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CTRI Number  CTRI/2024/08/071807 [Registered on: 01/08/2024] Trial Registered Prospectively
Last Modified On: 09/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the efficiency of the NEW device HFNC used as a method of oxygenation with traditional oxegenation devices like FACE MASK etc in preventing the respiratory failure after extubation of a patient.  
Scientific Title of Study   Effect of High Flow Nasal Oxygenation versus conventional oxygen therapy in preventing reintubation after planned extubation in ICU patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rasha Saleem 
Designation  Junior Resident - Emergency Medicine 
Affiliation  Aiims Patna 
Address  Room number 215, Hostel 11, Emergency medicine CGB, All India Institute Of Medical Sceince Patna, Phulwari sheriff (P.O)

Patna
BIHAR
801507
India 
Phone  7025380250  
Fax    
Email  rasha11950@aiimspatna.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepak kumar  
Designation  Assistant Professor- Emergency Medicine 
Affiliation  Aiims Patna 
Address  CGB, Emergency Medicine, All India Institute Of Medical Sceince Patna, Phulwari sheriff (P.O)

Patna
BIHAR
801507
India 
Phone  9717864257  
Fax    
Email  dr.deepak11706@aiimspatna.org  
 
Details of Contact Person
Public Query  
Name  Rasha Saleem 
Designation  Junior Resident - Emergency Medicine 
Affiliation  Aiims Patna 
Address  Room number 215, Hoatel 11 CGB-Emergency medicine All India Institute Of Medical Sceince Patna, Phulwari sheriff(P.O)

Patna
BIHAR
801507
India 
Phone  7025380250  
Fax    
Email  rasha11950@aiimspatna.org  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sceinces Patna Phulwari sheriff (P.O), Patna, Bihar, 801507 
 
Primary Sponsor  
Name  AIIMS PATNA 
Address  AIIMS PATNA, Phulwari sheriff (P.O), Patna, Bihar 801507  
Type of Sponsor  Government medical college 
 
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 
Dr Rasha Saleem  Aiims Patna   T11 ICU, 4th floor, trauma block, AIIMS PATNA, Phulwari sheriff(P.O), Patna, Bihar, 801507
Patna
BIHAR 		 7025380250

rasha11950@aiimspatna.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Aiims Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: X||New Technology,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional oxygen therapy group  Patient after extubation are usually put on conventional oxygen therapy like NRM, face mask, nasal canula and in this study we are use NRM as the comparison group. The patient is kept on NRM for 24 hours and respiratory, ABG parameter taken at 1st,6th,12th,24th and 48th hrs and is looked for any signs of respioratory failures and need there by need for re intubation. 
Intervention  HFNO group   Patients who are being extubated are kept on HFNO to compare the rate of reintubation with conventional oxygen therapy. The patient is kept on HFNO for 24 hours and respiratory, ABG parameter taken at 1st,6th,12th,24th and 48th hrs and is looked for any signs of respioratory failures and need there by need for re intubation.  
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Age more than 18 years and less than 75 years
BMI less than 30 kg/m2
Minimum 12 hours and maximum 7days of intubation period  
 
ExclusionCriteria 
Details 
Tracheostomised patients
Pregnant patient
Patients with congestive heart disease
Re intubated patients  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine the efficacy of High Flow Nasal Oxygenation in preventing reintubation within 48 hours of planned extubation by comparing the 1st, 6th, 12th, 24th, 48th hours ABG parameters and respiratory parameters with the NRM which may indcicate the need for re intubation.  At 1st, 6th, 12th, 24th, 48th hours ABG parameters and respiratory parameters are recorded to look for any respiratory failure and rates of re intubation in  
 
Secondary Outcome  
Outcome  TimePoints 
The respiartory failure within 48 hours of extubation measures via ABG & Respiratory parameters  1st, 6th, 12th, 24th, 48th hours ABG parameters & respiratory parameters are measures to assess for respiratory failure. 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
Final Enrollment numbers achieved (Total)= "102"
Final Enrollment numbers achieved (India)="102" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   15/09/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/12/2025 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Not yet published  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 After extubation we are currently using conventional oxygen delivery devices like NRM  and sometimes other devices like nasal canula, face mask, venturi mas. When compared with other conventional oxygen delivery devicesafter extubation, high flow nasal oxygen provides physiological advantages since it can provide 100% FiO2 and 60L/min flow. Current data, mainly observational, show that HFNO could be used particularly for the management of hypoxemic ARF, notably in the more severe form. HFNO appears to be effective in patients experiencing high risk of respiratory failure after extubation compared with low-flow oxygen. As of yet, very few high-quality studies have been published evaluating these indications, so recommendations regarding clinical applications of HFNC remain tentative. This study is done to determine the efficacy  of High Flow Nasal Oxygenation in preventing reintubation within 48 hours of planned extubation. 
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