| CTRI Number |
CTRI/2024/02/062892 [Registered on: 20/02/2024] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To ascertain the users experience with the simplicity and success of placing three supraglottic airway devices (I-gel, LMA protection, and Ambu- aura gain) |
|
Scientific Title of Study
|
A study to evaluate the ease and success
of placement of three supraglottic
airway devices(I-gel, LMA protector,
Ambu- aura gain) compared with
operator’s experience. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrPrashant kumar |
| Designation |
Professor |
| Affiliation |
Pt BD Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology & Critical Care Pt BD Sharma
PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9416336901 |
| Fax |
|
| Email |
pk.pgims@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arjun G |
| Designation |
Junior resident |
| Affiliation |
Pt BD Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology & Critical Care Pt BD Sharma
PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9688732834 |
| Fax |
|
| Email |
goodarjune@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arjun G |
| Designation |
Junior resident |
| Affiliation |
Pt BD Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology & Critical Care Pt BD Sharma
PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9688732834 |
| Fax |
|
| Email |
goodarjune@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional Pt B D Sharma PGIMS Rohtak.as PG thesis |
|
|
Primary Sponsor
|
| Name |
Pt B D Sharma University of Health and Sciences PGIMS Rohtak Haryana |
| Address |
Pt B D Sharma University of Health and Sciences PGIMS Rohtak Haryana |
| 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 Arjun G |
Pt BD Sharma PGIMS Rohtak |
Department of Anaesthesiology & Critical Care Pt BD Sharma
PGIMS Rohtak
Rohtak
HARYANA |
09688732834
goodarjune@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee BD Sharma PGIMS,Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: R198||Other specified symptoms and signsinvolving the digestive system and abdomen, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ambu aura gain |
Ambu aura Gain will be compared with iGel and LMA protector for its placement. |
| Comparator Agent |
LMA protector |
placement of LMA protector will be compared with i Gel.and ambu aura gain |
| Intervention |
Placement of iGel, will be compared with LMA Protector and ambu aura Gain during induction of anaesthesia |
1.Time taken for placement of SAD
2.Ease of placement of SAD 3.Number of attempts to place SAD
4.Operators experience with SAD placement
5.Variation in hemodynamic
6.Post procedure complications, if any |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
90 patients of either gender in the age group 18-60 yrs belonging to American Society of Anaesthesiologist (ASA) physical status I and II scheduled for elective surgery under general anaesthesia will be included in the study. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ease and success of placemnt of supraglottic devices compared with operators experience. |
Ease and success of placemnt of supraglottic devices compared with each other |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Operator experience affecting haemodynamic changes after device insertion. |
immediately after insertion, 5 minute after insertion |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
29/02/2024 |
| 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="1"
Months="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Not yet published |