| CTRI Number |
CTRI/2025/09/094669 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the pinna size based technique with the weight based technique for selecting appropriate size Igel in paediatric patients(6 months to 12 years) planned for surgery under general anaesthesia |
|
Scientific Title of Study
|
COMPARISON OF PINNA SIZE BASED AND WEIGHT BASED TECHNIQUE FOR I-GEL SIZE SELECTION IN PAEDIATRIC PATIENTS PLANNED FOR SURGERY UNDER GENERAL ANAESTHESIA |
| 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 Raveena |
| Designation |
PG resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care,Vardhman Mahavir Medical College and Safdarjung hospital,Ansari Nagar East,New Delhi
New Delhi
DELHI
110029
India |
| Phone |
7419260465 |
| Fax |
|
| Email |
drraveena5808@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amandeep Jaswal |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir Medical college and Safdarjung hospital,Ansari nagar East,New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9582142904 |
| Fax |
|
| Email |
amandeep.jaswal05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amandeep Jaswal |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir Medical college and Safdarjung hospital,Ansari nagar East,New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9582142904 |
| Fax |
|
| Email |
amandeepjaswal05@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung hopital |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Ansari Nagar East,New Delhi |
| 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 Raveena |
VMMC and Safdarjung Hospital |
Department of Anaesthesia and Intensive care,Ansari nagar East,Delhi 110029
New Delhi
DELHI |
74192 60465
drraveena5808@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VMMC AND SAFDARJUNG HOSPITAL INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z418||Encounter for other procedures forpurposes other than remedying health state, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Igel size selection |
Igel size selection based on pinna size and weight in paediatric patients planned for surgery under general anaesthesia |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 patients posted for surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1.Congenital ear anomalies
2.Recent history of respiratory tract infection
3.Any gross facial anomaly like trauma,burns,restricted mouth opening
4.Upper airway obstruction
5.Patients Who require endotracheal tube intubation/RSI |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the pinna size based and weight based techniques for Igel size selection by Oropharyngeal seal pressure in paediatric patients planned for surgery under general anaesthesia |
Intraoperatively after Igel insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare ease of inserion,number of attempts for successful insertion of Igel and audible leak |
Intraoperatively during Igel insertion |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
22/09/2025 |
| 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="1"
Months="6"
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
|
Two groups will be formed , one based on pinna size of the patient and the other based on weight of the patient and then appropriate size of Igel will be selected based on these and oropharyngeal seal pressure will be measured. |