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CTRI Number  CTRI/2024/03/063693 [Registered on: 06/03/2024] Trial Registered Prospectively
Last Modified On: 26/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia
Other (Specify) [supraglottic airway devices]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Which among the airway devices—I-Gel®, Blockbuster®, and Baska Mask—provides better sealing pressure in elderly patients under general anesthesia? 
Scientific Title of Study   Comparison of oropharyngeal leak pressure between the I-gel®, Blockbuster® and Baska Mask supraglottic airway devices during general anaesthesia in the elderly population. A randomised controlled trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sovan Kumar Subudhi 
Designation  Junior Resident 
Affiliation  AIIMS PATNA 
Address  Department of Anaesthesiology,OT Complex, 5th floor,AIIMS Patna Phulwari Sharif,Patna

Patna
BIHAR
801507
India 
Phone  9439691500  
Fax    
Email  sovan.subudhi9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrRajnish Kumar 
Designation  Additional Professor 
Affiliation  AIIMS PATNA 
Address  Department of Anaesthesiology,OT Complex, 5th floor,AIIMS Patna Phulwari Sharif,Patna

Patna
BIHAR
801507
India 
Phone  7783865337  
Fax    
Email  drrajnishkumar@aiimspatna.org  
 
Details of Contact Person
Public Query
 
Name  DrRajnish Kumar 
Designation  Additional Professor 
Affiliation  AIIMS PATNA 
Address  Department of Anaesthesiology,OT Complex, 5th floor,AIIMS Patna Phulwari Sharif,Patna

Patna
BIHAR
801507
India 
Phone  7783865337  
Fax    
Email  drrajnishkumar@aiimspatna.org  
 
Source of Monetary or Material Support  
Department of anaesthesiology, All India Institute of Medical Sciences,Patna, Phulwarisharif,Bihar,India pin:801507 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences ,Patna 
Address  Department of Anaesthesiology,OT Complex, 5th floor,AIIMS Patna Phulwari Sharif,Patna Patna BIHAR 801507 India 
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 
DrSovan Kumar Subudhi  All India Institute of Medical Sciences,Patna  Room No. 505, IPD 5th floor, OT complex, AIIMS Patna Patna BIHAR 801507 India.
Patna
BIHAR 
9439691500

sovan.subudhi9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,AIIMS PATNA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Age 65yrs ASA physical status I-II Elective surgery under General Anaesthesia with anticipated duration of 2hrs in supine position  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  I-Gel®  Oropharyngeal leak pressure will be measured by closing the pressure release valve and opening fresh gas flow at 3 L/minute.Two readings of oropharyngeal leak pressure and peak pressure will be taken, one after 5 minutes of the insertion of SADs (T1) and the other 20 minutes after insertion (T2) with flow at 2 L/min. 
Intervention  Baska Mask  Oropharyngeal leak pressure will be measured by closing the pressure release valve and opening fresh gas flow at 3 L/minute.Two readings of oropharyngeal leak pressure and peak pressure will be taken, one after 5 minutes of the insertion of SADs (T1) and the other 20 minutes after insertion (T2) with flow at 2 L/min. 
Intervention  Blockbuster®  Oropharyngeal leak pressure will be measured by closing the pressure release valve and opening fresh gas flow at 3 L/minute.Two readings of oropharyngeal leak pressure and peak pressure will be taken, one after 5 minutes of the insertion of SADs (T1) and the other 20 minutes after insertion (T2) with flow at 2 L/min. 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Age more than 65 years
ASA physical status I and II
Elective surgery under General anesthesia with anticipated duration of less than 2 hours in supine position
 
 
ExclusionCriteria 
Details  Laparoscopic surgery
Reduced mouth opening (interincisor distance less than 4cm)
Recent history of upper respiratory tract infection
Body mass index of more than 35
severe symptomatic oesophageal reflux diseases
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the Oropharyngeal leak pressure of I-gel®, Blockbuster® and Baska Mask supraglottic airway devices during general anaesthesia in the elderly population  5 minutes after supraglottic airway devices
20 minutes after supraglottic airway devices 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate and compare
The insertion time
Fibreoptic scoring (brimacombe scoring)
The peak pressure
Number of attempts
Maneuvers used during insertion
The intraoperative and postoperative anaesthesia related problems
 
intraoperative  
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
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   Phase 4 
Date of First Enrollment (India)   14/03/2024 
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="2"
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  

     This study is a randomized controlled trial regarding the comparison of oropharyngeal leak pressure between the I-Gel®, Blockbuster®, and Baska Mask supraglottic airway devices during general anaesthesia in the elderly population.The elderly population often presents unique challenges during general anaesthesia due to age-related anatomical and physiological changes.Oropharyngeal leak pressure (OLP) is an essential indicator of airway seal and is directly correlated with successful ventilation during general anesthesia. Limited research has been conducted to compare the oropharyngeal leak pressure of different supraglottic airway devices, specifically in the elderly population undergoing general anesthesia.The sample size was calculated based on the study by Chi et al.; a sample size of 108 patients (36 per group) will be taken, considering dropouts and errors in the sample size calculation.convenient sampling1. The primary objective is to compare the oropharyngeal leak pressure between I-gel®, Blockbuster®, and Baska Mask during general anaesthesia among the elderly age group, and the secondary objective is to evaluate and compare the insertion time,the peak pressure, the number of manoeuvres used during insertion, and the intraoperative and postoperative anesthesia-related problems.The inclusion criteria include patients over 65 years of age, ASA physical status I–II,elective surgery under GA with an anticipated duration of <2 hours in the supine position, and the exclusion criteria exclude patients undergoing laparoscopic surgery,reduced mouth opening (interincisor distance <4 cm), recent history of upper respiratory tract infection, BMI > 35, and severe symptomatic esophageal reflux diseases.

     Patients meeting the inclusion criteria will be transferred to the operating room (OR).Upon arriving inside the OR, all standard ASA monitors will be attached, and recording of the baseline hemodynamic parameters will be noted.Before inducing the patient, sealed opaque envelopes with allocated groups will be handed over to the anesthesiologist, and the patient will be induced under general anesthesia. An appropriate size of SADs (as per the group allocated) will be inserted. . The size of the SADs will be selected according to the weight of the patient as per the manufacturer’s recommendation. When an audible leak is detected and/or the pressure gauge on the anaesthesia machine displays a stable airway pressure, the value will be recorded as the sealing pressure has been reached. Oropharyngeal leak pressure will be measured by closing the pressure release valve and opening fresh gas flow at 3 L/minute. They won’t be permitted to go over 40 cm H2O. .Two readings of OLP and peak pressure will be taken, one after 5 minutes of insertion of SADs (T1) and the other 20 minutes after insertion.(T2)

 
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