| CTRI Number |
CTRI/2023/09/057684 [Registered on: 15/09/2023] Trial Registered Prospectively |
| Last Modified On: |
14/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative study to assess the safety and efficacy of Ambu Aura Gain versus I-Gel ( supraglottic airway devices) in adult patients under General Anaesthesia |
|
Scientific Title of Study
|
A prospective randomized comparative study to assess the safety and efficacy of Ambu Aura Gain versus I-Gel in adult patients under General Anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr CHAITHANYASHREE R |
| Designation |
Junior Resident |
| Affiliation |
Mysore Medical College and research institute. |
| Address |
Mysore Medical college and Research Institute, Irwin Road, Mysore.
Mysore
KARNATAKA
570001
India |
| Phone |
8147978472 |
| Fax |
|
| Email |
chaithanyashreer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayalakshmi B C |
| Designation |
Professor |
| Affiliation |
Mysore Medical College and Research Institute. |
| Address |
Mysore Medical College and Research Institute, Irwin Road, Mysore.
Mysore
KARNATAKA
570001
India |
| Phone |
9886239622 |
| Fax |
|
| Email |
vijayanagaraj@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chaithanyashree R |
| Designation |
Junior Resident |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
Mysore Medical college and Research Institute, Irwin Road, Mysore.
Mysore
KARNATAKA
570001
India |
| Phone |
8147978472 |
| Fax |
|
| Email |
chaithanyashreer@gmail.com |
|
|
Source of Monetary or Material Support
|
| KR Hospital, Irwin Road, Devaraja Mohalla, Mysore-570001. |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia MMCRI Mysore |
| Address |
K R Hospital,Mysore Medical College, Irwin Road , Mysore-570001. |
| 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 Chaithanyashree R |
Krishnarajendra Hospital |
Department of Anaesthesia, MMCRI, KR Hospital,Irwin Road, Devaraja Mohalla, Yadavagiri.
Mysore
KARNATAKA |
8147978472
chaithanyashreer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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 |
Group A |
Insertion Of Ambu Aura Gain in adult patients undergoing elective surgeries under general anaesthesia. |
| Intervention |
Group I |
Insertion of I gel supraglottic device in adult patients undergoing elective surgeries under general anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
All ASA grade I and II patients between 18-50 years of both sex.
Elective surgeries under general anaesthesia with controlled ventilation.
Body mass index 25-28 Kg/m2.
Duration of surgery <2hrs. |
|
| ExclusionCriteria |
| Details |
Age <18 years and > 50 years.
All ASA grade III and above.
Mallampatti grade 3 and above.
Emergency surgeries.
Head and neck surgeries.
Patients with decreaesed mouth opening.
Patients with increased risk of aspiration.
Patients with BMI >28 Kg/m2.
Patients with abnormal or distorted anatomy of pharynx. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Oropharyngeal leak pressure
Ease of Insertion & number of attempts.
Time taken for insertion.
Ease of insertion of Ryles tube .
Fibreoptic bronchoscopic grading. |
10 min
2 min
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Haemodynamic response, SpO2, EtCO2
Incidence of post operative complications |
2 hrs
24hrs. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
24/09/2023 |
| 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="0"
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
|
This study is a prospective randomised comparative study to assess the safety and efficacy of Ambu Aura gain versus I-gel in adult patients under general anaesthesia in eleective surgeries in KR hospital, Mysore, India. |