-directed prone positioning in awake patients with COVID-19 requiring hospitalization (PAPR). Ann Am Thorac Soc 2021;18:1424–6.
DOI: https://doi.org/10.1513/AnnalsATS.202011-1466RL
Bamford P, Bentley A, Dean J, Wilson-Baig N. ICS guidance for prone positioning of the conscious COVID patient 2020. Intensive Care Society, UK; 2020. Accessed: August 2020. Available from: https://emcrit.org/wp-content/uploads/2020/04/2020-04-12-Guidance-for-conscious-proning.pdf
Coopersmith CM, Antonelli M, Bauer SR, et al. The surviving sepsis campaign: Research priorities for coronavirus disease 2019 in critical illness. Crit Care Med 2021;49:598–622.
DOI: https://doi.org/10.1097/CCM.0000000000004895
Nasa P, Azoulay E, Khanna AK, et al. Expert consensus statements for the management of COVID-19-related acute respiratory failure using a Delphi method. Crit Care 2021;25:106.
DOI: https://doi.org/10.1186/s13054-021-03491-y
Sodhi K, Chanchalani G. Awake proning: Current evidence and practical considerations. Indian J Crit Care Med 2020;24:1236–41.
DOI: https://doi.org/10.5005/jp-journals-10071-23684
Koeckerling D, Barker J, Mudalige NL, et al. Awake prone positioning in COVID-19. Thorax 2020;75:833–4.
DOI: https://doi.org/10.1136/thoraxjnl-2020-215133
Paul V, Patel S, Royse M, et al. Proning in non-intubated (PINI) in times of COVID-19: Case series and a review. J Intensive Care Med 2020;35:818–24.
DOI: https://doi.org/10.1177/0885066620934801
Caputo ND, Strayer RJ, Levitan R. Early self-proning in awake, non-intubated patients in the emergency department: A single ED’s experience during the COVID-19 pandemic. Acad Emerg Med 2020;27:375-8.
DOI: https://doi.org/10.1111/acem.13994
Weatherald J, Norrie J, Parhar KKS. Awake prone positioning in COVID-19: is tummy time ready for prime time? Lancet Respir Med 2021;9:1347–9.
DOI: https://doi.org/10.1016/S2213-2600(21)00368-4
Taylor SP, Bundy H, Smith WM, et al. Awake prone positioning strategy for nonintubated hypoxic patients with COVID-19: A pilot trial with embedded implementation evaluation. Ann Am Thorac Soc 2021;18:1360–8.
DOI: https://doi.org/10.1513/AnnalsATS.202009-1164OC
Bong CL, Brasher C, Chikumba E, et al. The COVID-19 pandemic: Effects on low- and middle-income countries. Anesth Analg 2020;131:86–92.
DOI: https://doi.org/10.1213/ANE.0000000000004846
Klaiman T, Silvestri JA, Srinivasan T, et al. Improving prone positioning for severe acute respiratory distress syndrome during the COVID-19 pandemic. An implementation-mapping approach. Ann Am Thorac Soc 2021;18:300–7.
DOI: https://doi.org/10.1513/AnnalsATS.202005-571OC
Telias I, Katira BH, Brochard L. Is the prone position helpful during spontaneous breathing in patients with COVID-19? JAMA 2020;323:2265–7.
DOI: https://doi.org/10.1001/jama.2020.8539
Ethics Approval
the study was approved by Institute Ethics Committee (AIIMS/IEC/2020-21/2040)., Trial was registered at Clinical trial registry of India, CTRI/2020/06/025804 and is accessible from WHO's International Clinical Trials Registry Platform (ICTRP) at https://trialsearch.who.inHow to Cite
Gopalakrishnan, Maya, Satyendra Khichar, Suman Saurabh, Parag Vijayvergia, Karthikeyan Thangaraju, Swapnil Tripathi, Harshavardhan V. Devarakonda, Akhilesh Kumar, Pranav S. Kumar, and Mahendra Kumar Garg. 2022. “Effectiveness of Early Awake Self Proning Strategy in Non-Intubated Patients With COVID-19 Hypoxemia: An Open-Labelled Randomized Clinical Trial from Jodhpur, India”. Monaldi Archives for Chest Disease 93 (4). https://doi.org/10.4081/monaldi.2022.2431.
