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CTRI Number  CTRI/2020/07/026835 [Registered on: 27/07/2020] Trial Registered Prospectively
Last Modified On: 27/07/2020
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  
AIIMS New Delhi 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere, 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)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   27/07/2020 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Brief Summary  

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.  
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