| CTRI Number |
CTRI/2025/01/079738 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison Of Airway Predictor Parameter As A Predictor Of Difficult Laryngoscopy In Obese Vs NON-Obese |
|
Scientific Title of Study
|
Ratio Of Height To Thyromental Distance Vs Ratio Of Neck Circumference to Thyromental Distance as a Predictor of Difficult Laryngoscopy in Obese VS NON-OBESE -An Observational Comparative 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 |
SAURAV KUMAR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
AIIMS DEOGHAR |
| Address |
Department of Anaesthesiology and Critical Care,AIIMS DEOGHAR
AIIMS DEOGHAR
Deoghar
JHARKHAND
814152
India |
| Phone |
9241939504 |
| Fax |
|
| Email |
thesauravgupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sanjay Kumar |
| Designation |
Additional professor |
| Affiliation |
AIIMS DEOGHAR |
| Address |
Department of Anaesthesiology and Critical Care, AIIMS DEOGHAR
AIIMS DEOGHAR
Deoghar
JHARKHAND
814152
India |
| Phone |
9241939504 |
| Fax |
|
| Email |
drsanjayaiims2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SAURAV KUMAR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
AIIMS DEOGHAR |
| Address |
Department of Anaesthesiology and Critical Care,AIIMS DEOGHAR
AIIMS DEOGHAR
JHARKHAND
814152
India |
| Phone |
9241939504 |
| Fax |
|
| Email |
thesauravgupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology and critical Care,AIIMS DEOGHAR, Deoghar, Jharkhand, India pincode-814152 |
|
|
Primary Sponsor
|
| Name |
AIIMS DEOGHAR |
| Address |
DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE, AIIMS Deoghar, Deoghar, jharkhand, INDIA pin-814152 |
| 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 |
| SAURAV KUMAR |
AIIMS DEOGHAR |
PSE and OT Complex
Deoghar
JHARKHAND |
9241939504
thesauravgupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS DEOGHAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA 1 and 2 classified individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
BMI: 18.5- 40 kg/m2.
Elective surgeries.
ASA PS- I to II.
|
|
| ExclusionCriteria |
| Details |
Patient’s refusal.
Patients with inadequate mouth. opening, edentulous.
Patient with external deformity in neck region.
Patient with cervical spine pathology.
Patient who will not require endotracheal intubation.
Pregnant patient.
• Patient with known case of airway disease.
• Patient requiring rapid sequence intubation.
• Patient with craniofacial deformity.
• ASA PS III |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare which one among RHTDM Vs NC/TMD is a better predictor of difficult laryngoscopy in obese vs non-obese |
1.5 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare RHTDM with another parameter like BMI, NC, TMD & as a predictor of difficult laryngoscopy in obese & non-obese. |
one & half year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/02/2025 |
| 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 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
|
Ratio of Height to Thyromental Distance vs Ratio of Neck Circumference to Thyromental Distance as a Predictor of Difficult Laryngoscopy in Obese vs Non-obese- A Prospective Observational Comparative Study with the primary objective To compare which one among RHTDM Vs NC/TMD is a better predictor of difficult laryngoscopy in obese vs non-obese and secondary objective to compare RHTDM with another parameter like BMI, NC, TMD and as a predictor of difficult laryngoscopy in obese and non-obese. |