FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/03/105161 [Registered on: 02/03/2026] Trial Registered Prospectively
Last Modified On: 28/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective observational study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   A study comparing two ways to insert a breathing airway device(Laryngeal mask airway) 
Scientific Title of Study   Analysis of laryngeal mask airway; A comparison between the standard method with 30 degree curved tongue depressor aided technique-An observational 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  DRSRIDEVI N 
Designation  Post graduate student 
Affiliation  Institute of Anaesthesiology, Madurai medical college. 
Address  No.121,Institute of Anaesthesiology, Anaesthesia division, Government Rajaji Hospital and Madurai Medical College, Madurai-625020.

Namakkal
TAMIL NADU
638183
India 
Phone  7530011245  
Fax    
Email  sri683347@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrNRajanalini MD DGO 
Designation  Professor 
Affiliation  Institute of Anaesthesiology, Maurai medical college 
Address  Institute of Anaesthesiology, Maurai medical college, Madurai-625020

Madurai
TAMIL NADU
625020
India 
Phone  8056057566  
Fax    
Email  rajanalinimmc@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrNRajanalini MD DGO 
Designation  Professor 
Affiliation  Institute of Anaesthesiology, Maurai medical college 
Address  Institute of Anaesthesiology, Maurai medical college, Madurai-625020

Madurai
TAMIL NADU
625020
India 
Phone  8056057566  
Fax    
Email  rajanalinimmc@gmail.com  
 
Source of Monetary or Material Support  
Institute of Anaesthesiology,Government Rajaji hospital & Madurai medical college,Madurai-625020 
 
Primary Sponsor  
Name  Dr Sridevi N 
Address  Institute of Anaesthesiology,Government Rajaji hospital & Madurai medical college,Madurai-625020 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sridevi N  Government Rajaji Hospitals& Madurai Medical College,Madurai  Fifth floor,JICA Building,Government Rajaji Hospital & Madurai medical college, Madurai,TAMILNADU
Madurai
TAMIL NADU 		 7530011245

sri683347@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee,Government Rajaji Hospitals&Madurai medical college,Madurai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D24||Benign neoplasm of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  30 degree curved tongue depressor aided LMA insertion technique  A 30 degree curved tongue depressor is inserted in midline to lift the tongue anteriorly and increase oral space,the LMA is then advanced along the hard palate into the hypopharynx under guidance of the depressor, followed by cuff inflation and confirmation of ventilation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  ASA1&ASA2 PATIENTS THOSE WHO ARE WILLING TO GIVE INFORMED WRITTEN CONSENT 
 
ExclusionCriteria 
Details  Refusal to participate
Mouth opening less than 2.5 cm
Risk of aspiration (e.g., GERD, hiatal hernia, full stomach)
Pregnancy
BMI more than 30 kg/m²
Known lung disease
Surgery in non-supine position
Anticipated difficult airway (Mallampati III/IV, limited neck extension, limited jaw protrusion, history of difficult intubation or snoring)
Anatomical abnormalities of the cervical spine or airway 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
First-attempt success rate of LMA insertion
 		 During LMA insertion after induction of anaesthesia (within 60 seconds of first attempt) 
 
Secondary Outcome  
Outcome  TimePoints 
Second-attempt success rate  Immediately during LMA insertion(within 60 seconds of second attempt) 
Fiberoptic position grading  Immediately after successful LMA placement 
Oropharyngeal leak pressure  Immediately after successful LMA placement 
Incidence of complications  Bleeding (at the time of LMA removal)
Sorethroat (In recovery room within 1 hour post extubation)
Dysphagia,dysphonia (within 1 hour post extubation) 
 
Target Sample Size   Total Sample Size="138"
Sample Size from India="138" 
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)   20/04/2026 
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)   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 observational  study evaluates whether a 30° curved tongue depressor–aided technique improves the success of laryngeal mask airway (LMA) insertion compared to the standard index finger method in adult patients under general anesthesia. The study primarily assesses first-attempt success rate, along with insertion time,  leak pressure, and postoperative complications such as sore throat and bleeding. 
Close