| CTRI Number |
CTRI/2025/11/097445 [Registered on: 14/11/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| 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
|
Comparison of two airway devices in patients undergoing surgery under general anaesthesia |
|
Scientific Title of Study
|
A Comparative evaluation of performance of newer cuffless supraglottic devices: GMA Tulip versus SLIPA3G:A prospective randomised study in adults patients undergoing surgery under general anaesthesia |
| 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 Kiranpreet Kaur |
| Designation |
Professor |
| Affiliation |
Pt.B.D. Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, Pt. B.D. Sharma, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9992249436 |
| Fax |
|
| Email |
kiranpreet72@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Bindal |
| Designation |
Junior resident |
| Affiliation |
Pt.B.D. Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, Pt. B.D. Sharma, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9634525474 |
| Fax |
|
| Email |
agarwalbindal45@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Bindal |
| Designation |
Junior resident |
| Affiliation |
Pt.B.D. Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, Pt. B.D. Sharma, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9634525474 |
| Fax |
|
| Email |
agarwalbindal45@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. B.D. Sharma, PGIMS Rohtak, Haryana,124001 |
|
|
Primary Sponsor
|
| Name |
Pt. B.D. Sharma, PGIMS Rohtak, Haryana |
| Address |
Pt. B.D. Sharma, PGIMS Rohtak, Haryana,124001 |
| 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 Divya Bindal |
Pt. B.D. Sharma, PGIMS Rohtak |
Department of Anaesthesiology and critical care, Modular OT Complex, second floor, Pt. B.D. Sharma, PGIMS
Rohtak
HARYANA |
9634525474
agarwalbindal45@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pt B D Sharma PGIMS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z138||Encounter for screening for otherspecified diseases and disorders, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GMA-Tulip |
An appropriate size of GMA-Tulip will be selected as per weight. Airway device will be lubricated with water based gel before use and will be introduced by standard technique of intubation. Oropharyngeal leak pressure will be measured by taking patient on mechanical ventilation, closing the APL valve at 30cm H2O and fixed gas flow at 3L/min and recording the pressure at audible air leak. OLP will be noted at insertion of LMA and one hour after surgery. |
| Comparator Agent |
SLIPA 3G |
An appropriate size of SLIPA 3G will be selected as per weight. Airway device will be lubricated with water based gel before use and will be introduced by standard technique of intubation. Oropharyngeal leak pressure will be measured by taking patient on mechanical ventilation, closing the APL valve at 30cm H2O and fixed gas flow at 3L/min and recording the pressure at audible air leak. OLP will be noted at insertion of LMA and one hour after surgery. |
| Comparator Agent |
To compare oropharyngeal leak pressure between GMA-Tulip and SLIPA3G |
Patients undergoing general anaesthesia will be intubated under all standard operating protocols using supraglottic airway devices i.e. SLIPA3G & GMA-Tulip. Oropharyngeal leak pressure, time taken for intubation, first attempt success, ease of device placement, fibreoptic grading of device placement will be noted |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patient aged between 18 to 60 years, having ASA status I or II and patients undergoing surgery under general anaesthesia where placement of supraglottic device is indicated |
|
| ExclusionCriteria |
| Details |
Respiratory or Pharyngeal pathology
Mouth opening less than 2 cm
BMI more than 30kg/m2
Pregnancy
Full stomach |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare oropharyngeal leak pressure between GMA-Tulip and SLIPA3G |
The performace of Two gadgets will be compared after insertion, throughout the operative procedure and removal of device. surgical period may last from one hour to 2 hours. Mean arterial pressure, Heart rate, Sp02 will be evaluated at baseline, after induction, after device placement and 5 minutes after device placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time taken for device placement
First attempt success rate of two devices
Ease of device placement
Fibreoptic grading of device placement
Postoperative patient comfort & satisfaction related to airway device |
Outcome will be assessed after induction, after insertion, after device placement & 5 minutes after device placement Mean arterial pressure, Heart rate, Sp02 will be evaluated at baseline, after induction, after device placement & 5 minutes after device placement |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2026 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response - Analytic Code
Response - None of the above
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kiranpreet72@rediffmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is to compare the oropharyngeal leak pressure between two supraglottic devices SLIPA3G and GMA-Tulip in 18-60year ASA I and II patients undergoing surgery under general anaesthesia. Time taken for device placement, first attempt success rate of two devices, ease of device placement, fibreoptic grade of device placement and hemodynamic variations will be studied. Data will be compiled and appropriate stastical test will be used to analyse the results. |