| CTRI Number |
CTRI/2025/10/096417 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two types of breathing tubes (LMA supreme and I-gel) to see which one is easier for beginners to insert on the first try |
|
Scientific Title of Study
|
Laryngeal Mask Airway Supreme vs I gel A Comparison Of First Attempt Success Rate Among Novices |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Venkata Padmavathi G |
| Designation |
Postgraduate |
| Affiliation |
Srm Medical College Hospital And Research Institute |
| Address |
Department of Anaesthesiology Srm Medical College Hospital Potheri Kattankulathur Kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9710583696 |
| Fax |
|
| Email |
padmanaidu1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K Karthik |
| Designation |
Associate Professor |
| Affiliation |
SRM Medical College Hospital And Research Instiute |
| Address |
Department of Anaesthesiology Srm Medical College Hospital Potheri Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9444586662 |
| Fax |
|
| Email |
karthikk1@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
K Karthik |
| Designation |
Associate Professor |
| Affiliation |
SRM Medical College Hospital And Research Instiute |
| Address |
Department of Anaesthesiology Srm Medical College Hospital Potheri Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9444586662 |
| Fax |
|
| Email |
karthikk1@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| Room no 1, B block, Department of Anaesthesiology Potheri Kattankulathur 603203 Kancheepuram TAMIL NADU |
|
|
Primary Sponsor
|
| Name |
SRM Medical College Hospital |
| Address |
Room no 1, B block, Department of Anaesthesiology Potheri Kattankulathur 603203 Kancheepuram TAMILNADU |
| Type of Sponsor |
Research institution and 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 Venkata Padmavathi G |
SRM Medical College Hospital and Research Centre |
Room no 101, B block, Department Of Anaesthesiology, Surgery division SRM Medical College Hospital Potheri Kattankulathur
Kancheepuram
TAMIL NADU |
9710583696
padmanaidu1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z006||Encounter for examination for normal comparison and control in clinical research program, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
I-gel |
A second generation supraglottic airway device with non inflatable cuff used as a comparator to assess performance against LMA supreme in terms of first attempt success rate among novice users |
| Intervention |
LMA Supreme |
A second generation supraglottic airway device with gastric access being evaluated for ease of insertion and first attempt success rate among novice users during short procedures |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients assessed under ASA 1 ASA2
Patients undergoing surgery under general anesthesia
Weight of patients between 30kg to 100kg |
|
| ExclusionCriteria |
| Details |
Patients who refuse to participate in the study
Known or anticipated difficult airway(RODS criteria)
Surgery prolonging more than 45 minutes
Full stomach patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the first attempt success rate among novices between LMA supreme and I-gel in patients undergoing elective procedures under general anesthesia |
To compare the first attempt success rate among novices between LMA supreme and I-gel in patients undergoing elective procedures under general anesthesia during induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare insertion time, overall success rate |
intraoperative period |
| To compare oropharyngeal leak pressure |
Immediately post insertion |
| To compare ease of ryles tube insertion and airway complications |
During placement and within two hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
02/11/2025 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The study will be conducted post approval from IEC and CTRI. Patients will be hospitalised the day before surgery and instructed to fast for 6 hours (for solids) and 4 hours (for liquids) prior to the procedure. Inj Pantaprazole 40mg IV and Inj Metaclopramide 10mg IV will be administered 30 minutes prior to surgery. In the OT, infusion of ringer lactate will be started. Patients will be connected to a multichannel monitor displaying electrocardiography, oxygen saturation, non invasive blood pressure and end tidal carbon dioxide. Leak pressure will also be monitored. All the patients will be administered Inj Glycopyrrolate 0.2mg IV, Inj Midazolam 1mg IV, Inj Fentanyl 2mcg/kg IV. Preoxygenation will be done for 3 minutes. All the patients will be induced with Inj Propofol 2mg/kg IV in slow incremental dose and ease of mask ventilation will be noted. Selection of the size of LMA supreme and I-gel will be on the bases of the weight of the patient. The SAD’s will be inserted as per manufacturer’s user booklet. Adequate ventilation will be confirmed by chest movements and EtCO2 waveforms. Time of insertion will be defined from the removal of face mask to the time where adequate ventilation was established through SAD with capnographic confirmation. Complications including airway injury, laryngospasm and sore throat will be noted. |