FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/12/029803 [Registered on: 15/12/2020] Trial Registered Prospectively
Last Modified On: 15/12/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Oxygen therapy in covid positive patients 
Scientific Title of Study   A randomised controlled trial of high flow nasal oxygen versus non rebreathing oxygen face mask therapy in acute hypoxemic respiratory failure. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhargavi Thota 
Designation  Assistant professor 
Affiliation  Sri Venkateswara Institute of Medical Sciences 
Address  Flat no 304 Sudarshan block SVIMS Quarters Sri venkateswara institute of medical sciences Tirupati
Department of Anaesthesiology Sri venkateswara institute of medical sciences Tirupati
Chittoor
ANDHRA PRADESH
517501
India 
Phone  9491579411  
Fax    
Email  bhargavi.thotambbs@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Aloka Samantaray 
Designation  Professor &HoD 
Affiliation  Sri Venkateswara Institute of Medical Sciences 
Address  Flat No.03 SVIMS old Quarters Sri venkateswara institute of medical sciences Tirupati
Department of Anaesthesiology Sri venkateswara institute of medical sciences Tirupati
Chittoor
ANDHRA PRADESH
517501
India 
Phone  9493547653  
Fax    
Email  aloksvims@gmail.com  
 
Details of Contact Person
Public Query  
Name  Aloka Samantaray 
Designation  Professor &HoD 
Affiliation  Sri Venkateswara Institute of Medical Sciences 
Address  Flat No.03 SVIMS old Quarters Sri venkateswara institute of medical sciences Tirupati
Department of Anaesthesiology Sri venkateswara institute of medical sciences Tirupati
Chittoor
ANDHRA PRADESH
517501
India 
Phone  9493547653  
Fax    
Email  aloksvims@gmail.com  
 
Source of Monetary or Material Support  
Sri venkateswara institute of medical sciences 
 
Primary Sponsor  
Name  Sri venkateswara institute of medical sciences 
Address  Sri venkateswara institute of medical sciences Tirupati 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Bhargavi thota  Sri venkateswara institiute of medical sciences Tirupati  COVID ICU (GS1, GS2), Dept of Anaesthesiology &CCM and Department of Medicine
Chittoor
ANDHRA PRADESH 		 9491579411

bhargavi.thotambbs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J128||Other viral pneumonia, (2) ICD-10 Condition: J960||Acute respiratory failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  High flow nasal oxygen cannula and non rebreathing oxygen face mask  High flow nasal oxygen delivers Fio2 100% at flow rate of 60LPM Non rebreathing oxygen face mask delivers Fio2 100% at 15 LPM. 
Intervention  High flow nasal oxygen cannula and non rebreathing oxygen face mask  High flow nasal oxygen delivers Fio2 100% at flow rate of 60LPM Non rebreathing oxygen face mask delivers Fio2 100% at 15 LPM 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  All adult patients aged 18 years and above diagnosed as acute hypoxemic respiratory failure with covid positive status 
 
ExclusionCriteria 
Details  facial abnormalities
non cardiogenic pulmonary oedema
patients who do not give consent 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
patients with treatment failure (those who need NIV support)  Any point of time during course of treatment in ICU stay. 
 
Secondary Outcome  
Outcome  TimePoints 
patient comfort
intensity of dyspnea 		 once a day will be seen 
 
Target Sample Size   Total Sample Size="122"
Sample Size from India="122" 
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   N/A 
Date of First Enrollment (India)   25/12/2020 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   All adult patients 18 years and above  with acute hypoxemic respiratory failure diagnosed as Covid 19 positive will be included in the study and standard treatment will be given as per Ministry of health and family welfare new guidelines. Once patients are not able to maintain target oxygen saturations with oxygen face mask @ 6LPM they will be given oxygen devise either High flow nasal oxygen cannula or non rebreathing oxygen face mask base on randomisation. If patients are not able to maintain saturations even with the assigned devise they will be given Non invasive mechanical ventilatory support on invasive mechanical ventilation which depends on primary treating physician and they will be considered as treatment failure.  
Close