| 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
|
|
|
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
|
|
|
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. |