| CTRI Number |
CTRI/2025/10/095971 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of ultrasound to measure tongue thickness in patients undergoing surgery under anaesthesia to predict difficulty in inserting a breathing tube |
|
Scientific Title of Study
|
Ultrasound-Guided Tongue Thickness Measurement for Predicting Difficult Tracheal Intubation: A Cross-Sectional Analysis |
| Trial Acronym |
UGTT-DTI Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Seetharaman M |
| Designation |
Post graduate student |
| Affiliation |
PSG IMSR |
| Address |
Department of Anaesthesiology,
PSG IMSR Hospital,
Post Box 1674 Off,
Avinashi Road,
Peelamedu,
Coimbatore.
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9894342570 |
| Fax |
|
| Email |
seetharamanmohan7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Seetharaman M |
| Designation |
Post graduate student |
| Affiliation |
PSG IMSR |
| Address |
Department of Anaesthesiology,
PSG IMSR Hospital,
Post Box 1674 Off,
Avinashi Road,
Peelamedu,
Coimbatore.
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9894342570 |
| Fax |
|
| Email |
seetharamanmohan7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Seetharaman M |
| Designation |
Post graduate student |
| Affiliation |
PSG IMSR |
| Address |
Department of Anaesthesiology,
PSG IMSR Hospital,
Post Box 1674 Off,
Avinashi Road,
Peelamedu,
Coimbatore.
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9894342570 |
| Fax |
|
| Email |
seetharamanmohan7@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SEETHARAMAN M |
| Address |
Post Box 1674 Off
Avinashi Road
Peelamedu
Coimbatore |
| 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 PRASANTH KUMAR M S |
PSG IMSR Hospital |
Operation Theatre Complex,
Department of Anaesthesiology,
Department of Anaesthesiology,
Avinashi Road,
Peelamedu,
Coimbatore.
Coimbatore
TAMIL NADU |
9344807280
drprasanth1979@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee PSG Institute of Medical Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z018||Encounter for other specified special examinations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I and II
Patients undergoing Elective surgery under general anaesthesia with endotracheal intubation
BMI 18.5to 40 kg per meter squared |
|
| ExclusionCriteria |
| Details |
Patients with Thyroid/neck swelling
Cervical spine fracture
Facial/maxillofacial fracture or abnormality
Upper airway tumours
Inter-incisor distance less than3 cm
Pregnant patients
Previous history of difficult intubation
Completely edentulous patients
Syndrome patients
Tobacco chewers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accuracy of ultrasound-guided tongue thickness measurement in predicting difficult tracheal intubation (measured against Cormack–Lehane grade and number of intubation attempt) |
At the time of induction of anaesthesia and direct laryngoscopy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation between ultrasound-measured tongue thickness and Modified Mallampati score.
|
Preoperative airway assessment (before surgery) |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
27/10/2025 |
| 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="0"
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
|
This is a cross-sectional observational study in adult patients undergoing elective surgeries under general anaesthesia. The study aims to evaluate whether ultrasound measurement of tongue thickness can predict difficulty in placing a breathing tube (endotracheal intubation). Conventional bedside airway tests, such as the Modified Mallampati score, are often subjective and have limited accuracy. Ultrasound is a non-invasive, quick, and reproducible method for pre-operative airway assessment. In this study, tongue thickness will be measured pre-operatively using a linear ultrasound probe, and findings will be compared with intubation difficulty assessed during anaesthesia induction using the Cormack–Lehane grading and number of intubation attempts. The primary outcome is to determine the diagnostic accuracy of tongue thickness in predicting difficult intubation. Secondary outcomes include correlation with Modified Mallampati score and prediction of difficult mask ventilation. The study will be conducted in 110 patients at PSG Institute of Medical Sciences and Research over one year. |