| CTRI Number |
CTRI/2025/09/094549 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing performance of Laryngeal mask airways blockbuster and baska for patients undergoing elective surgery under general anaesthesia |
|
Scientific Title of Study
|
Comparison of performance characteristics of blockbuster and baska mask lma in patients undergoing elective surgery under general anaesthesia
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Malvika Kishore |
| Designation |
Junior Resident |
| Affiliation |
ESIC model hospital, Basaidarapur, New Delhi 110015, department of anaesthesiology, Ot building C block |
| Address |
G 73/1b Jagat Puri Delhi-51
East
DELHI
110051
India |
| Phone |
8586860161 |
| Fax |
|
| Email |
malvikakishore30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vijay Kumar nagpal |
| Designation |
Professor |
| Affiliation |
ESIC model hospital, Basaidarapur |
| Address |
Esic model hospital, department of anaesthesiology, C block old OT Building, New delhi
West
DELHI
110015
India |
| Phone |
9968304240 |
| Fax |
|
| Email |
nagpalvijaykumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Malvika Kishore |
| Designation |
Junior Resident |
| Affiliation |
ESIC model hospital, Basaidarapur |
| Address |
Esic model hospital, department of anaesthesiology, C block OT building
East
DELHI
110015
India |
| Phone |
8586860161 |
| Fax |
|
| Email |
malvikakishore30@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESI Hospital, Block W, Basai Dara pur, Bali Nagar, New Delhi, Delhi 110015, Department of Anaesthesiology , C Block OT Building |
|
|
Primary Sponsor
|
| Name |
Esic hospital, Basai Darapur |
| Address |
ESI, Hospital, block W, basaidarapur, delhi- 110015 |
| 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 |
| Dr Vijay Kumar nagpal |
ESIC, PGIMSR BASAIDARAPUR, DELHI |
ESI Hospital, Block W, Basai Dara pur, Bali Nagar, New Delhi, Delhi 110015, Department of Anaesthesiology , C Block OT Building
North West
DELHI |
9968304240
Nagpalvijaykumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ESI- PGIMSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patient with no comorbidities or any one or two we’ll controlled comorbidity ( ASA 1 & 2)
ICD-10-PCS Code: 3E0G3GC |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BASKA LMA |
Comparing Performance Characteristics
The Baska Mask is a third-generation supraglottic airway device that utilizes a self-sealing membranous cuff and non-inflatable design to optimize seal during spontaneous or controlled ventilation. It has integrated suction channels for pharyngeal and gastric drainage, reducing aspiration risk.
Although both devices are coded similarly in ICD-10-PCS due to procedural similarity, their clinical performance (e.g., seal pressure, ease of insertion, ventilation efficacy) forms the basis for comparison in this trial. |
| Intervention |
Blockbuster LMA |
Comparing Performance characteristics
The Blockbuster LMA is a second-generation supraglottic airway device designed for effective airway management during general anesthesia. It features a wide airway tube, drain tube for gastric access, and is equipped with a cuff designed to provide an effective seal for positive pressure ventilation. It also includes fiberoptic-guided intubation capability, making it suitable for difficult airways.
After induction of general anesthesia, the Baska Mask will be inserted according to manufacturer guidelines. Proper placement will be confirmed using standard clinical methods (capnography, chest auscultation, chest rise). The device will be used for airway management throughout the surgical procedure. |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 & 2
Mallampati 1 & 2
Elective Surgery of less than or equal to 2 hours |
|
| ExclusionCriteria |
| Details |
BMI more than 30 KG per M2
Mouth opening of less than 2
History of Gastroesophagial reflux disease
Known allergies to an aesthetic agents or devices |
|
|
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 time taken for successful insertion between blockbuster and baska LMA in patients undergoing elective surgery under general anaesthesia |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare number of insertion attempts
To compare requirement for manipulation
To compare oropharyngeal leak pressure
To compare successful gastric tube placement
To compare incidence of postoperative sore throat
To compare adequacy of placement using glottic exposure grading
To compare hemodynamic response during insertion & removal of device
|
Compare incidence of postoperative sore throat at baseline 2hours,4hours & 6hours.
Adequacy of placement using glottic exposure grading at baseline
Hemodynamic response during insertion & removal of device at baseline.
|
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/09/2025 |
| 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="0"
Months="11"
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
|
The proposed study will be conducted in the Department of anaesthesiology , esic- pgimsr, basaidarapur, New Delhi- 110015. A total of 108 patients will be enrolled for study and informed consent will be taken for comparison of performance characteristics of blockbuster and baska lma in patients undergoing elective surgery under general anaesthesia. |