| 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
|
|
|
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
|
|
|
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. |