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CTRI Number  CTRI/2025/11/097430 [Registered on: 13/11/2025] 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 Trial 
Public Title of Study   A comparison of two airway management devices i.e. GMA-Tulip and i-gel in adult patients undergoing general anaesthesia 
Scientific Title of Study   A prospective randomized comparison of GMA-Tulip versus i-gel in adult patients undergoing 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 Prashant Kumar  
Designation  Professor  
Affiliation  Pt. B.D. Sharma PGIMS, Rohtak 
Address  Department of Anaesthesiology and Critical Care, Pt. B.D. Sharma PGMIS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  9416336901  
Fax    
Email  Pk.pgims@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ananya Bansal 
Designation  Junior Resident  
Affiliation  Pt. B.D. Sharma PGIMS, Rohtak 
Address  Department of Anaesthesiology and Critical Care, Pt. B.D. Sharma PGMIS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  9899953548  
Fax    
Email  ananyab1999@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ananya Bansal 
Designation  Junior Resident  
Affiliation  Pt. B.D. Sharma PGIMS, Rohtak 
Address  Department of Anaesthesiology and Critical Care, Pt. B.D. Sharma PGMIS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  9899953548  
Fax    
Email  ananyab1999@gmail.com  
 
Source of Monetary or Material Support  
Pandit B.D. Sharma Univeristy, PGIMS Rohtak, Haryana 124001 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ananya Bansal   Pt. B.D. Sharma, PGIMS  Department of Anaesthesiology and Critical Care, Modular OT Complex, Second Floor, PGIMS Rohtak Rohtak HARYANA
Rohtak
HARYANA 		 9899953548

ananyab1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee Pt BD Sharma PGIMS Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  GMA- Tulip  An appropriate size of LMA i.e. GMA Tulip (size 3 or 4) will be selected as per manufacturer’s recommendation according to weight. Airway device will be checked before use as recommended and will be lubricated with water-based gel. Airway devices will be introduced using the standard technique for insertion. Correct placement of the device will be confirmed by chest auscultation, and display of a square wave capnography trace. The oropharyngeal leak pressure will be measured by taking the patient on manual ventilation mode, closing the APL valve of the circle system at 30 cmH20 and fixed gas flow of 3 L/min and recording the airway pressure at which an audible air leak is observed. The OLP will be measured after LMA insertion (T0) and also one hour after the surgery (T1). 
Comparator Agent  i - gel   An appropriate size of LMA i.e. i-gel (size 3 or 4) will be selected as per manufacturer’s recommendation according to weight. Airway device will be checked before use as recommended and will be lubricated with water-based gel. Airway devices will be introduced using the standard technique for insertion. Correct placement of the device will be confirmed by chest auscultation, and display of a square wave capnography trace. The oropharyngeal leak pressure will be measured by taking the patient on manual ventilation mode, closing the APL valve of the circle system at 30 cmH20 and fixed gas flow of 3 L/min and recording the airway pressure at which an audible air leak is observed. The OLP will be measured after LMA insertion (T0) and also one hour after the surgery (T1). 
Comparator Agent  To compare the clinical performance and safety profile of GMA Tulip and i-gel supraglottic airway devices in adult patients undergoing elective surgery under general anaesthesia.  Patients undergoing surgery under general anaesthesia will be intubated under all standard operating protocols using an appropriate size of LMA, either GMA Tulip or i-gel. Measurement of Oropharyngeal Leak Pressure, number of attempts taken for intubation, time taken for intubation, first pass success rate, ease of intubation, evaluation of device placement by fibreoptic grading, haemodynamic variations and postoperative patient comfort will be noted. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  One hundred patients of either sex aged 18-60 years belonging to
American Society of Anaesthesiologists (ASA) physical status I or II scheduled for
elective surgery under general anaesthesia where placement of supraglottic device is
indicated will be included in the study 
 
ExclusionCriteria 
Details  Patients having respiratory or pharyngeal pathology, mouth
opening less 2.0cms, Body mass index more 30kgm-2, pregnancy, full stomach, will be
excluded from the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the oropharyngeal leak
pressure as a measure of placement and airway seal
 		 1. 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.
MAP, HR, Sp02 will be evaluated at baseline, after induction, after device placement and 5 minutes after device placement 
 
Secondary Outcome  
Outcome  TimePoints 
Assess the time taken for device placement, the ease of insertion & first-attempt
success rate
Evaluate the device placement by fibreoptic grading
Compare haemodynamic responses to device insertion.
Assess the postoperative patient comfort
 		 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="100"
Sample Size from India="100" 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kiranpreet72@rediffmail.com].

  6. 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.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This study is to compare the clinical performance of two supraglottic devices i.e. GMA-Tulip and i-gel. Adult patients aged between 18-60 years of either sex of ASA grade 1 and 2 scheduled for elective surgery requiring general anaesthesia and endotracheal intubation will be included. Oropharyngeal Leak Pressure, Number of attempts, time taken for intubation, first pass, success rate of intubation, ease of intubation, optimisation manoeuvres required for intubation and haemodynamic variations after induction, after insertion and five minutes after the device placement will be noted. Data will be compiled and appropriate statistical test will be used to analyze the results.

 
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