| CTRI Number |
CTRI/2020/01/022633 [Registered on: 07/01/2020] Trial Registered Prospectively |
| Last Modified On: |
11/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [supraglottic airway device] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF CLINICAL PERFORMANCE OF THREE SUPRAGLOTTIC AIRWAY DEVICES IN ADULT PATIENTS DURING GENERAL ANAESTHESIA. |
|
Scientific Title of Study
|
COMPARISON OF CLINICAL PERFORMANCE OF I-GEL, LMA SUPREME AND AMBU AURA GAIN IN ADULT PATIENTS DURING 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 |
Tejashri Chinthavali |
| Designation |
junior resident |
| Affiliation |
king george medical university lucknow |
| Address |
room no.D201 Gautam buddha hostel
kgmu, lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8778264915 |
| Fax |
|
| Email |
tejurao.9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
TANMAY TIWARI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
king george medical university lucknow |
| Address |
DEPARTMENT OF ANAESTHESIA, KGMU, LUCKNOW
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9452526270 |
| Fax |
|
| Email |
tanmayanesthesia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lakshmi Tejashri C |
| Designation |
junior resident |
| Affiliation |
king george medical university lucknow |
| Address |
room no.D201, Gautam buddha hostel
kgmu, lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8778264915 |
| Fax |
|
| Email |
tejurao.9@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
LAKSHMI TEJASHRI C |
| Address |
201 D , GAUTAM BUDDHA HOSTEL, KGMU, CHOWK, LUCKNOW. |
| Type of Sponsor |
Other [self] |
|
|
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 TEJASHRI |
KING GEORGE MEDICAL COLLEGE |
DEPARTMENT OF ANAESTHESIA,KING GEORGE MEDICAL COLLEGE, CHOWK, LUCKNOW.
Lucknow
UTTAR PRADESH |
8778264915
tejurao.9@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: K806||Calculus of gallbladder and bile duct with cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
supraglottic airway device |
Ambu Aura gain- at the time of study only once |
| Intervention |
supraglottic airway device |
igel- only once at the time of study |
| Intervention |
supraglottic airway device |
LMA supreme- at the time of study only once |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient posted for laparoscopic cholecystectomy and other laparoscopic procedures |
|
| ExclusionCriteria |
| Details |
Patients negative consent to be part of study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| clinical performance for successful insertion of the supraglottic airway device. |
at the basline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| OROPHARYNGEAL LEAK PRESSURE |
1 HOUR |
| EASE OF INSERTION |
5 MINUTES |
| REQUIRED ATTEMPTS OF INSERTION |
1 HOUR |
| REQUIRED ATTEMPTS OF GASTRIC TUBE PLACEMENT. |
1 HOUR |
| QUALITY OF AIRWAY WITH CONTROLLED VENTILATION DURING THE MAINTENANCE OF ANAESTHESIA. |
1 HOUR. |
| COMPLICATIONS. |
5 HOURS |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/01/2020 |
| Date of Study Completion (India) |
10/08/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NOT YET. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
As there are many supraglottic airways used widely for airway management during general anaesthesia, the aim of this study is to prove the clinical performance of three supraglottic airway devices i.e. the LMA Supreme, Ambu Aura gain and i-gel in adult patients in general anaesthesia. Subjects will be ASA I patients for elective surgery who will be randomly allocated into the i-gel group, LMA Supreme group and the Ambu Aura Gain group. We will compare the time for successful insertion in the first attempt as the primary outcome, and the secondary outcomes will be ease of insertion, oropharyngeal leak pressures, required attempts for SAD insertion, requires attempts for gastric tube placement, quality of airway with controlled ventilation during maintenance of anaesthesia and any associated complications. Our results will suggest the better alternative of the supraglottic airway device in comparison with the others which will be based on the clinical performance of the supraglottic airway devices. |