| CTRI Number |
CTRI/2025/07/091822 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
27/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prediction of difficult laryngoscopy by USG quantification of anterior neck soft tissue and tongue thickness |
|
Scientific Title of Study
|
Prediction of difficult laryngoscopy by ultrasound quantification of anterior neck soft tissue and tongue thickness |
| 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 Richa sisodiya |
| Designation |
Post graduate resident |
| Affiliation |
Gandhi medical College bhopal madhya pradesh |
| Address |
2nd floor block-1 department of anaesthesiology Gandhi medical college and associated HamidiaHospital, BHOPAL, MADHYA PRADESH
2nd floor block-1 department of anaesthesiology Gandhi medical college and associated HamidiaHospital, BHOPAL, MADHYA PRADESH
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
8770859115 |
| Fax |
|
| Email |
richasisodiya05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tripti vatsalya |
| Designation |
Associate professor |
| Affiliation |
Gandhi medical college bhopal madhya pradesh |
| Address |
2nd floor block-1 department of anaesthesiology Gandhi medical college and associated HamidiaHospital, BHOPAL, MADHYA PRADESH
2nd floor block-1 department of anaesthesiology Gandhi medical college and associated HamidiaHospital, BHOPAL, MADHYA PRADESH
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9827012052 |
| Fax |
|
| Email |
vdrtripti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tripti vatsalya |
| Designation |
Associate professor |
| Affiliation |
Gandhi medical college bhopal madhya pradesh |
| Address |
2nd floor block-1 department of anaesthesiology Gandhi medical college and associated HamidiaHospital, BHOPAL, MADHYA PRADESH
2nd floor block-1 department of anaesthesiology Gandhi medical college and associated HamidiaHospital, BHOPAL, MADHYA PRADESH
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9827012052 |
| Fax |
|
| Email |
vdrtripti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gandhi medical College, bhopal 462001, INDIA |
|
|
Primary Sponsor
|
| Name |
Gandhi medical College |
| Address |
2nd floor block-1 department of anaesthesiology Gandhi medical college and associated HamidiaHospital, BHOPAL, MADHYA PRADESH |
| 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 Richa sisodiya |
Hamidia hospital |
Second floor department of anaesthesiology hamidia hospital Gandhi medical college bhopal madhya pradesh
Bhopal
MADHYA PRADESH |
8770859115
richasisodiya05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Prediction of difficult laryngoscopy byy USG quantification of anterior neck soft tissue and tongue thickness |
Correlation of these ultrasound measurements with cormack lehane grading at the time of intubation |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
years old patients of either sex scheduled for elective surgery requiring tracheal intubation under general anaesthesia, ASA grade l & ll |
|
| ExclusionCriteria |
| Details |
Patients with tongue deformity
Patients with anterior neck deformity |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate, distance from skin to hyoid bone
Distance from skin to anterior commissure of vocal cord
Ultrasound guided measured tongue thickness |
Every 2 min from study till 10 min after laryngoscopy
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
No. Of intubation attempts
No. Of requirement of BURP
Cormack lehane grading |
Every 2 min from study till 10 min after laryngoscopy |
|
|
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)
|
11/08/2025 |
| 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
|
To determine ultrasound measurement of anterior neck tissue and tongue thickness in prediction of difficult airway, to correlate these ultrasound measurement with cormack lehane grading at the time of intubation patients airway assessment is one of the foremost responsibility of the anesthesiologist .accurate assessment of airway can prevent catastrophic perioperative events like hypoxia, hypercapnia and cardiac events. Currently, laryngeal structures can be measured by ultrasonography, however, little research has been performed on the potential role of ultrasound on the evaluation of a difficult laryngoscopy.The present study will be conducted in Gandhi Medical College and associated Hamidia Hospital, Bhopal. in a total of 90 patients undergoing surgeries under general anaesthesia. After approval by institutional ethics committee and written informed consent, a total of 90 patients of either sex of ASA grade I and II aged between 20 - 60 years of either sex will be included in the prospective observational Study patients will be observed for :- 1) Distance from skin to hyoid bone (DHSB). 2) Distance from skin to anterior commissure of vocal cord(DSAC). 3) Ultrasound guided measurement of Tongue thickness 4) Requirement of BURP & no. Of attempts of laryngoscopy 5) Cormack lehane grading. 6) Haemodynamic variables during intubation ( HR, BP, SBP, DBP and mean BP) |