| CTRI Number |
CTRI/2026/01/101397 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
10/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between two medical devices in adult participants undergoing elective surgery. |
|
Scientific Title of Study
|
A prospective randomised study comparing the clinical performance of Proseal LMA and Baska Mask in adult patients undergoing elective surgery under general anaesthesia with controlled ventilation. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monika |
| Designation |
Junior Resident |
| Affiliation |
LLRM Medical College |
| Address |
Department of Anaesthesia
LLRM Medical College Meerut (Uttar Pradesh)
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8887739015 |
| Fax |
|
| Email |
mncgautam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vipin Kumar Dhama |
| Designation |
Professor |
| Affiliation |
LLRM Medical College Meerut |
| Address |
Department of Anaesthesia
LLRM Medical College
Meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9760014177 |
| Fax |
|
| Email |
drvipindhama@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Monika |
| Designation |
Junior Resident |
| Affiliation |
LLRM Medical College Meerut |
| Address |
Department of Anaesthesia
LLRM Medical College Meerut (Uttar Pradesh)
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8887739015 |
| Fax |
|
| Email |
mncgautam@gmail.com |
|
|
Source of Monetary or Material Support
|
| LLRM Medical College Meerut Uttar Pradesh 250004 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia |
| Address |
LLRM Medical College Meerut 250004 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Monika |
LLRM Medical College |
Department of Anaesthesia LLRM Medical College Meerut
Meerut
UTTAR PRADESH |
8887739015
mncgautam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Baska Mask |
Baska Mask ia made of silicone,has a self sealing membranous recoiling cuff that inflates and deflates with each positive pressure breath |
| Intervention |
laryngeal mask airways insertion |
comparing the hemodynamic changes in patients inserted with proseal-lma and baska mask airway |
| Comparator Agent |
Proseal LMA |
Proseal lma is a reusable device with an additional inflatable dorsal cuff, integrated bite block and a gastric drain tube |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 and 2 undergoing elective surgery in supine position under general anaesthesia |
|
| ExclusionCriteria |
| Details |
ASA Grade3/4
pregant patient
surgery duration more than 4 hours |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the clinical performance of both the LMA |
postoperatively complications to be assessed for 24 hours if any |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| number of attempts for successful insertion of device |
patients to be assessed for 24 hours postoperatively |
| orophayngeal seal pressure |
patients to be assessed for 24 hours postoperatively |
| complications if any |
patients to be assessed for 24 hours postoperatively |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/01/2026 |
| 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="4"
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 - NO
|
|
Brief Summary
|
This study is a prospective randomised study comparing the clinical efficacy of the Proseal LMA and Baska mask in adult patients undergoing elective surgeries in general anaesthesia with controlled ventilation.
we will be assessing number of attempts taken for successful insertion, oropharyngeal seal pressure, ease of insertion of device, hemodynamic parameters, and complications if any. |