| CTRI Number |
CTRI/2025/12/099155 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
14/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Finding tongue volume using ultrasound |
|
Scientific Title of Study
|
Tongue volume as a predictor of difficult airway- an ultrasonography 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 |
Geethika Reddy Jaggavarapu |
| Designation |
Junior Resident |
| Affiliation |
KS Hegde Medical Academy, Deralakatte |
| Address |
Department of Anaesthesiology KS Hegde Medical Academy Deralakatte Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8179473909 |
| Fax |
|
| Email |
geethikajaggavarapu9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siri Kandavar |
| Designation |
Associate Professor |
| Affiliation |
KS Hegde Medical Academy |
| Address |
Department of Anaesthesiology KS Hegde Academy Deralakatte Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9739868002 |
| Fax |
|
| Email |
sirikandavar16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siri Kandavar |
| Designation |
Associate Professor |
| Affiliation |
KS Hegde Medical Academy |
| Address |
Department of Anaesthesiology KS Hegde Academy Deralakatte Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9739868002 |
| Fax |
|
| Email |
sirikandavar16@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Geethika Reddy Jaggavarapu |
| Address |
Department of Anaesthesiology
KS Hegde Medical Academy Deralakatte Mangalore 575018 |
| Type of Sponsor |
Private 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 |
| Geethika Reddy Jaggavarapu |
KS HEGDE MEDICAL ACADEMY |
Department of Anaesthesiology 1st floor KS HEGDE MEDICAL ACADEMY
deralakatte, mangaluru-575018
Dakshina Kannada
KARNATAKA |
8179473909
geethikajaggavarapu9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KS Hegde Medical Academy Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
nil |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective procedures under general anaesthesia of 18years - 50 years of age |
|
| ExclusionCriteria |
| Details |
Patients who dropped out of study
Modified Anaesthesia protocol or cancellation of tracheal intubation for a non difficult airway reason
Obvious anatomical deformity, trauma, or tumour of face
Obvious difficulty airway or known case of difficult airway
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prediction value of tongue volume for difficult airway |
USG measurement of tongue volume on day of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="256"
Sample Size from India="256"
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)
|
09/01/2026 |
| 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="2"
Months="0"
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 is a study for predicting difficult airway calculating tongue volume via USG(after PAC ultrasound guided measurement of tongue volume will be done on the day of surgery) 1. Routine airway assessment will be done 2.HANS criteria and MODIFIED CL GRADE will be noted |