| CTRI Number |
CTRI/2025/12/098810 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing three methods of inserting a breathing mask to see which works best in adult patients |
|
Scientific Title of Study
|
Comparison of standard technique versus 90° rotation technique versus Endotracheal Tube aided insertion of LMA Flexible™ in adult patients: a randomized controlled trial. |
| 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 Anish Shrikant Vaidya |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal nehru medical college |
| Address |
Department of anaesthesia, Prabhakar Kore hospital, NH Service Road, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8971798480 |
| Fax |
|
| Email |
anish20397@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Mane |
| Designation |
Professor, head of department |
| Affiliation |
Jawaharlal nehru medical college |
| Address |
Department of anaesthesia, Prabhakar Kore hospital, NH Service Road, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590 001
India |
| Phone |
9844131062 |
| Fax |
|
| Email |
drrajeshmane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Mane |
| Designation |
Professor, head of department |
| Affiliation |
Jawaharlal nehru medical college |
| Address |
Department of anaesthesia, Prabhakar Kore hospital, NH Service Road, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590 001
India |
| Phone |
9844131062 |
| Fax |
|
| Email |
drrajeshmane@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia, Prabhakar Kore hospital, NH Service Road, Nehru Nagar, Belagavi, Karnataka 590010 India |
|
|
Primary Sponsor
|
| Name |
Dr Anish Shrikant Vaidya |
| Address |
Department of anaesthesia, Prabhakar Kore hospital, NH Service Road, Nehru Nagar, Belagavi, Karnataka 590010 India |
| Type of Sponsor |
Other [self] |
|
|
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 Anish Shrikant Vaidya |
Prabhakar Kore hospital, Jawarharlal Nehru Medical college |
Department of anaesthesia, Prabhakar Kore hospital, NH Service Road, Nehru Nagar, Belagavi, Karnataka 590010 India
Belgaum
KARNATAKA |
08971798480
anish20397@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC 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 |
| Comparator Agent |
90° rotation technique for LMA Flexible™ |
LMA Flexible™ inserted with cuff deflated; after entry into the mouth, the device is rotated 90° anticlockwise and advanced along the right side of the tongue until resistance is felt. Cuff inflated a The total duration of the insertion procedure is approximately 30–60 seconds after placement. |
| Comparator Agent |
Endotracheal tube–aided insertion of LMA Flexible™ |
A 5-mm internal diameter endotracheal tube cut to 24 cm is inserted into the LMA Flexible™ to provide rigidity. The assembly is inserted until resistance is felt, after which the ETT is removed and the cuff is inflated. The total duration of the insertion procedure is approximately 30–60 seconds |
| Intervention |
Standard insertion of LMA Flexible™ |
Insertion of LMA Flexible™ using the standard technique with fully deflated cuff, introduced along the palatopharyngeal curve until resistance is felt. Cuff inflated after placement. The total duration of the insertion procedure is approximately 30–60 seconds |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged between 18 years to 65 years with ASA grade one and two |
|
| ExclusionCriteria |
| Details |
Patients with difficult airway
Patients with mouth opening of less than 2.5cm
Patients with limited extension of neck
Patients with recent sore throat
Patients with recent gastro oesophageal reflex disease.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • To compare the three different insertion techniques for LMA Flexible™—standard, 90° rotation, and endotracheal tube aided insertion in terms of ease of insertion. |
one minute after induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•To compare the first-time success of insertion & time for insertion.
|
one minute after induction |
|
|
Target Sample Size
|
Total Sample Size="99"
Sample Size from India="99"
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 |
|
Date of First Enrollment (India)
|
20/12/2025 |
| 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="2"
Months="0"
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 randomized controlled trial compares three techniques for inserting the LMA Flexible™ in adult patients undergoing elective surgery under general anaesthesia: the standard method, the 90° rotation technique, and endotracheal tube-aided insertion. Because the flexible shaft of the LMA Flexible™ can make placement difficult, alternative methods may improve ease and success of insertion. Ninety-nine ASA I–II adults will be randomly assigned to one of the three groups. The primary outcome is ease of insertion; secondary outcomes include first-attempt success and insertion time. The study aims to identify the technique that provides the most effective, safe, and reliable insertion of the LMA Flexible™. |