| 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
|
|
|
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
|
|
|
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
. |