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CTRI Number  CTRI/2025/08/093000 [Registered on: 13/08/2025] Trial Registered Prospectively
Last Modified On: 12/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two airway devices for maintaining seal during head rotation in patients under general anaesthesia. 
Scientific Title of Study   Comparison of oropharyngeal leak pressure of Proseal Laryngeal mask airway and i-gel plus at head rotation; a randomised controlled study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vandana kumari 
Designation  Post graduate student  
Affiliation  Maulana Azad Medical College  
Address  Room number 415, BL TANEJA BLOCK, 4th floor, Maulana Azad Medical College Central DELHI 110002 India

Central
DELHI
110002
India 
Phone  9625754424  
Fax    
Email  vandanarpvv@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Anju Romina Bhalotra 
Designation  Director Professor  
Affiliation  Maulana Azad Medical College  
Address  Room number 415, BL Taneja BLOCK, 4th Floor, Maulana Azad Medical College

Central
DELHI
110002
India 
Phone  9968604219  
Fax    
Email  drakgk@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Vandana kumari 
Designation  Post graduate student  
Affiliation  Maulana Azad Medical College  
Address  Room number 415, BL TANEJA BLOCK, 4th floor, Maulana Azad Medical College Central DELHI 110002 India

Central
DELHI
110002
India 
Phone  9625754424  
Fax    
Email  vandanarpvv@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Maulana Azad Medical College and associated hospitals  
Address  JLN Marg, New Delhi, 110002 
Type of Sponsor  Government medical college 
 
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 Vandana Kumari  Lok Nayak Hospital  Room No 415 Unit 3 Department of Anaesthesiology BL Taneja Block 4th Floor
Central
DELHI 		 9625754424

vandanarpvv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Maulana Azad Medical College and Associated Hospitals New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  i-gel plus LMA   For airway management under general anaesthesia in adult patients, after induction of anaesthesia LMA device i-gel plus will be inserted for airway management. Total duration of study - 1 year. 
Comparator Agent  Proseal Laryngeal mask airway  For airway management under general anaesthesia in adult patients, after induction of anaesthesia Proseal Laryngeal mask airway will be inserted for airway management. Total duration of study - 1 year. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  American Society of Anaesthesiologists physical status (ASA) I-III
BMI (Body Mass Index) 19-30 Kg/m² 
 
ExclusionCriteria 
Details  1. Any risk of gastric aspiration.
2. Underlying respiratory diseases.
3. Restricted neck movements. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean oropharyngeal leak pressure of Proseal Laryngeal mask airway and i-gel plus at 60° head rotation using manometer stability technique.  5 minutes after the placement of device. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Mean oropharyngeal leak pressure of Proseal Laryngeal mask airway and i-gel plus at 0°, 30° head rotation using manometer stability technique.
2. Fibreoptic view of vocal cords through Proseal Laryngeal mask airway and i-gel plus at 0°, 30° and 60° head rotation using Brimacombe score.
3. Mean maximum airway pressure during volume controlled ventilation using Proseal Laryngeal mask airway and i-gel plus at 0°, 30°, 60° head rotation.
4. Mean expired tidal volume during volume controlled ventilation using Proseal Laryngeal mask airway and i-gel plus at 0°, 30°, 60° head rotation. 		 5 minutes after the placement of device. 
 
Target Sample Size   Total Sample Size="154"
Sample Size from India="154" 
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)   01/09/2025 
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="1"
Months="0"
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 - NO
Brief Summary  
We are comparing oropharyngeal leak pressure (OLP) of two supraglottic airway devices- Proseal Laryngeal Mask Airway (PLMA) and i-gel Plus in adult patients under general anaesthesia with head positions at 0°, 30°, and 60° rotation. The aim of study is to compare oropharyngeal leak pressure of Proseal laryngeal mask airway and i-gel plus in head rotated positions. A total of 154 ASA I–III patients (18–60 years, BMI 19–30 kg/m²) will be randomized into PLMA and i-gel Plus groups. Standardised anaesthetic induction and device insertion will be performed, with measurements taken at each head position. OLP will be determined by manometer stability technique and fibreoptic views will be graded by Brimacombe score. Adverse outcomes such as sore throat or blood staining of device will be noted.
 
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