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CTRI Number  CTRI/2024/11/076427 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 28/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effects of giving oxygen by two different methods before surgery 
Scientific Title of Study   Evaluation of two different methods of preoxygenation in surgical patients – a parallel group randomised trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhilasha Motghare 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Rajkot Gujarat 
Address  Department of Anesthesiology and Perioperative Care All India Institute of Medical Sciences Rajkot Gujarat

Rajkot
GUJARAT
360110
India 
Phone  9860819602  
Fax    
Email  pacaiimsrajkot@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhilasha Motghare 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Rajkot Gujarat 
Address  Department of Anesthesiology and Perioperative Care All India Institute of Medical Sciences Rajkot Gujarat

Rajkot
GUJARAT
360110
India 
Phone  9860819602  
Fax    
Email  pacaiimsrajkot@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhilasha Motghare 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Rajkot Gujarat 
Address  Department of Anesthesiology and Perioperative Care All India Institute of Medical Sciences Rajkot Gujarat

Rajkot
GUJARAT
360110
India 
Phone  9860819602  
Fax    
Email  pacaiimsrajkot@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Rajkot Gujarat  
 
Primary Sponsor  
Name  Anesthesia Department 
Address  All India Institute of Medical Sciences Rajkot Khanderi Paddhari Gujarat 360110 
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 Abhilasha Motghare  All India Institute of Medical Sciences Rajkot Gujarat   Department of Anesthesiology and Perioperative Care
Rajkot
GUJARAT 		 9860819602

pacaiimsrajkot@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   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 
Comparator Agent  Preoxygenation using Four Vital Capacity Breathing  This group of Participants will be preoxygenated with four vital capacity breathing technique with 100 % oxygen for 30 secs before induction of general anesthesia These group of participants will be given 100% oxygen while the participants are taking four deep vital capacity breaths  
Intervention  Preoxygenation using Tidal Volume Breathing   Before induction of general aesthesia the participants will be preoxygenated using 100 % oxygen for 3 minutes These group of participants will be given 100% oxygen for 3 minutes while participants are breathing normally with tidal volume breaths 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA I/II Participants who are posted for surgery under general anesthesia  
 
ExclusionCriteria 
Details  difficult airway, obese (BMI more than 30), pregnancy, respiratory disorders or diseases, regurgitation disorders (risk of aspiration), difficult mask ventilation (edentulous, beard, sunken cheeks); poor comprehension to understand deep breathing technique h/o lung pathology like pleural effusion / consolidation or abnormal CXR findings  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To note the FetO2 ( Fraction of end tidal oxygen concentration ) at the end of preoxygenation   at the end of preoxygenation
i.e 3 minutes in tidal volume breathing and 30 secs in vital capacity breathing 
 
Secondary Outcome  
Outcome  TimePoints 
Frequency of episodes of desaturation during intubation   during the procedure of endotracheal intubation (all the episodes of desaturation SPO2 less than 90% will be noted all thetime during the intubation) 
LUSS ( Lung Ultrasound Score )   LUSS 1- Basal
LUSS 2- After Preoxgeantion
LUSS 3- After Extubation/ Recovery Room  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   10/11/2024 
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="10"
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 - NO
Brief Summary   The Trial intends to evaluate the effects of preoxygenation by two different methods. We want to know the FetO2 achieved the end of preoxygenation by these two methods. We would also like to evaluate whether the method of preoxygenation has any contribution to the development of basal lung atelectasis which is commonly seen in patient undergoing surgery with general anesthesia.  
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