| CTRI Number |
CTRI/2025/01/079147 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
ASSESSMENT BETWEEN MEASUREMENT OF JAW MOVEMENT BY ULTRASOUND GUIDED & CONVENTIONAL TECHNIQUES IN PREDICTING DIFFICULTY IN INTUBATION |
|
Scientific Title of Study
|
CLINICAL ASSESSMENT BETWEEN MEASUREMENT OF MANDIBULAR CONDYLAR MOBILITY (USG GUIDED) VERSUS MAXIMUM CONDYLE - TRAGUS DISTANCE IN PREDICTING DIFFICULT LARYNGOSCOPY |
| 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 Varsha M |
| Designation |
Junior Resident in Department of Anaesthesiology |
| Affiliation |
Gandhi Medical College, Bhopal |
| Address |
Operation Theatre, 2nd floor, Department of Anaesthesiology, Hamidia hospital, Gandhi Medical College, Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
7356669628 |
| Fax |
|
| Email |
varshamanal96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surendra K Raikwar |
| Designation |
Professor |
| Affiliation |
Gandhi Medical College, Bhopal |
| Address |
Operation Theatre, 2nd floor, Department of Anaesthesiology, Hamidia hospital, Gandhi Medical College, Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9406533300 |
| Fax |
|
| Email |
drskraikwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neelesh Nema |
| Designation |
Assistant Professor |
| Affiliation |
Gandhi Medical College, Bhopal |
| Address |
Operation Theatre, 2nd floor, Department of Anaesthesiology, Hamidia hospital, Gandhi Medical College, Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
09893427372 |
| Fax |
|
| Email |
neeleshnema@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Gandhi Medical College, Bhopal, Madhya Pradesh, India 462001 |
|
|
Primary Sponsor
|
| Name |
Gandhi Medical College |
| Address |
Gandhi Medical College, Bhopal, Madhya Pradesh, 462001 |
| Type of Sponsor |
Government 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 Varsha M |
Gandhi Medical College, Bhopal |
Operation Theatre, 2nd floor, Department of Anaesthesiology, Hamidia hospital, Gandhi Medical College, Bhopal
Bhopal
MADHYA PRADESH |
07356669628
varshamanal96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Gandhi Medical College, Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
persons who are undergoing surgeries under general anaesthesia at Gandhi Medical College Bhopal |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-65 years
2. ASA Grade I & II
3. Patients scheduled for tracheal intubation under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1 Patients with maxillofacial trauma or malformation
2 Patients with maxillofacial oral or tongue cancer
3 Patients with laryngeal and tracheal neck tumor compression
4 Patients with BMI more than 30
5 Patients with history of previous difficult intubations
6 Uncooperative patients
7 Patient with asymmetric movement of TMJ joint
8 Bearded patients
9 Patients with age less than 18 years & more than 65 years
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 USG guided measurement of mandibular condylar mobility using high
frequency linear array ultrasound probe
2 Conventional measurement of Maximum Condyle Tragus distance measured
using examiners finger
3 Cormack-Lehane grading will be measured during laryngoscopy without
external manipulation |
Before induction till during the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Inter Incisor Gap measurement
2 Upper Lip Bite Test grading
3 Mandibular Protrusion Distance grading
|
Before induction till during the procedure |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
31/01/2025 |
| 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="1"
Days="10" |
|
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
|
Pre operative airway assessment is a crucial step in airway management. There is no single parameter which has maximum accuracy in this perspective. There are many studies in this field to explore different parameters for this purpose. Using USG measurments particularly to measure mandibular condylar mobility adds a sophisticated dimension to predicting laryngoscopy. By comparing the efficacy of USG guided measurements with conventional parameters like Maximum condyle tragus distance, Upper Lip Bite Test, Inter Incisor Gap and Mandibular Protrusion Distance, this study helps to find the most reliable indiactors for anticipating a difficult airway. This approach could potentially improve preoperative assessmnet, making airway management safer and more efficient. |