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CTRI Number  CTRI/2025/11/096767 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 02/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   The effect of I-gel vs endotracheal tube on atelactasis in pediatric patients undergoing general anesthesia assessed by lung ultrasound 
Scientific Title of Study   The effect of I-gel versus endotracheal tube on atelactasis in paediatric patients undergoing general anesthesia assessed by lung ultrasound: A prospective randomised study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Alok jha 
Designation  Postgraduate resident 
Affiliation  IGIMS;sheikhpura,patna 
Address  Department of Anesthesia and critical care medicine,IGIMS,sheikhpura,Patna

Patna
BIHAR
800014
India 
Phone  9262367744  
Fax    
Email  alok.jha300898@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vinod Kumar verma 
Designation  Professor 
Affiliation  IGIMS,sheikhpura,Patna 
Address  Department of ANESTHESIA and Critical care medicine

Patna
BIHAR
800014
India 
Phone  8292000111  
Fax    
Email  drvvinodv@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vinod Kumar verma 
Designation  Professor 
Affiliation  IGIMS,sheikhpura,Patna 
Address  Department of ANESTHESIA and Critical care medicine

Patna
BIHAR
800014
India 
Phone  8292000111  
Fax    
Email  drvvinodv@gmail.com  
 
Source of Monetary or Material Support  
Indira Gandhi institute of medical sciences,Patna,Bihar,800014 
 
Primary Sponsor  
Name  Indira Gandhi institute of Medical sciences Patna 
Address  Department of Anesthesiology Neuro OT complex Indira Gandhi institute of medical sciences Patna 
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 Alok jha Department of Anesthesiology   Indira Gandhi institute of medical sciences, Patna, Bihar  Indira Gandhi institute of medical sciences,Patna,800014,Bihar
Patna
BIHAR 
9262367744

alok.jha300898@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee,Indira Gandhi institute of medical sciences,PATNA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Endotracheal tube  Endotracheal tube causes atelactasis. We are assessing this in pediatric patient. 
Intervention  I gel airway   Assessing effect of Igel airway on atelactasis in pediatric patient. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  ASA 1-3,elective surgery of duration more than 1 hour in supine position,informed consent from parents/guardians 
 
ExclusionCriteria 
Details  Chest deformities,thoracic surgery history,recent respiratory tract infection,airway abnormality,high aspiration risk 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Incidence and severity of lung atelactasis assessed by lung ultrasound  15 minutes after airway insertion 
 
Secondary Outcome  
Outcome  TimePoints 
Lung atelactasis  at extubation and 30 minutes after extubation 
Incidence of postoperative airway complication   at 24 hour and 48 hour post-operation 
Incidence of postoperative pulmonary complications   Within 48 hour 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 3/ Phase 4 
Date of First Enrollment (India)   18/11/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Atelectasis (collapse of part of the lung) is a common complication during and after general anaesthesia in children. It can reduce oxygenation, cause breathing problems, and increase the risk of postoperative complications. Different airway devices used during anaesthesia may influence the risk of atelectasis.


The i-gel is a supraglottic airway device that is easy to insert, causes less irritation, and maintains airway patency during anaesthesia. The endotracheal tube (ETT) is the conventional method for airway management but requires more manipulation, may cause airway irritation, and can be associated with a higher risk of atelectasis.


This study is a randomized clinical trial comparing i-gel and ETT in children aged 1–14 years undergoing elective surgeries lasting more than one hour. One hundred children will be enrolled and randomly assigned to either i-gel or ETT groups. Lung ultrasound, a safe and radiation-free bedside tool, will be used to assess atelectasis at different time points during and after surgery.


The primary outcome is the degree of atelectasis 15 minutes after airway insertion. Secondary outcomes include atelectasis at extubation and 30 minutes after extubation, airway complications (such as sore throat and hoarseness), postoperative pulmonary complications, and hospital stay.


The results of this study will help determine whether i-gel or ETT is better in reducing lung atelectasis and improving recovery in children undergoing anaesthesia.

 
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