Copyright (c) 2022 The Author(s)
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
PAGEPress has chosen to apply the Creative Commons Attribution NonCommercial 4.0 International License (CC BY-NC 4.0) to all manuscripts to be published.
Similar Articles
- Edoardo Sciatti, Enrico Vizzardi, Dario S. Cani, Assunta Castiello, Ivano Bonadei, Daria Savoldi, Marco Metra, Antonio D'Aloia, Kounis syndrome, a disease to know: Case report and review of the literature , Monaldi Archives for Chest Disease: Vol. 88 No. 1 (2018)
- Giorgio E. Polistina, Camilla Di Somma, Martina Flora, Alberto E. Maraolo, Novella Carannante, Gerardo Langella, Angela I. Mirizzi, Anna Annunziata, Giuseppe Fiorentino, Respiratory Intensive Care Unit management and efficacy during the COVID-19 outbreak in Naples, Italy , Monaldi Archives for Chest Disease: Vol. 93 No. 2 (2023)
- Laura Crespi, Monica Bosco, Naika Scalabrino, Massimo Baravelli, Anna Picozzi, Andrea Rossi, Melania Romano, Daniela Imperiale, Silvana Borghi, Elisabetta Brunello, Claudio Anzà , Intensive physiotherapic respiratory care in critically ill patients with tracheostomy after cardiac surgery , Monaldi Archives for Chest Disease: Vol. 72 No. 3 (2009): Cardiac series
- Federico Raimondi, Stefano Centanni, Fabrizio Luppi, Stefano Aliberti, Francesco Blasi, Paola Rogliani, Claudio Micheletto, Marco Contoli, Alessandro Sanduzzi Zamparelli, Marialuisa Bocchino, Paolo Busatto, Luca Novelli, Simone Pappacena, Luca Malandrino, Giorgio Lorini, Greta Cairoli, Fabiano Di Marco, Respiratory rate-oxygenation index on the 3rd day is the best predictor of treatment failure in COVID-19 patients , Monaldi Archives for Chest Disease: Early Access
- The Rehabilitation Complexity Scale for respiratory patients Italian network, The ability of the Rehabilitation Complexity Scale (RCS) to capture disability in respiratory patients admitted for in-hospital rehabilitation , Monaldi Archives for Chest Disease: Early Access
- Swetabh Purohit, Manu Madan, Rohit Kumar, Rajnish Kaushik, Pranav Ish, Mahendran AJ, Shibdas Chakrabarti, Neeraj Kumar Gupta, Nitesh Gupta, Comparison of immediate withdrawal and stepwise reduction in duration of non-invasive ventilation in chronic obstructive pulmonary disease patients presenting with acute hypercapnic respiratory failure , Monaldi Archives for Chest Disease: Early Access
- Marina Pianese, Vittoria De Astis, Raffaele Griffo, Assessing patients needs in outpatients with advanced heart failure , Monaldi Archives for Chest Disease: Vol. 76 No. 2 (2011): Cardiac series
- Furio Colivicchi, David Mocini, Massimo Uguccioni, Stefano Strano, Giuseppe Imperoli, Massimo Santini, Smoking cessation interventions after Acute Coronary Syndromes. Results of a cross-sectional survey in the Lazio Region of Italy , Monaldi Archives for Chest Disease: Vol. 78 No. 2 (2012): Cardiac series
- Giorgio Berlot, Antonella Vergolini, Cristina Calderan, Rossana Bussani, Lucio Torelli, Umberto Lucangelo, Acute myocardial infarction in non-cardiac critically ill patients: a clinical-pathological study , Monaldi Archives for Chest Disease: Vol. 74 No. 4 (2010): Cardiac series
- Anna Stainer, Paola Faverio, Francesca Bono, Alberto Pesci, An unusual presentation of pulmonary lymphoma: When diffuse ground glass opacities can mean anything , Monaldi Archives for Chest Disease: Vol. 88 No. 1 (2018)
<< < 1 2 3 4 5 6 7 8 9 10 > >>
You may also start an advanced similarity search for this article.
