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CTRI Number  CTRI/2024/10/074918 [Registered on: 08/10/2024] Trial Registered Prospectively
Last Modified On: 07/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Airway interventions in participants posted for elective surgery under general anaesthesia 
Scientific Title of Study   Comparison of new generation Baska mask with LMA Protector in elective surgery under general anaesthesia: A Randomized 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  sonam patel 
Designation  Assistant Professor 
Affiliation  AIIMS gorakhpur 
Address  1st floor, OT complex, AIIMS Gorakhpur, Kunraghat, Gorakhpur
1st floor, OT complex, AIIMS Gorakhpur, Kunraghat, Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India 
Phone  09007146734  
Fax    
Email  2009mbbs.sonam@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  sonam patel 
Designation  Assistant Professor 
Affiliation  AIIMS gorakhpur 
Address  1st floor, OT complex, AIIMS Gorakhpur, Kunraghat, Gorakhpur
1st floor, OT complex, AIIMS Gorakhpur, Kunraghat, Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India 
Phone  09007146734  
Fax    
Email  2009mbbs.sonam@gmail.com  
 
Details of Contact Person
Public Query  
Name  sonam patel 
Designation  Assistant Professor 
Affiliation  AIIMS gorakhpur 
Address  1st floor, OT complex, AIIMS Gorakhpur, Kunraghat, Gorakhpur
1st floor, OT complex, AIIMS Gorakhpur, Kunraghat, Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India 
Phone  09007146734  
Fax    
Email  2009mbbs.sonam@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Gorakhpur, kunraghat, Gorakhpur-273008, India 
 
Primary Sponsor  
Name  AIIMS Gorakhpur 
Address  1st floor, OT complex, AIIMS Gorakhpur, Kunraghat, Gorakhpur-273008, 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 
Dr sonam patel  AIIMS Gorakhpur  Department of anaesthesia, 1st floor, near OT complex, kunraghat, Gorakhpur-273008
Gorakhpur
UTTAR PRADESH 		 9007146734

2009mbbs.sonam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (2) ICD-10 Condition: K929||Disease of digestive system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  BASKA Mask  used for ventilation in elective surgery after general anaesthesia for duration of approximately 60-180 minutes 
Intervention  LMA Protector  used for ventilation in elective surgery after general anaesthesia for duration of approximately 60-180 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA I and II, who are scheduled for routine elective surgeries under general anaesthesia.
 
 
ExclusionCriteria 
Details  Patient’s refusal,
difficult airway,
High Body mass index
Patients with neck pathology
Pregnant females,
Patients at increased risk of gastric aspiration.
laparoscopic surgery
Emergency surgery 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare oropharyngeal seal pressure (OLP) while using LMA ProtectorTM and Baska mask at various time intervals
 		 To compare oropharyngeal seal pressure (OLP) at 10, 20, 30, 60 minutes interval
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the ease of insertion of each device in terms of time taken and number of attempts per device insertion.

To compare leak fraction by using either LMA ProtectorTM or Baska mask.

To compare the intra-operative haemodynamic changes using either device at various time

Any post-operative complications hoarseness, sore throat or dysphagia.
 		 immediately after insertion and every 5 minutes till 30 minutes
 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   20/10/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - Informed Consent Form
    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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [2009mbbs.sonam@gmail.com].

  6. For how long will this data be available start date provided 10-09-2025 and end date provided 10-10-2028?
    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   Since the LMA ProtectorTM was introduced as the most advanced second generation of LMA devices, and studies has shown its superiority in terms of orppharyngeal leak pressure as compared to other second generation devices3. Whereas various studies have shown that the oropharyngeal seal formed by the baska mask is superior when compared to other supraglottic devices used commonly these days. However there is no study comparing these two so we wanted to evaluate oropharyngeal leak pressure among these two new devices.In this study we aim to compare the Baska mask with the LMA ProtectorTM in terms of quality of insertion, quality of ventilation and incidence of post-operative complications 
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