| CTRI Number |
CTRI/2025/09/094316 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
06/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of ultrasound-guided measurement of hyomental distance ratio with tongue thickness as predictors of difficult laryngoscopy in patients undergoing general anesthesia:A Cross Sectional Observational Study. |
|
Scientific Title of Study
|
Comparison of ultrasound guided measurement of hyomental distance ratio with tongue thickness as predictors 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 |
DEEPA CHOUDHARY |
| Designation |
PG ANAESTHESIA |
| 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 |
9588040694 |
| Fax |
|
| Email |
deepachoudharymho@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PN Shivpriya |
| Designation |
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 |
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
|
|
|
Primary Sponsor
|
| Name |
ABVIMS and DR RML HOSPITAL |
| Address |
Department of Anaesthesia, ABVIMS and DR.RML HOSPITAL, 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 |
| DEEPA CHOUDHARY |
ABVIMS and DR. RML HOSPITAL |
Department of Anaesthesia, ABVIMS and DR. RML HOSPITAL,Connaught place New Delhi 110001
New Delhi
DELHI |
9588040694
deepachoudharymho@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE , ABVIMS AND RML HOSPITAL, NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: B||Imaging, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient undergoing general anaesthesia, ASA class 1 and 2 |
|
| ExclusionCriteria |
| Details |
Obese patient with BMI more than 30, Pregnant females, Patient with anticipated difficult airway, Patient with past history of tracheostomy, Patient with past history of trauma and surgery, Patient with burn contracture to the cranial, cervical and facial region, Patient with restricted mobility of the neck and mandible. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tongue thickness and ratio of hyomental distance in neutral and extended postion.Cormack and Lehane grading for difficult laryngoscopy. |
Preoperative and During the time of induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Difficult intubation assessed by:
1.Number of attempts of intubation.
2.Time taken for intubation.
3.Requirement of any device like stylet or bougie.
4.Requirement of any external maneuver or technique.
5.Change of equipment. |
Preoperative. |
Difficult intubation assessed by:
1.Number of attempts of intubation.
2.Time taken for intubation.
3.Requirement of any device like stylet or bougie.
4.Requirement of any external maneuver or technique.
5.Change of equipment. |
During the time of induction under general Anesthesia for patient posted for surgery. |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
23/09/2025 |
| 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
|
This is a Comparative Observational Study to compare ultrasonographically measured hyomental distance ratio with tongue thickness as predictors of difficult laryngoscopy in patients undergoing general anesthesia to be conducted in ABVIMS and DR. RML Hospital,New Delhi-110001. Sample Size=46.
The primary objective is to compare ultrasound guided measurement of hyomental distance ratio with tongue thickness as predictors of difficult laryngoscopy as assessed by Cormack Lehane grading in patients undergoing general anesthesia.
The secondary objective is to compare ultrasound guided measurement of hyomental distance ratio with tongue thickness as predictors of difficult intubation in patients undergoing general anesthesia. |