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CTRI Number  CTRI/2021/09/036699 [Registered on: 21/09/2021] Trial Registered Prospectively
Last Modified On: 15/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The effect of two different intraoperative inspired oxygen concentration on postoperative respiratory complications in patients above 60yrs of age undergoing elective surgery under general anesthesia: a randomized-controlled trial 
Scientific Title of Study   The effect of two different intraoperative inspired oxygen concentration on postoperative pulmonary atelectasis in Geriatric patients undergoing elective surgery under general anesthesia: 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  Pradeep Kumar Bhatia 
Designation  Additional Professor and Head Of Department  
Affiliation  AIIMS Jodhpur 
Address  Department of Anesthesiology and Critical care, AIIMS Jodhpur.

Jodhpur
RAJASTHAN
342005
India 
Phone  9829159665  
Fax    
Email  pk_bhatia@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Pradeep Kumar Bhatia 
Designation  Additional Professor and Head Of Department  
Affiliation  AIIMS Jodhpur 
Address  Department of Anesthesiology and Critical care, AIIMS Jodhpur.

Jodhpur
RAJASTHAN
342005
India 
Phone  9829159665  
Fax    
Email  pk_bhatia@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Pradeep Kumar Bhatia 
Designation  Additional Professor and Head Of Department  
Affiliation  AIIMS Jodhpur 
Address  Department of Anesthesiology and Critical care, AIIMS Jodhpur.

Jodhpur
RAJASTHAN
342005
India 
Phone  9829159665  
Fax    
Email  pk_bhatia@yahoo.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Jodhpur 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences AIIMS Jodhpur 
Address  All India Institute of Medical Sciences AIIMS Jodhpur, Basni Industrial Area, MIA phase 2nd, Basni, 342005 
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 Chitra   All India Institute Of Medical Sciences,Jodhpur  Anaesthesiology And Critical Care Medicine,Operation Theatre
Jodhpur
RAJASTHAN 		 9557782699

chitrasaun2696@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: PCS||, (2) ICD-10 Condition: K638||Other specified diseases of intestine,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  High Fraction of inspired oxygen  Receive inspired 80% oxygen mixed with air 
Intervention  Low fraction of inspired oxygen   Receive inspired 30% oxygen mixed with air 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients aged more than 60 years and scheduled for elective major surgery of duration more than 2 hours under general anaesthesia will be enrolled. 
 
ExclusionCriteria 
Details  1. Patient undergoing cardio-thoracic surgery, thoracotomies
2. Patients with active upper or lower airway infection
3. Patients with abnormal preoperative chest X‐ray findings
4. Patients who are likely to require postoperative mechanical ventilation
5. Morbidly obese patients (BMI-35Kg/m2)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the incidence and severity of postoperative atelectasis determined by CT thorax.  To compare the incidence and severity of postoperative atelectasis during postoperative period upto 24hrs determined by CT thorax. 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare postoperative gas exchange by PaO2/FIO2.   before preoxygenation and postoperatively at 1-hour, 6-hours and 12-hours 
2.To compare incidence of postoperative nausea and vomiting.   24 hours postoperatively. 
3.To compare incidence of surgical site infection.  Till 5 days postoperatively. 
4.To compare requirement of postoperative respiratory support (oxygen supplementation/ mechanical ventilation).  Till day 3 postoperatively. 
5.To compare incidence of postoperative pneumonia.  Till day 3 postoperatively. 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "47"
Final Enrollment numbers achieved (India)="47" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2021 
Date of Study Completion (India) 12/11/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 12/11/2022 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

All patients requiring general anaesthesia need oxygen administration. Supplementing patients with high inspired oxygen is considered to have harmful effects on lung physiology and increases the chances of postoperative pulmonary complications. But recent studies suggest that there is no clinically significant difference in postoperative lung atelectasis between low and high intraoperative inspired oxygen. However, high inspired oxygen is beneficial in reducing incidence of  postoperative vomiting and  surgical site infection. Most of the studies have been conducted in healthy individual to our best knowledge.


So,we planned to do a randomised study on the effect of two different intraoperative inspired oxygen concentrations on postoperative pulmonary atelectasis in geriatric patients undergoing elective surgeries .

 
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