| CTRI Number |
CTRI/2026/01/101472 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Using ultrasound for finding out difficulty in seeing vocal cord by measuring tongue size skin to epiglottis distance and neck distance a forward looking study |
|
Scientific Title of Study
|
Airway Ultrasound for Prediction of difficult laryngoscopy using tongue thickness skin to epiglottis distance and hyomental distance a prospective 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 |
V Veer partha sarathi |
| Designation |
1st year post graduate department of anaesthesiology |
| Affiliation |
Ballari medical College and research centre |
| Address |
Department Of anaesthesia
major ot complex
ballari medical College and Research centre
vijaynagar Cantonment Ballari Karnataka Department Of anaesthesia
major ot complex
Ballari medical College and Research centre
Vijaynagar Cantonment Ballari Karnataka Bellary KARNATAKA 583104 India |
| Phone |
8608239055 |
| Fax |
|
| Email |
happyjohncv5055@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jyothsna |
| Designation |
Professor department of anaesthesiology |
| Affiliation |
Ballari medical College and research centre |
| Address |
Department Of Anaesthesia
major ot complex
ballari medical College and Research centre
vijaynagar Cantonment Ballari Karnataka Department Of Anaesthesia
major ot complex
ballari medical College and Research centre
vijaynagar Cantonment Ballari Karnataka Bellary KARNATAKA 583104 India |
| Phone |
9900055996 |
| Fax |
|
| Email |
jyothsnabk@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Jyothsna |
| Designation |
Professor department of anaesthesiology |
| Affiliation |
Ballari medical College and research centre |
| Address |
Department Of Anaesthesia
major ot complex
ballari medical College and research centre
vijaynagar Cantonment Ballari Karnataka Department Of Anaesthesia
major ot complex
ballari medical College and research centre
vijaynagar Cantonment Ballari Karnataka Bellary KARNATAKA 583104 India |
| Phone |
9900055996 |
| Fax |
|
| Email |
jyothsnabk@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ballari medical College and Research centre |
| Address |
Department Of anaesthesia
major ot complex
Ballari medical College and Research centre
Vijaynagar Cantonment Ballari Karnataka |
| 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 Veera partha sarathi |
Ballari medical college and research Centre |
Department of anesthesia OT complex BMCRC cantonment ballari Bellary KARNATAKA |
8608239055
happyjohncv5055@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee ballari medical College and research centre ballari |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: H713||Diffuse cholesteatosis, (2) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, (3) ICD-10 Condition: H739||Unspecified disorder of tympanic membrane, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 18 to 65 years
ASA Physical Status I to III
Scheduled for surgeries under general anesthesia requiring orotracheal intubation
Normal mouth opening and neck mobility |
|
| ExclusionCriteria |
| Details |
Facial deformity Tumors Prior airway surgery
Morbid obesity BMI more than 40 kg m²
Pregnant women
Neck pathology swelling masses cervical spine deformity
Cervical spine instability
Refusal to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation of three ultrasound-based predictor tongue thickness skin-to-epiglottis distance and hyomental distance together with difficult airway |
Preoperative 30 minutes before induction
Intraoperative 2 mins after induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of each of the individual ultrasound parameters or combination of two parameters with difficult laryngoscopy |
Preoperative 30 mins before induction of patient
Intraoperative 2 mins after induction of patient |
Optimal cut-off values for each ultrasound parameter associated with difficult laryngoscopy.
|
Preoperative 30 mins before induction of patient
Intraoperative 2 mins after induction of patient |
| Comparison with standard clinical predictors Mallampati classification thyromental distance in terms of predictive performance |
Preoperative before day of surgery
Intraoperative 2 mins after induction |
| Incidence of difficult laryngoscopy defined by Cormack Lehane grades during direct laryngoscopy in correlation with preoperative ultrasound measurements of tongue thickness skin to epiglottis distance & hyomental distance |
Preoperative 30 mins before induction of patient
Intraoperative 2 mins after induction of patient |
|
|
Target Sample Size
|
Total Sample Size="526" Sample Size from India="526"
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)
|
01/02/2026 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [happyjohncv5055@gmail.com].
- For how long will this data be available start date provided 01-08-2025 and end date provided 01-08-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Title Airway Ultrasound for Prediction of Difficult Laryngoscopy Using Tongue Thickness Skin to Epiglottis Distance and Hyomental Distance A Prospective Observational Study
Background and Need for Study
Difficult airway during anesthesia increases the risk of complications.
Traditional assessment methods like Mallampati score and thyromental distance are not very accurate.
Ultrasound provides a safe and real-time method to examine the airway.
There is a need to validate ultrasound-based measurements for predicting difficult laryngoscopy
Objectives
Primary Objective
To assess the relationship between ultrasound measurements and difficult laryngoscopy based on Cormack Lehane grading
Secondary Objectives
To compare each ultrasound parameter individually and in combination
To find the best cut off values for prediction
To compare ultrasound results with traditional clinical airway tests
Methodology
Study Type Prospective observational clinical study
Duration One year and six months from May 2025 to November 2026
Sample Size 526 adult patients aged 18 to 65 undergoing elective surgery under general anesthesia
Inclusion ASA Class I to III, normal mouth opening and neck mobility
Exclusion Facial deformity, neck pathology, morbid obesity, pregnancy, previous airway surgery
Preoperative ultrasound measurements include
Tongue thickness
Skin to epiglottis distance
Hyomental distance in neutral and extended positions
Laryngoscopy performed by a separate anesthesiologist who is unaware of the ultrasound findings
Analysis
Statistical tools include regression analysis and ROC curve
Main outcome is correlation of ultrasound findings with difficulty in laryngoscopy
Additional outcomes include accuracy of each parameter and comparison with clinical scores
Importance
If successful this method can help in better preparation for airway management and improve patient safety before anesthesia |