| CTRI Number |
CTRI/2025/09/095443 [Registered on: 29/09/2025] Trial Registered Prospectively |
| Last Modified On: |
27/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Operator Positions For Proseal Laryngeal Mask Airway (PLMA) Insertion:A Randomized Clinical Study. |
|
Scientific Title of Study
|
Comparative Evaluation of Two Different Operator Positions on the Insertion Characteristics of Proseal Laryngeal Mask Airway in Patients Undergoing Elective Surgery under General Anaesthesia A Randomized Clinical 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 |
Hemlata Jangra |
| Designation |
POST GRADUATE Student Department of Anesthesia |
| Affiliation |
ESIC MEDICAL COLLEGE ,FARIDABAD |
| Address |
Department of Anaesthesia, OT Complex 3rd Floor, Esic Medical College and Hospital,NIT3 Faridabad 121001,Haryana ,India
Faridabad
HARYANA
121001
India |
| Phone |
09812662457 |
| Fax |
|
| Email |
hemlatajangra96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mamta kumari |
| Designation |
Associate Professor ,Department Of Anaesthesia |
| Affiliation |
ESIC MEDICAL COLLEGE ,FARIDABAD |
| Address |
Department Of Anaesthesia,Ot complex 3rd floor,Esic Medical College And Hospital ,NIT3 Faridabad 121001,Haryana ,India
Faridabad
HARYANA
121001
India |
| Phone |
07042007154 |
| Fax |
|
| Email |
dr.mamta85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mamta kumari |
| Designation |
Associate Professor ,Department Of Anaesthesia |
| Affiliation |
ESIC MEDICAL COLLEGE ,FARIDABAD |
| Address |
Department Of Anaesthesia,Ot complex 3rd floor,Esic Medical College And Hospital ,NIT3 Faridabad 121001,Haryana ,India
Faridabad
HARYANA
121001
India |
| Phone |
07042007154 |
| Fax |
|
| Email |
dr.mamta85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Depatment Of Anaesthesia,Ot complex 3rd floor,Esic Medical College And Hospital,NIT3,Faridabad,121001,Haryana ,India |
|
|
Primary Sponsor
|
| Name |
Hemlata |
| Address |
Depatment Of Anaesthesia,Ot complex 3rd floor,Esic Medical College And Hospital,NIT3,Faridabad,121001, Haryana ,India
|
| Type of Sponsor |
Other [No] |
|
|
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 Hemlata |
Esic Medical College And Hospital |
Department of Anaesthesia,OT 3rd Floor Complex,Esic Medical College And Hospital,NIT3,Faridabad,Haryana,121001,India
Faridabad
HARYANA |
09812662457
hemlatajangra96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group F (Front end ) |
lma insertion from front end |
| Intervention |
Group H(Head end) |
lma insertion from head end |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists (ASA) physical Status I and II
Modified Mallampati grading I and II
Body Mass Index (BMI) of 18-30 kg/m2 |
|
| ExclusionCriteria |
| Details |
Patients with an anticipated difficult airway
Patients at risk of aspiration |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
PRIMARY OBJECTIVE
To evaluate and compare the time taken for successful insertion of PLMA in two different operator positions in patients undergoing elective surgery under general anaesthesia.
|
15-20 seconds
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SECONDARY OBJECTIVES
To evaluate and compare:
1.First attempt success rate
2.Overall success rate (maximum 3 attempts)
3.Ease of insertion
4.Measurement of oropharyngeal leak pressure (OPLP)
5.Fibre Optic Bronchoscopy guided Glottic View grading through PLMA for proper placement
6.Incidence of pharyngolaryngeal morbidity
blood stain over LMA,
postoperative sore throat,
postoperative pain on swallowing
after the recovery from anaesthesia.
|
15-20 seconds |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
08/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/10/2025 |
| 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 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
|
The study is a randomized clinical trial comparing two different operator positions for ProSeal Laryngeal Mask Airway (PLMA) insertion in patients undergoing elective surgery under general anesthesia.
Key Details- Title Comparative evaluation of two different operator positions on the insertion characteristics of ProSeal LMA in patients undergoing elective surgery under general anesthesia. Patients: ASA I and II, modified Mallampati grading I and II, BMI 18-25 kg/m2. Exclusions: Patients with anticipated difficult airway or at risk of aspiration. Sample SizeN 60 patients. Groups: Randomized into Group H (PLMA insertion from head end) and Group F (PLMA insertion from front). Primary Objective Compare time taken for successful PLMA insertion in two operator positions. Secondary Objectives Evaluate and compare first attempt success rate, overall success rate, ease of insertion, oropharyngeal leak pressure, fiberoptic view grading, and pharyngolaryngeal morbidity.
CTRI Registration Considerations- Trial Design Randomized clinical trial. - Intervention Comparison of PLMA insertion techniques. - Outcome Measures Time for insertion, success rates, ease, complications.
|