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CTRI Number  CTRI/2025/11/096841 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 31/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A syudy comparing different methods used to predict difficult airway during anaesthesia in adults  
Scientific Title of Study   A comparative study to evaluate different airway tests used to determine difficult intubation in adult patients in SMS medical college jaipur 
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 Rajeev Sharma 
Designation  Senior Professor  
Affiliation  SMS Medical college jaipur rajasthan 
Address  2nd floor dhanvantari building plastic operation theatre department of anaesthesia sms medical college jaipur rajasthan
2nd floor dhanvantari building plastic operation theatre department of anaesthesia sms medical college jaipur rajasthan
Jaipur
RAJASTHAN
302004
India 
Phone  9829088926  
Fax    
Email  Sharma.rajeev0911@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajeev Sharma 
Designation  Senior Professor  
Affiliation  SMS Medical college jaipur rajasthan 
Address  2nd floor dhanvantari building plastic operation theatre department of anaesthesia sms medical college jaipur rajasthan
2nd floor dhanvantari building plastic operation theatre department of anaesthesia sms medical college jaipur rajasthan
Jaipur
RAJASTHAN
302004
India 
Phone  9829088926  
Fax    
Email  Sharma.rajeev0911@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deepika 
Designation  Resident doctor  
Affiliation  SMS medical college and hospital jaipur 
Address  Department of anaesthesia Sms medical college jaipur rajasthan
Department of anaesthesia Sms medical college jaipur rajasthan
Jaipur
RAJASTHAN
302004
India 
Phone  9991167456  
Fax    
Email  Drmanderna22@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesia sms medical college amd hospital jaipur rajasthan 
 
Primary Sponsor  
Name  SMS Medical college and hospital jaipur rajasthan 
Address  Department of anaesthesia sms medical college amd hospital jaipur rajasthan 
Type of Sponsor  Government medical college 
 
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 Rajeev sharma  sms medical college jaipir  Plastic surgery operation theatre 2nd floor dhanvantari building sms medical college jaipur
Jaipur
RAJASTHAN 
9829088926

Sharma.rajeev0911@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of ethics committee sms medical college and hospital jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adult patient undergoing intubation
Age between 18 to 60 years
Ability to give consent
Able to comply with test 
 
ExclusionCriteria 
Details  Patient not giving consent
Emergemcy cases
Cognitive impairment
Recent oral surgery
Pregnancy
Neck mass
Cervical spine injury
Anticipated difficult intubation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Sensitivity and specificity of thyromental distance test,sternomental distance, modified mallampati test with tongue protusion and without tongue protrusion ,mandible protrusion test, interincisor gap in relation to cormack lehane grading  During preanaesthestic check up and during laryngoscopy  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="83"
Sample Size from India="83" 
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)   25/11/2025 
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="0"
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   Inadequate maintenance of a patient’s airway represents a major cause of anaesthesia related morbidity and mortality. The 
prevalence of difficult laryngoscopic intubation is reported to range from 1.5 to 20% cases 
Unanticipated difficult airway remains a major concern for anaesthesiologists due to serious consequences of failed 
endotracheal intubation. The identification of patients with difficult airways is crucial during preoperative evaluations.
A variety of tests are used to evaluate potentially difficult airways in advance of the procedure . However, it is not clear 
which test has best sensitivity to predict difficult airway. 
   Commonly used tests are Modified Mallampati test with tongue protrusion (MMT-TP), modified mallampati test without 
tongue protrusion (MMT-NTP), inter incisor gap (IIG), thyromental distance (TMD), sternomental distance (SMD), 
mandible protrusion test (MPT) for prediction of difficult intubation relative to the Cormack Lehane grading for   
Laryngoscopic view.
Modified Mallampati Test (MMT) is the oldest bedside test that predicts difficult intubation by assessing mouth opening and 
visibility of pharyngeal structure.
For predicting difficult intubations, the mandible protrusion test is well established and relatively simple grading system.
Thyromental distance is measured along a straight line from the thyroid cartilage prominence to the lower border of the 
mandibular mentum with full head extension and mouth closed. It is a common method to predict difficult airways. The
 smaller the TMD is, the greater the probability of a difficult airway Sternomental distance (SMD is an indicator of head 
and neck mobility . IIG is a major single predictor for difficult airways. It reflects craniocervical extension, which is 
restricted in cervical spondylosis patients

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