| CTRI Number |
CTRI/2025/10/096379 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of ProSeal Laryngeal Mask Airway Placement from Head End versus Front End on Insertion Time and Ease among Adult Patients Undergoing Elective Surgery under General Anaesthesia. |
|
Scientific Title of Study
|
Comparative Evaluation of Placement Characteristics of Proseal
Laryngeal Mask Airway from Head End and Front End 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 |
Dr Mohit Singh Tanwar |
| Designation |
PG resident |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of anaesthesia and intensive care, VMMC and Safdarjung hospital, Ansari
Nagar east, New Delhi,
Address
New Delhi
DELHI
110029
India
South
DELHI
110029
India |
| Phone |
9315057755 |
| Fax |
|
| Email |
mohit32tanwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Panwar |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of anaesthesia and intensive care, VMMC and Safdarjung hospital, Ansari
Nagar east, New Delhi,
Address
New Delhi
DELHI
110029
India
South
DELHI
110029
India |
| Phone |
9013000543 |
| Fax |
|
| Email |
drmkumath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Panwar |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of anaesthesia and intensive care, VMMC and Safdarjung hospital, Ansari
Nagar east, New Delhi,
Address
New Delhi
DELHI
110029
India
South
DELHI
110029
India |
| Phone |
9013000543 |
| Fax |
|
| Email |
drmkumath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir medical college and Safdarjung hospital ,Ansari
Nagar east, New Delhi,
Address
New Delhi
DELHI
110029
India |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of anaesthesia and intensive care, VMMC and Safdarjung hospital, Ansari
Nagar east, New Delhi,
Address
New Delhi
DELHI
110029
India |
| 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 Mohit Singh Tanwar |
Vardhman Mahavir medical college and Safdarjung hospital |
Department of anaesthesia and intensive care, VMMC and Safdarjung hospital, Ansari
Nagar east, New Delhi,
Address
New Delhi
DELHI
110029
India
South
DELHI |
9315057755
mohit32tanwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir medical college and Safdarjung hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Front end. |
Insertion of ProSeal Laryngeal Mask Airway (PLMA) using the stylet-guided technique from the front end of the patient in which the anaesthesiologist will be standing lateral to the OT table. |
| Comparator Agent |
Head end |
Insertion of ProSeal Laryngeal Mask Airway (PLMA) using the stylet-guided technique from the head end of the patient in which the anaesthesiologist will be standing on the head end of the patient . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient aged between 18 to 65 years of physical status ASA I and II with Mallampati class I and II. |
|
| ExclusionCriteria |
| Details |
Patients with anticipated difficult airway, gastroesophageal reflux or oropharyngeal mass, pregnancy, or obesity (BMI more than 30 kg per m²) . |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome measure will be the insertion time, defined as the time taken from start of
introduction of device inside mouth to the presence of square wave capnography. |
The primary outcome measure will be the insertion time, defined as the time taken from start of
introduction of device inside mouth to the presence of square wave capnography. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•correct placement of PLMA (ease of drain tube placement) ( grade 1 easy, grade 2 difficult,
grade 3 unable to pass)
•Number of insertion attempts
•Number of manoeuvres like jaw thrust, head tilt
•Ease of insertion, rated on a 5-point likert scale (1 = very difficult, 2 = difficult, 3 = normal ,
4 = easy, 5 = very easy)
•Monitor hemodynamic responses at baseline, at time of insertion, 1 minutes post insertion, 5
minutes post insertion like HR, MAP. |
At time of insertion, 1 minute post insertion and 5 minutes post insertion |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
03/11/2025 |
| 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="1"
Months="6"
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 thesis is a prospective, randomized controlled trial comparing the ease, time, and safety of ProSeal Laryngeal Mask Airway placement from the head end versus the front end in adult patients undergoing elective surgery under general anaesthesia. |