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CTRI Number  CTRI/2025/01/079639 [Registered on: 28/01/2025] Trial Registered Prospectively
Last Modified On: 18/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing effect of Pre oxygenation using high flow nasal oxygen and oxygen mask during rapid sequence intubation 
Scientific Title of Study   To Compare the effect of Pre oxygenation using high flow nasal oxygen and tight face mask technique during rapid sequence induction in Abdominal Surgeries 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dara Lakshmi Harshitha 
Designation  MD Aanaesthesia 
Affiliation  Jawaharlal Nehru Institute of Medical Sciences  
Address  Jawaharlal Nehru Medical College Sawangi (Meghe), Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9398889033  
Fax    
Email  harshithadara212@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vivek Chakole 
Designation  Professor Of Anaesthesia 
Affiliation  Jawaharlal Nehru institute of medical sciences 
Address  Jawaharlal Nehru Medical College Sawangi (Meghe), Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  7583836564  
Fax    
Email  hod.anesthesiajnmc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dara Lakshmi Harshitha 
Designation  MD Anaesthesia 
Affiliation  Jawaharlal Nehru Institute of Medical Sciences  
Address  Jawaharlal Nehru Medical College Sawangi (Meghe), Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9398889033  
Fax    
Email  harshithadara212@gmail.com  
 
Source of Monetary or Material Support  
Acharya Vinobha Bhave Rural Hospital , Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe) Wardha. 442001, Maharashtra India. 
 
Primary Sponsor  
Name  Datta Meghe Insititute of Higher Education and Research 
Address  Jawaharlal Nehru Medical College Sawangi (Meghe), Wardha,Maharashtra ,India,442107 
Type of Sponsor  Private 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 
DrDara Lakshmi Harshitha   Acharya Vinoba Bhave Rural Hospital  Department of Anaesthesia
Wardha
MAHARASHTRA 		 9398889033

harshithadara212@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE DATTA MEGHE INSTITUTE OF HEALTH SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comparing preoxygenation using high flow nasal oxygen during rapid sequence intubation   High flow nasal oxygen used to increase the apnoea time and to avoid desaturation during rapid sequence intubation  
Comparator Agent  Comparing Preoxygenation using tight face mask during rapid sequence induction  Tight face mask technique has high chances of desaturation during Rapid Sequence Induction in abdominal surgeries 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients willing to participate in study
2.Weight between 40-70kgs
3.ASA Physical status I and II
4.Patients undergoing abdominal surgeries under general anesthesia 
 
ExclusionCriteria 
Details  1.Patients not willing to participate in study
2.Patients not reaching oxygen saturations greater than 93%
3.BMI greater than 35kgs
4.Pregnangy
5.Need for non invasive ventilation before anesthesia 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Number of patients who develop oxygen saturations less than 93% on a peripheral pulse oximeter on using tight face mask and high flow nasal cannula from the time of preoxygenation until one minute after intubation  To compare the oxygen saturations of high flow nasal oxygen with tight face mask  
 
Secondary Outcome  
Outcome  TimePoints 
1.To measure ETCO2 within one minute after tracheal intubation
2. To assess the hemodynamic response of the patients 		 The present innovation helps to minimize the time of performing task as compared to conventional method 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 2 
Date of First Enrollment (India)   12/02/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [harshithadara997@gmail.com].

  6. For how long will this data be available start date provided 23-10-2024 and end date provided 23-09-2024?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Pre-oxygenation using high-flow nasal oxygen can decrease the risk of desaturation during rapid sequence induction in abdominal surgeries.This study is to prolong the apnoea time where intermittent positive pressure ventilation is avoided to tracheal intubation. 
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