| CTRI Number |
CTRI/2025/02/081026 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of two techniques of inserting a airway device in pediatric age group |
|
Scientific Title of Study
|
Device Profile Of i-gel: Comparison of two insertion techniques |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHIVANI RATHOD |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
K S HEGDE MEDICAL ACADEMY |
| Address |
Department of Anaesthesiology and Critical care, K S Hegde Medical Academy, P.O Nithyanandagar, Mangalore, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7019268541 |
| Fax |
|
| Email |
shivanirathod1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUMALATHA SHETTY |
| Designation |
PROFESSOR |
| Affiliation |
K S HEGDE MEDICAL ACADEMY |
| Address |
Department of Anaesthesiology and Critical care, K S Hegde Medical Academy, P.O Nithyanandagar, Mangalore, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9448115617 |
| Fax |
|
| Email |
sumarshetty@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
SHIVANI RATHOD |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
K SHEGDE MEDICAL ACADEMY |
| Address |
Department of Anaesthesiology and Critical care, K S Hegde Medical Academy, P.O Nithyanandagar, Mangalore, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7019268541 |
| Fax |
|
| Email |
shivanirathod1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| K S Hegde Medical Academy Deralakatte Mangaluru
Karnataka - 575018 |
|
|
Primary Sponsor
|
| Name |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesiology and Critical care, K S Hegde Medical Academy, P.O Nithyanandagar, Mangalore, Karnataka - 575018 |
| Type of Sponsor |
Private 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 SHIVANI RATHOD |
K S HEGDE MEDICAL HOSPITAL |
Department of Anaesthesiology and Critical care, K S Hegde Medical Academy, P.O Nithyanandagar, Mangalore, Karnataka
Dakshina Kannada
KARNATAKA |
7019268541
shivanirathod1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, K S HEGDE MEDICAL ACADEMY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective surgeries under general anaesthesia
1.Age of 6 Months-18 Years
2.ASA 1 and 2 |
|
| ExclusionCriteria |
| Details |
1.Refusal to enrol in the study by Parent/Guardian and patient(ASSENT WHERE INDICATED)
2.Patients with Upper Respiratory tract infections
3.Children risk of regurgitation
4.Patients with obvious Airway Pathology |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison of device profile of i-gel with 2 techniques of insertion in terms of
1.Proper placement of i-gel using Fiberoptic view
2.First attempt success rate
3.Time for insertion
4.Airway seal pressure measured using the peak airway pressure at minimal leak |
After induction of general anaesthesia
1.Attempts and ease of insertion of i-gel
2.After insertion of i-gel for proper placement and oropharyngeal air leak pressure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of complication in terms of
1.Additional maneuvers required
2.Emergence cough
3.Airway trauma |
1.While insertion of i-gel
2.At end of procedure, After extubation of i-gel |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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 1 |
|
Date of First Enrollment (India)
|
18/03/2025 |
| 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="0"
Months="8"
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
|
Two insertion techniques for I-gel in paediatric patients undergoing general anesthesia aims to evaluate two methods standard insertion or reverse insertion with jaw thrust provides better placement success, shorter insertion time, and improved airway seal pressure. |