FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/063834 [Registered on: 08/03/2024] Trial Registered Prospectively
Last Modified On: 27/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two different devices to maintain airway during laparoscopic gall bladder removal. 
Scientific Title of Study   Comparison of Proseal laryngeal mask airway and Baska mask in adult patients undergoing laparoscopic surgeries under general anaesthesia : Randomised control 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  Dr Simran Saroha 
Designation  Junior Resident (MD Anaesthesia) 
Affiliation  Teerthanker Mahaveer Medical College And Research Centre 
Address  Room No 204, 2nd Floor Teerthanker Mahaveer Medical College and Research Centre Moradabad Department Of Anaesthesiology

Moradabad
UTTAR PRADESH
244001
India 
Phone  7015040384  
Fax    
Email  drsimransaroha14@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pallavi Ahluwalia 
Designation  Professor 
Affiliation  Teerthanker Mahaveer Medical College And Research Centre 
Address  Room No 204, 2nd Floor Teerthanker Mahaveer Medical College and Research Centre Moradabad Department Of Anaesthesiology
Room No 204, 2nd Floor Teerthanker Mahaveer Medical College and Research Centre Department Of Anaesthesiology
Moradabad
UTTAR PRADESH
244001
India 
Phone  8218628850  
Fax    
Email  drpallaviahluwalia@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Simran Saroha 
Designation  Junior Resident (MD Anaesthesia) 
Affiliation  Teerthanker Mahaveer Medical College And Research Centre 
Address  Room No 204, 2nd Floor Teerthanker Mahaveer Medical College and Research Centre Moradabad Department Of Anaesthesiology
Room No 204, 2nd Floor Teerthanker Mahaveer Medical College and Research Centre Department Of Anaesthesiology
Moradabad
UTTAR PRADESH
244001
India 
Phone  7015040384  
Fax    
Email  drsimransaroha14@gmail.com  
 
Source of Monetary or Material Support  
Teerthanker Mahaveer Medical college , Moradabad , Uttar pradesh 
 
Primary Sponsor  
Name  Teerthanker Mahaveer Medical College , Moradabad , Uttar pradesh  
Address  Teerthanker Mahaveer Medical College , Moradabad , Uttar pradesh 
Type of Sponsor  Private 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 Simran Saroha  Teerthanker Mahaveer Medical College and Research Centre  Department Of Anaesthesiology Room No 204, 2nd Floor Teerthanker Mahaveer Medical College and Research Centre UP 244001
Moradabad
UTTAR PRADESH 		 7015040384

drsimransaroha14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE , T. M. UNIVERSITY , MORADABAD , UTTAR PRADESH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Baska mask  To compare -ease of insertion -oropharyngeal leak pressure 
Comparator Agent  Proseal laryngeal mask airway   To compare -ease of insertion -oropharyngeal leak pressure  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adult patients of the American Society of Anaesthesiologists physical status I and II , mallampati score 1 and 2 , scheduled to undergo laparoscopic surgeries under general anaesthesia , informed and written consent  
 
ExclusionCriteria 
Details  Adult patients with anticipated difficult airway, BMI more than 30kg/m2, high risk of aspiration and pregnancy, operation time more than 4 hours , cervical spine pathology 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome to be assessed

1.To compare oropharyngeal leak pressure in both the groups.
2.To compare ease of insertion in both the groups.
 		 5 minutes,15 minutes, 20 minutes after pneumoperitoneum 
 
Secondary Outcome  
Outcome  TimePoints 
Each participant in the study will be assessed for following Secondary outcome parameters are as follows :-
1.To note the number of attempts of insertion in both the groups.
2.To measure insertion time in both the groups.
3. to note the anatomical alignment of supraglottic device in both the groups.
4.To compare the hemodynamic parameters in both the groups.
5.To assess and compare any complication in both the groups.
 		 Will be monitored before insertion of device upto 30 minutes and thereafter every 15 minutes till the completion of surgery. 
 
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)   20/03/2024 
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="1"
Months="3"
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  drsimransaroha14@gmail.com

  6. For how long will this data be available start date provided 01-05-2024 and end date provided 23-04-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This study is planned in context that supraglottic third generation device Baska mask is recently introduced in clinical uses and there are limited number of comparative clinical studies available to compare second generation Proseal laryngeal mask airway and Baska mask efficacy , oropharyngeal leak pressure , ease of insertion , hemodynamic profile, anatomical alignment and complication of both devices in adult patients undergoing laparoscopic surgeries under general anaesthesia. 
Close