| CTRI Number |
CTRI/2026/02/103812 [Registered on: 13/02/2026] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This is a study to test the efficacy of using methods to select the size of pLMA |
|
Scientific Title of Study
|
Efficacy of USG guided hyomental
distance measurement vs classical weight
based method for pLMA size selection in
adult patients undergoing elective surgery
: A randomized prospective study |
| 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 Vineet kumar |
| Designation |
Associate Proffessor |
| Affiliation |
Pt BD Sharma PGIMS Rohtak |
| Address |
Room 22,Second Floor,Department of Anaesthesia Modular OT Complex PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9416904050 |
| Fax |
|
| Email |
vineetkumar.pgims@uhsr.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramneesh |
| Designation |
Junior Resident |
| Affiliation |
Pt BD Sharma PGIMS Rohtak |
| Address |
Room 22,Second Floor,Department of Anaesthesia Modular OT Complex PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9518693534 |
| Fax |
|
| Email |
ramneeshgrover04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramneesh |
| Designation |
Junior Resident |
| Affiliation |
Pt BD Sharma PGIMS Rohtak |
| Address |
Room 22,Second Floor,Department of Anaesthesia Modular OT Complex PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9518693534 |
| Fax |
|
| Email |
ramneeshgrover04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia Modular OT complex PT BD Sharma PGIMS Rohtak Haryana 124001 |
|
|
Primary Sponsor
|
| Name |
Department Of Anaesthesia |
| Address |
2nd Floor Modular OT complex PT BD Sharma PGIMS
|
| 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 Ramneesh |
Pt B. D. Sharma, PGIMS, Rohtak |
Department of Anaesthesia, Modular OT complex, 2nd floor, room no. 22
Rohtak
HARYANA |
9518693534
Ramneeshgrover04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Classical weight based selection of pLMA |
In this group size of pLMA will be selected according to standard classical weight based method.The procedure takes approximately 5-10 minutes per patient. |
| Intervention |
USG guided hyomental distance based selection of pLMA |
In this group,the size ofpLMA will be selected based on USG guided measurement of Hyomental distance. Based on measured hyomental distance, size of pLMA will be chosen.The procedure takes approximately 5- 10 minutes per patient |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18 to 70 years old.
Either sex
American Society of Anesthesiologists (ASA) physical status I – II
Patients undergoing elective surgery under general anesthesia. |
|
| ExclusionCriteria |
| Details |
Patiens with
Refusal to participate.
Weight less than 30kg or more than 75kg, pregnant women..
High risk of regurgitation or aspiration (large hiatal hernia, history of gastroesophageal
reflux disease (GERD), or uncontrolled diabetes mellitus).
Abnormal pharynx or anatomy
Anticipated difficult airway
Limited neck mobility
Coagulation disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the first attempt success rate of optimal pLMA placement between both the methods |
Intraoperatively at the time of first pLMA insertion attempt immediately after induction of anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate oropharyngeal leak pressure
To asses the ease of pLMA insertion
To document the incidence of pharyngolaryngeal morbidity |
Oropharyngeal leak pressure will be measured Intraoperatively immediately after pLMA insertion
Ease of pLMA insertion will be assessed Intraoperatively at the time of insertion
Pharyngolaryngeal morbidity will be assessed postoperatively within 24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
23/02/2026 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 Randomised Clinical trial aims to compare USG guided hyomental distance measurement with the conventional weight based method for selecting size of pLMA.Eligible patients will be randomised in two groups.The primary outcome will be successful device placement, and airway seal, while secondary outcomes will include ease of insertion, number of attempts and airway related complications. The study seeks to assess whether USG guided measurement offers an advantage over the traditional weight based approach. |