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
Abstract Views: 1318
PDF: 334
Supplementary: 100
Supplementary 2_Ethics-Trial: 80
Supplementary 3-CONSORT Checklist: 118
Supplementary 4-Ministry of Health and Family Welfare handout: 85
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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

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*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

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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.in

How 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.