| CTRI Number |
CTRI/2024/04/065115 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to compare two different techniques of i gel insertion i.e simple and rotational technique in adult patients undergoing elective surgeries |
|
Scientific Title of Study
|
Comparative study of techniques of i gel insertion via simple and rotational techniques in adult patients posted for elective surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Inayat garg |
| Designation |
Assistant professor |
| Affiliation |
Adesh institute of medical sciences and research |
| Address |
Department of Anesthesiology and Intensive care,2floor Ot Complex ,Adesh Institute of Medical Sciences and Research
Bathinda
PUNJAB
151001
India |
| Phone |
7508683611 |
| Fax |
|
| Email |
inayatgarg93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Inayat garg |
| Designation |
Assistant professor |
| Affiliation |
Adesh institute of medical sciences and research |
| Address |
Department of Anesthesiology and Intensive care,2 floor Ot Complex,Adesh Institute of Medical Sciences and Research
Bathinda
PUNJAB
151001
India |
| Phone |
7508683611 |
| Fax |
|
| Email |
inayatgarg93@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nitika |
| Designation |
Junior resident |
| Affiliation |
Adesh institute of medical sciences and reseach |
| Address |
Department of Anesthesiology and Intensive care,Ot Complex,Adesh Institute of Medical Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
9872076760 |
| Fax |
|
| Email |
nitika06sgrd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Adesh institute of medical sciences and research |
|
|
Primary Sponsor
|
| Name |
Inayat garg |
| Address |
Aman hospital near new bus stand
gt road |
| Type of Sponsor |
Other [Individual (no sponsor required)] |
|
|
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 |
| Inayat garg |
Adesh institute of mrdical sciences and research |
Aman hospital near new bus stand gt road
Bathinda
PUNJAB |
7508683611
inayatgarg93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee(EC),Adesh University,Bathinda |
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 |
| Intervention |
Comparison of I gel insertion technique |
I gel inserted by rotational technique |
| Intervention |
Comparison of I gel insertion technique |
I gel inserted by standard technique |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2
Age 21-50 years
Body mass index(BMI) 18-25kg/m2 |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| insertion time |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| insertion time |
13 seconds |
|
|
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)
|
10/04/2024 |
| 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="0"
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
|
This study is a randomized controlled single blind study comparing the techniques of I gel insertion via simple and rotational technique in adult patients undergoing elective surgeries. The aim of this study is to observe the ease of i gel insertion by comparing two techniques. The primary objective of this study is to compare the mean time of insertion, number of attempts and complications like gastric inflation and aspiration via these techniques. |