| CTRI Number |
CTRI/2025/08/092919 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Using Ultrasound to Predict Unexpected Difficult Airways Before Surgery |
|
Scientific Title of Study
|
Preoperative ultrasonographic measurements of tongue thickness, tongue thickness-thyromental distance ratio and skin to epiglottis distance in predicting unanticipated difficult airway. A prospective comparative 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 |
Dr Sanjana S |
| Designation |
Post Graduate in Department of Anaesthesia |
| Affiliation |
SDM college of medical sciences and hospital manjushree nagar , Dharwad |
| Address |
DEPARTRMENT OF ANAESTHESIOLOGY, SDMCMSH, MANJUSHREE NAGAR, SATTUR, DHARWAD- 570009
Dharwad
KARNATAKA
570009
India |
| Phone |
7022370023 |
| Fax |
|
| Email |
sanjanasridhar99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pavan Dhulkhed |
| Designation |
Associate Professor |
| Affiliation |
SDM college of medical sciences and hospital manjushree nagar , Dharwad |
| Address |
Department of Anaesthesia SDM College of medical sciences and hospital sattur dharwad
Dharwad
KARNATAKA
570009
India |
| Phone |
8150885678 |
| Fax |
|
| Email |
pavandhulkhed1984@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pavan Dhulkhed |
| Designation |
Associate professor |
| Affiliation |
SDM college of medical sciences and hospital manjushree nagar , Dharwad |
| Address |
Department of Anaesthesia SDM College of medical sciences and hospital sattur dharwad
Dharwad
KARNATAKA
570009
India |
| Phone |
8150885678 |
| Fax |
|
| Email |
pavandhulkhed1984@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of medical science and hospital sattur Dharwad-Karnataka 580009 |
|
|
Primary Sponsor
|
| Name |
SDM College of medical sciences and hospital sattur dharwad Karnataka |
| Address |
SDM College of medical sciences and hospital sattur dharwad 580009 |
| 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 |
| Dr Sanjana s |
Main OT complex SDM college of medical sciences and hospital manjushree nagar , Dharwad |
SDM College of medical sciences and hospital sattur dharwad Karnataka 580009
Dharwad
KARNATAKA |
702237003
sanjanasridhar99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The IEC-SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing elective surgeries under general anesthesia.
2. Patients willing to participate in study
3. ASA physical status 1,2
4. Patient aged 18-60 years |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare ultrasonography measured clinical airway indices across easy and difficult groups. |
Preoperative assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Computation of diagnostic accuracy with appropriate cut-offs of ultrasonography measured indices in predicting difficult laryngoscopy. |
Preoperative assessment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/08/2025 |
| 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="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 - NO
|
|
Brief Summary
|
This is a prospective observational study conducted from August 2025 to February 15 2026 in a tertiary care teaching hospital, involving 60 patients undergoing elective surgeries under general anesthesia requiring endotracheal intubation. The study aims to assess the correlation between preoperative upper airway ultrasound measurements and the difficulty of laryngoscopy. Preoperative evaluation includes airway examination (such as thyromental distance), administration of pantoprazole, and ultrasound assessment using curvilinear and linear probes to measure tongue thickness (TT) and distance from skin to epiglottis (DSE). During surgery, direct laryngoscopy will be performed, and the Cormack-Lehane (CL) grade will be documented without external laryngeal manipulation. Laryngoscopy is classified as easy (CL I, II) or difficult (CL III, IV), and the need for adjuncts like bougie or stylet will also be noted. The study aims to identify ultrasound-based predictors of difficult airway management. |