| CTRI Number |
CTRI/2024/08/072520 [Registered on: 14/08/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Other (Specify) [COMPARATIVE] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two supraglottic airway devices that are placed over pharynx (i-gel versus ambu auragain) in adult patient undergoing various surgeries under general anesthesia. |
|
Scientific Title of Study
|
Comparison of the clinical performance of the two second generation supraglottic airway devices (I-GEL VS AMBUAURAGAIN) in adult patients undergoing elective surgery. |
| 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 Ushma H Thakar |
| Designation |
Third Year Resident |
| Affiliation |
Smt NHL Municipal Medical College |
| Address |
Anesthesiology Department
Smt SCL general hospital
Saraspur cross road
Saraspur
Ahmedabad
Ahmadabad
GUJARAT
380018
India |
| Phone |
9909245913 |
| Fax |
|
| Email |
thakarushma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gauri M Panjabi |
| Designation |
Associate Professor |
| Affiliation |
Smt NHL Municipal Medical College |
| Address |
Anesthesiology Department
Smt SCL general hospital
Saraspur cross road
Saraspur
Ahmedabad
Ahmadabad
GUJARAT
380018
India |
| Phone |
9377244003 |
| Fax |
|
| Email |
gauripanjabi@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gauri M Panjabi |
| Designation |
Associate Professor |
| Affiliation |
Smt NHL Municipal Medical College |
| Address |
Anesthesiology Department
Smt SCL general hospital
Saraspur cross road
Saraspur
Ahmedabad
Ahmadabad
GUJARAT
380018
India |
| Phone |
9377244003 |
| Fax |
|
| Email |
gauripanjabi@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Smt SCL general hospital
Saraspur Cross Road
Saraspur
Ahmedabad
Gujarat
India
380018 |
|
|
Primary Sponsor
|
| Name |
Smt SCL general hospital |
| Address |
Saraspur cross road, saraspur, Ahmedabad. 380018 |
| Type of Sponsor |
Other [Corporation hospital] |
|
|
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 Ushma H Thakar |
Smt SCL general hospital |
6th floor surgery operation theater and 1st floor obs &gynec operation theater, Ahmedabad, Gujarat.
Ahmadabad
GUJARAT |
9909245913
thakarushma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NHL Institutional Review Board (NHLIRB) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: 1||Obstetrics, (3) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ambu AuraGain |
Second generation supraglottic airway device.The Ambu AuraGain is a newer second generation supraglottic airway device launched in June 2014.It can be used for surgeries of 120-140 minutes. It is a single use SAD made of polyvinyl chloride (PVC) and is anatomically curved in shape of human airway and provide high oropharyngeal seal  pressure. In addition, it has an integrated gastric access, a bite block, and a wider airway tube, which provide an intubation conduit. |
| Intervention |
I-gel |
Second generation supraglottic airway device. I-gel is a single use non-inflatable second generation supraglottic airway device designed to avoid compression trauma and has separate gastric channel. It has soft, gel like, non-inflatable cuff. The tip of the distal non-inflatable cuff lies in the proximal opening of the oesophagus, isolating the oesophageal opening from laryngeal inlet. The seal created is sufficient for both spontaneously breathing patients and for positive pressure ventilation. It can be used for surgeries of 120-140 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Elective surgeries
ASA grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
Mouth opening less then 2.5 cm
Full stomach
Hiatus hernia
Gatsro esophageal reflux disease
cervical spine disease
pharyngeal pathology
laryngeal pathology
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
QUALITY OF INSERTION
WORKING PERFORMANCE |
1) Easy or difficult insertion
2) Number of attempts required for insertion
3) Time taken for insertion
4) Oropharyngeal leak pressure after 10 minutes ofinsertion
5) Airway sealing quality score after 5 minutes of insertion
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PERIOPERATIVE HEMODYNAMIC PARAMETERS (PULSE RATE, SYSTOLIC BP, DIASTOLIC BP, MEAN BP, SPO2, ETCO2) |
At Baseline,
Before induction,
Immediately after insertion,
At 1 minute after insertion,
At 5 min after insertion,
At 10 minutes after insertion,
At 15 minutes after insertion. |
| POST OPERATIVE COMPLICATIONS |
Blood stained device,
Tongue-lip-dental trauma,
Sore throat,
Hoarseness of voice,
Bronchospasm or laryngospasm |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/08/2024 |
| Date of Study Completion (India) |
31/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
WE WILL START OUR STUDY AFTER WE GET CTRI APPROVAL. WE WANT TO COMPARE TWO SECOND GENERATION SUPRAGLOTTIC AIRWAY DEVICES IN ADULT PATIENTS BECAUSE THERE HAS BEEN MANY STUDIES DONE IN CHILDREN COMPARING I-GEL VERSUS AMBU AURAGAIN BUT VERY LESS DATA AVAILABEL FOR ADULT PATIENTS. |