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CTRI Number  CTRI/2024/09/073311 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 04/09/2024
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   Effect of bundle of interventions on atelectasis in elderly undergoing general anesthesia 
Scientific Title of Study   Comparison of a bundle of interventions with existing practices to reduce anesthesia induced atelectasis in elderly undergoing general anesthesia for non-cardiac surgeries – A double blind, randomized controlled 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 Avinash R Naik  
Designation  Junior Resident  
Affiliation  AIIMS Bhubaneswar 
Address  Department of Anaesthesiology and Critical Care, AIIMS Bhubaneswar.

Khordha
ORISSA
751019
India 
Phone  9738102507  
Fax    
Email  avinashnaik0502@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr P Bhaskar Rao  
Designation  Professor  
Affiliation  AIIMS Bhubaneswar 
Address  Department of Anaesthesiology and Critical Care, AIIMS Bhubaneswar.

Khordha
ORISSA
751019
India 
Phone  8926251076  
Fax    
Email  anaes_bhaskar@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Avinash R Naik 
Designation  Junior Resident  
Affiliation  AIIMS Bhubaneswar 
Address  Department of Anaesthesiology and Critical Care, AIIMS Bhubaneswar.

Khordha
ORISSA
751019
India 
Phone  9738102507  
Fax    
Email  avinashnaik0502@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences Bhubaneswar, Sijua, Patrapada, Khordha, Orissa, PIN 751019, India 
 
Primary Sponsor  
Name  AIIMS Bhubaneswar 
Address  Sijua, Patrapada, Bhubaneswar, Khordha, Odisha, 751019 
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 
Dr Avinash R Naik   All India Institute of Medical Sciences Bhubaneswar   Department of Anaesthesiology and Critical Care, Room number 154, 1st floor, Sijua, Patrapada, Bhubaneswar, Khordha, Orissa, PIN 751019, India
Khordha
ORISSA 		 9738102507

avinashnaik0502@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of Medical Sciences Bhubaneswar   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  Bundle Group  Preoxygenation in a 25degree head-up position with an FiO2 of 50% on volume controlled ventilation with a tidal volume of 8 ml/kg and a PEEP of 5 cm H2O. Then patients will be induced with institutional standard practice of premedication. During the intraoperative period, FiO2 kept as low as possible to maintain a SpO2 more than or equal to 95%. Additionally, hourly recruitment manoeuvres will be performed (PEEP of 30 cmH2O for 30 seconds). For reversal, Sugammadex will be administered at a dosage of 2 mg/kg.  
Comparator Agent  Existing Practice Group   Preoxygenation in supine position with variable FiO2 on manual mode ventilation. Then patient will be induced with institutional standard practice of premedication. During intraoperative period, FiO2 kept at 50% without recruitment manoeuvres. For reversal, Neostigmine at a dosage of 0.05 mg/kg + Glycopyrrolate at a dosage of 0.1 mg/kg will be administered.  
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients posted to surgeries under general anesthesia with duration of surgeries more than or equal to 2 hours belonging to ASA I - III including elective and emergency operations, as well as both laparoscopic and open surgical techniques. 
 
ExclusionCriteria 
Details  Patient refusal to give consent, patients with BMI more than or equal to 30 kg/m2, with pre-existing lung disease / chest trauma, patients posted for cardiothoracic/lung surgeries, patient not getting extubated within 24 hours of surgery in ICU, Pregnant woman, patients with progressive neuromuscular weakness, chronically bed-ridden, patients posted for redo surgeries.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the incidence of anesthesia induced atelectasis in both groups after surgery using
lung aeration score of score more than or equal to 2 by lung ultrasonography 		 Before induction of anesthesia and after 1 hour of surgery and within 24 hours if patient shifted to ICU intubated 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the incidence of anesthesia induced atelectasis in Laparoscopic & Open
surgeries 		 Before induction of anesthesia and after 1 hour of surgery and within 24 hours if patient shifted to ICU intubated 
To compare the incidence of postoperative pulmonary complications  Seven days postoperatively or till the day of discharge  
To compare the effect of predefined causes for anesthesia induced atelectasis such as
age, PEEP, position of surgery, etc. 		 Intraoperative  
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
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 4 
Date of First Enrollment (India)   15/09/2024 
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="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 - NO
Brief Summary  

The incidence of anesthesia induced atelectasis was found to be 90% in patients undergoing general anesthesia. And anesthesia induced atelectasis accounts for nearly 30% for the development of postoperative pulmonary complications which have a major impact on the mortality and morbidity of patients undergoing major surgery. There have been studies for techniques to reduce the incidence of anesthesia induced atelectasis in isolation. So, we hypothesise that these interventions when combined together (bundle) will be more effective than existing institutional practices in reducing anesthesia induced atelectasis.

 
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