CTRI Number |
CTRI/2020/07/026835 [Registered on: 27/07/2020] Trial Registered Prospectively |
Last Modified On: |
23/02/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Medical Device |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of two different types of simple non-invasive oxygen therapy devices in coronavirus lung infection |
Scientific Title of Study
|
Comparison of High Flow Nasal Oxygen and Non Invasive Ventilation in Acute Hypoxemic Respiratory Failure due to Severe COVID-19 pneumonia: A Randomized Controlled Trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dalim Kumar Baidya |
Designation |
Additional Professor |
Affiliation |
AIIMS New Delhi |
Address |
Dept of Anesthesiology, Pain Medicine and Critical Care AIIMS, New Delhi South DELHI 110029 India |
Phone |
|
Fax |
|
Email |
dalimkumar.ab8@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dalim Kumar Baidya |
Designation |
Additional Professor |
Affiliation |
AIIMS New Delhi |
Address |
Dept of Anesthesiology, Pain Medicine and Critical Care AIIMS, New Delhi South DELHI 110029 India |
Phone |
|
Fax |
|
Email |
dalimkumar.ab8@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dalim Kumar Baidya |
Designation |
Additional Professor |
Affiliation |
AIIMS New Delhi |
Address |
Dept of Anesthesiology, Pain Medicine and Critical Care AIIMS, New Delhi South DELHI 110029 India |
Phone |
|
Fax |
|
Email |
dalimkumar.ab8@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
All India Institute of Medical Sciences New Delhi |
Address |
Ansari Nagar East New Delhi India |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
Name |
Address |
All India Institute of Medical Sciences New Delhi |
Ansari Nagar East New Delhi |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dalim Kumar Baidya |
All India Institute of Medical Sciences New Delhi |
Department of Anesthesiology, Pain Medicine and Critical Care. 5th Floor, Teaching BLock, Room No 5011, AIIMS New Delhi South DELHI |
9871568534
dalimkumar.ab8@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
AIIMS Ethics Committee |
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 |
High Flow Nasal Oxygen therapy |
Patients allocated to HFNO arm will be applied HFNO through large-bore binasal prongs with a high flow heated humidifier device (Optiflow, Fisher and Paykel Healthcare). The initial gas flow rate will be 50 liters per minute and an FIO2 of 1.0. The flow and FiO2 subsequently adjusted between @ 30 – 60L/min and 0.5 -1.0 respectively to maintain SpO2 of 94% or more. |
Comparator Agent |
Non invasive ventilation |
Patients allocated to NIV arm will be applied to NIV with either mask/helmet device connected to an ICU ventilator with the setting of PS 10-20 cmH2O adjusted with the aim of obtaining an expired tidal volume of 7 to 10 ml per kilogram of predicted body weight and PEEP 5-10cmH2O titrated to target SpO2 94%. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
75.00 Year(s) |
Gender |
Both |
Details |
One hundred adult patients (aged between 18 and 75y) with laboratory confirmed diagnosis of COVID-19 pneumonia, presenting with severe COVID-19 pneumonia, who fail oxygen therapy by facemask, will be included in this study after ethics committee approval and informed written consent from the patients or their legally acceptable representatives. |
|
ExclusionCriteria |
Details |
Following patients will be excluded
i) refusal to participate,
ii) hemodynamically unstable patients on high dose vasopressor therapy
iii) pregnant patients
iv) COPD / chronic respiratory failure
v) Morbid obesity
vi) Patients with urgent requirement of invasive mechanical ventilation
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Early intubation rate - Proportion of patients requiring invasive mechanical ventilation at 48 hours of ICU admission |
Early intubation rate - Proportion of patients requiring invasive mechanical ventilation at 48 hours of ICU admission |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Early improvement in oxygenation – SpO2, RR and PaO2/FiO2 ratio in arterial blood gas at 2 hours and 24 hours
2. Late intubation rate - proportion of patients requiring invasive mechanical ventilation within day 7 of ICU admission
3. Proportion of patients requiring awake prone positioning within 48 hours
4. In-hospital mortality
|
2 hours, 24 hours, 48 hours and 7 day |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="109" |
Phase of Trial
|
Phase 3/ Phase 4 |
Date of First Enrollment (India)
|
27/07/2020 |
Date of Study Completion (India) |
31/12/2020 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Submitted for publication |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Severe COVID-19 pneumonia patients receive oxygen by facemask as primary oxygen therapy. However, patients who develop significant hypoxia may need endotracheal intubation and mechanical ventilation. Early experience shows that patients on invasive mechanical ventilation have very high mortality up to nearly 90% [5]. Therefore, use of less invasive oxygenation devices like High Flow Nasal Oxygen (HFNO) or non-invasive ventilation (NIV) may be a feasible option. In FLORALI trial performed in patients with acute hypoxemic respiratory failure, HFNO reduced 90-day mortality compared to standard oxygen therapy and facemask. Although, intubation rate was not significantly different, there was a trend towards lower intubation rate in HFNO group compared to conventional oxygen and NIV group [6]. Wang et al in their case series had described that four out of 36 critically ill patients (11%) were treated with HFNO [4]. Similarly, in another case series of 191 COVID-19 patients, 41 (21%) were treated with HFNCO (33 in ICU and 8 in non-ICU) [7]. In an observational series, among 27 patients with severe acute respiratory failure treated with HFNC or NIV, Wang et al reported intubation rate of 11.7% in HFNC patients and 11.1% in NIV patients [8]. Based on the initial experience and past data, Surviving sepsis campaign guidelines on the management of critically ill adults with COVID-19 [Ref recommend use of HFNO over NIV [9]. However, data in acute hypoxemic failure due to COVID-19 is too limited to choose between HFNC and NIV so far. We therefore plan to perform a randomized controlled trial to identify the efficacy of HFNO versus NIV in severe COVID-19 patients. |