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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  
Nil 
 
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  
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 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  
Status 
Not Applicable 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. 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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [happyjohncv5055@gmail.com].

  6. 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.

  7. 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
 
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