| CTRI Number |
CTRI/2025/07/089914 [Registered on: 01/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Difficult airway assesment using USG during surgery. |
|
Scientific Title of Study
|
Clinical and USG parameter for airway assesement in correlation with Cormack-Lehane grade: An observation 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 |
Dr Veena Mathur |
| Designation |
Senior proffesor |
| Affiliation |
Jawahar Lal Nehru medical college and hospital, Kalabagh, Ajmer, Rajasthan |
| Address |
Department of anaesthesiology, new OT, first floor, JLN hospital, Kalabagh, Ajmer, Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9460517947 |
| Fax |
|
| Email |
veenamathur41@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena Mathur |
| Designation |
Senior proffesor |
| Affiliation |
Jawahar Lal Nehru medical college and hospital, Kalabagh, Ajmer, Rajasthan |
| Address |
Department of anaesthesiology, new OT, first floor, JLN hospital, Kalabagh, Ajmer, Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9460517947 |
| Fax |
|
| Email |
veenamathur41@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena Mathur |
| Designation |
Senior proffesor |
| Affiliation |
Jawahar Lal Nehru medical college and hospital, Kalabagh, Ajmer, Rajasthan |
| Address |
Department of anaesthesiology, new OT, first floor, JLN hospital, Kalabagh, Ajmer, Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9460517947 |
| Fax |
|
| Email |
veenamathur41@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology, new OT, first floor, JLN hospital, Kalabagh, Ajmer, Rajasthan 305001 |
|
|
Primary Sponsor
|
| Name |
JLN medical college |
| Address |
Department of anaesthesiology, new OT, first floor, JLN hospital, Kalabagh, Ajmer, Rajasthan 305001 |
| 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 Maneesh Kumar Saroj |
JLN medical college and hospital, Kalabagh, Ajmer, Rajasthan |
Department of anaesthesiology, new OT, first floor, JLN hospital, Kalabagh, Ajmer, Rajasthan
Ajmer
RAJASTHAN |
6378525974
msaroj567@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethecal committee Jawarlal Nehru medical college, Ajmer |
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 |
| Comparator Agent |
Group B clinical parameter |
clinical parameters includes-mallampati grade,thyromental distance,sternomental distance,neck circumferance |
| Comparator Agent |
Group A- USG parameter
|
1)USG parameter includes preepiglottic space,
hyoid bone to skin distance,
skin to epiglottis distance, skin to anterior commissure distance of vocal cord
2)Clinical parameter includes - Mallampati grade
Thromental distance
Sternocostal distance
Neck circumference
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients under going elective surgery under general anaesthesia
|
|
| ExclusionCriteria |
| Details |
Rapid sequence induction
Cervical spine injury
Fiberoptic tracheal intubation
Pregnancy
Not willing patients |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
- To evaluvate USG parameter in predicting difficult airway
- To evaluvate the clinical parameter in predicting difficult airway
In patient undergoing for elective surgery under general anaesthesia |
baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine correlation between USG parameter & clinical parameter for prediction of difficult visualisation of larynx |
Baseline |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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="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 study will be prospective observational study to study and compare clinical parameter and USG parameter in predicting difficult airways in patient undergoing elective surgery under general anaesthesia Primary objective of this study to evaluate USG parameter in predicting difficult airway to evaluate clinical parameter in predicting difficult airway ,to determine the correlation between USG and clinical parameter. All the patients will be subjected to detailed history, complete physical as well as systemic examination and required USG parameter recorded before surgery in preoperative checkup. Patient’s required parameters, routine and all relevant investigations will be checked. The purpose and protocol of the study will be explained to the patients and informed written consent will be obtained. In the operating room a standardized anesthesia technique will be followed to give anaesthesia to patient. Laryngoscopy will be performed and the laryngoscopic view will be graded using modified Cormack Lehane grading. All the parameter will be recorded and documented and analyzed using standard qualitative and quantitative test.
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