| CTRI Number |
CTRI/2024/03/064688 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
07/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Compare the ultrasound-based hyomental distance ratio to the thyromental distance to predict difficult laryngoscopy in people having general anesthesia. |
|
Scientific Title of Study
|
Comparison of Ultrasonographically measured Hyomental distance ratio with Thyromental distance as predictor of difficult laryngoscopy in patients undergoing general anesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUMIT KUMAR |
| Designation |
POST GRADUATE |
| Affiliation |
ABVIMS and DR. RML Hospital |
| Address |
Department of anaesthesia, ABVIMS and DR. RML HOSPITAL, Baba Kharak Singh road Connaught place New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9582927616 |
| Fax |
|
| Email |
sumit06041997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PN SHIVPRIYA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ABVIMS and DR. RML Hospital |
| Address |
Department of anaesthesia, ABVIMS and DR. RML HOSPITAL, Baba Kharak Singh road Connaught place New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9868357600 |
| Fax |
|
| Email |
dr.shivpriya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PN SHIVPRIYA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ABVIMS and DR. RML Hospital |
| Address |
Department of anaesthesia, ABVIMS and DR. RML HOSPITAL, Baba Kharak Singh road Connaught place New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9868357600 |
| Fax |
|
| Email |
dr.shivpriya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia, ABVIMS and DR. RML HOSPITAL, Baba Kharak Singh road Connaught place New Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
ABVIMS and DR. RML Hospital |
| Address |
Department of anaesthesia, ABVIMS and DR. RML HOSPITAL, Baba Kharak Singh road Connaught place New Delhi 110001 |
| 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 |
| SUMIT KUMAR |
ABVIMS and DR. RML Hospital |
Department of anaesthesia, ABVIMS and DR. RML HOSPITAL, Baba Kharak Singh road Connaught place New Delhi 110001
New Delhi
DELHI |
9582927616
sumit06041997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE ,ABVIMS AND DR. RML HOSPITAL, NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hyomental distance ratio and thyromental distance |
COMPARISON OF ULTRASONOGRAPHICALLY MEASURED HYOMENTAL DISTANCE RATIO WITH THYROMENTAL DISTANCE AS PREDICTOR OF DIFFICULT LARYNGOSCOPY IN PATIENTS UNDERGOING GENERAL ANESTHESIA
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA class 1 and 2 |
|
| ExclusionCriteria |
| Details |
patient with tracheostomy,neck fracture,burns and contracture to the cervical,facial and cranial region,fibrosis,obese patients and patient with past history of neck surgery and pregnat females and patient with restricted mobility of neck |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cormack and Lehane grading for difficult laryngoscopy |
Preoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of attempts of intubation
,time taken for intubation
,requirement of any device like stylet or bougie
,requirement of any external maneuver or technique,change of equipment
|
Preoperative |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/04/2024 |
| 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 randomised comparative and prospective study to compare ultrasonographically measured hyomental distance ratio with thyromental distance as predictor of difficult laryngoscopy in patients undergoing general anesthesia.to be conducted in ABVIMS and DR. RML Hospital,New Delhi-110001. Sample Size=50
The primary objective is to comparative evaluation of Ultrasonographically measured Hyomental distance ratio with Thyromental distance as a predictor of difficult Laryngoscopy in patients undergoing general anaesthesia by Comark and Lehane grading.
The secondar objective is comparative evaluation of Ultrasonographically measured Hyomental distance ratio with Thyromental distance as a predictor of difficult intubation in patients undergoing general anaesthesia . |