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CTRI Number  CTRI/2020/07/026349 [Registered on: 03/07/2020] Trial Registered Prospectively
Last Modified On: 04/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Non-randomized, Placebo Controlled Trial 
Public Title of Study   Effect of awake proning in patients with COVID-19 related respiratory failure 
Scientific Title of Study   Effect of proning in patients with COVID-19 acute hypoxemic respiratory failure receiving non-invasive oxygen therapy: A prospective cohort study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anant Mohan 
Designation  Professor and Head 
Affiliation  AIIMS 
Address  Department of Pulmonary, Critical Care and Sleep Medicine, AIIMS, Delhi
Delhi
South
DELHI
110029
India 
Phone  9810048204  
Fax    
Email  anantmohan@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Anant Mohan 
Designation  Professor and Head 
Affiliation  AIIMS 
Address  Department of Pulmonary, Critical Care and Sleep Medicine, AIIMS, Delhi
Delhi
South
DELHI
110029
India 
Phone  9810048204  
Fax    
Email  anantmohan@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Anant Mohan 
Designation  Professor and Head 
Affiliation  AIIMS 
Address  Department of Pulmonary, Critical Care and Sleep Medicine, AIIMS, Delhi
Delhi
South
DELHI
110029
India 
Phone  9810048204  
Fax    
Email  anantmohan@yahoo.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Anant Mohan 
Address  Department of Pulmonary, Critical Care and Sleep Medicine, AIIMS, Delhi 
Type of Sponsor  Other [Professor and Head, Department of Pulmonary, Critical Care and Sleep Medicine, AIIMS, Delhi] 
 
Details of Secondary Sponsor  
Name  Address 
Anjan Trikha  Department of Anesthesiology and Pain Medicine, AIIMS, Delhi 
Karan Madan  Department of Pulmonary, Critical Care and Sleep Medicine, AIIMS, Delhi 
Pawan Tiwari  Department of Pulmonary, Critical Care and Sleep Medicine, AIIMS, Delhi 
Randeep Guleria  Department of Pulmonary, Critical Care and Sleep Medicine, AIIMS, Delhi 
Saurabh Mittal  Department of Pulmonary, Critical Care and Sleep Medicine, AIIMS, Delhi 
Sryma PB  Department of Pulmonary, Critical Care and Sleep Medicine, AIIMS, Delhi 
Vijay Hadda  Department of Pulmonary, Critical Care and Sleep Medicine, AIIMS, Delhi 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Anant Mohan  AIIMS  Department of Pulmonary, Critical Care and Sleep Medicine
South
DELHI 
01126593488

anantmohan@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committe, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, (2) ICD-10 Condition: J128||Other viral pneumonia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Prone positioning  Prone positioning for at least 30 min upto 16 hours per day till room air saturation is above 93% or till intubation 
Comparator Agent  Supine position (as usual care)  Supine position during entire ICU stay 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  a) All adults > 18 years of age with acute hypoxemic respiratory failure with room air saturation < 93% or PaO2/ FiO2 ≤300 AND
b) COVID -19 positive by RT- PCR or COVID-19 suspected as the most probable clinco-radiological diagnosis of acute respiratory failure
 
 
ExclusionCriteria 
Details  1) Age <18 yrs or >70 yrs;
2) Severe ARDS P/F < 100mmHg
3) PaCO2 >50 mm Hg;
4) Glasgow Coma Scale <11;
5) Unable to spontaneously clear secretions from the airways
6) Requirement of emergency intubation for cardiopulmonary resuscitation, respiratory arrest, severe hemodynamic instability
7) Refusal to receive NPPV/ HFNC/ NRBM
8) Unable to cooperate with NPPV/ HFNC/ NRBM application
9) Pregnancy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the rate of invasive mechanical ventilation in patients treated with awake proning along with non-invasive methods of oxygen delivery in patients of COVID -19 positive acute hypoxemic respiratory failure  till discharge or intubation  
 
Secondary Outcome  
Outcome  TimePoints 
1. To study the improvement in oxygenation parameters (SO2, SO2/ FiO2, PaO2/ FiO2 ratio and ROX index) in patients undergoing prone positioning
2. Duration of hospital stay
 
till discharge or intubation 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   04/07/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Coronavirus disease 2019 (COVID-19) is an emerging infectious disease that was first reported in Wuhan, Hubei Province China, and has subsequently spread worldwide in more than 200 countries including India. Although majority of patients have a favourable prognosis, the older age group, and presence of chronic diseases have been reported to have worse outcomes. Severe illness is marked by development of dyspnea, hypoxemia and progression to acute respiratory distress syndrome (ARDS) within one week of onset of symptoms (1). The most documented reason for requiring intensive care has been respiratory support, of which two-thirds of patients have met criteria for acute respiratory distress syndrome. Care of critically ill patients of COVID 19 is resource intensive, especially important in developing nations like India. Use of non-invasive methods of oxygen deliverywith high flow nasal cannula(2) and non-invasive ventilation(3,4) is an option in mild to moderate ARDS and may reduce the need for invasive mechanical ventilation. Any intervention which may result in reducing the need for intubation and mechanical ventilation can have a major impact in resource conservation in a pandemic situation.The aim of our study is to determine whether the early use of prone positioning (PP) combined with oxygen by non-rebreather mask (NRBM), non-invasive ventilation (NIV) or high-flow nasal cannula (HFNC) can avoid the need for intubation mild to moderate ARDS.

 
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