| CTRI Number |
CTRI/2021/09/036422 [Registered on: 10/09/2021] Trial Registered Prospectively |
| Last Modified On: |
10/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [USG Guided measurement of tongue thickness ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating tongue thickness using ultrasound to determine difficult laryngoscopy in obese patients undergoing elective surgery |
|
Scientific Title of Study
|
Evaluation of ultrasound guided measurement of tongue thickness in predicting difficult laryngoscopy in obese patients undergoing elective surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dheeraj Singh |
| Designation |
PG Resident |
| Affiliation |
ABVIMS AND DR RMLH |
| Address |
Department of anaesthesia
ABVIMS and DR RMLH
Department of anaesthesia
ABVIMS and DR RMLH
New Delhi
DELHI
110001
India |
| Phone |
8750388314 |
| Fax |
|
| Email |
dhirubhai2510@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nisha Kachru |
| Designation |
Professor |
| Affiliation |
ABVIMS AND DR RMLH |
| Address |
ABVIMS AND DR RMLH Baba kharak Singh marg
New Delhi
DELHI
110001
India |
| Phone |
9810488435 |
| Fax |
|
| Email |
nishakachru@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Nisha Kachru |
| Designation |
Professor |
| Affiliation |
ABVIMS AND DR RMLH |
| Address |
ABVIMS AND DR RMLH Baba kharak Singh marg
DELHI
110001
India |
| Phone |
9810488435 |
| Fax |
|
| Email |
nishakachru@yahoo.co.uk |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ABVIMS AND DR RMLH |
| Address |
Baba Kharak Singh Marg 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 |
| Dheeraj Singh |
Department of Anaesthesia |
ABVIMS AND DR RMLH NEW DELHI
New Delhi
DELHI |
8750388314
dhirubhai2510@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee,ABVIMS AND DR RMLH New Delhi |
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 |
Not applicable |
Not applicable |
| Intervention |
USG Guided measurement of tongue thickness |
Patient will be positioned in supine mouth closed and tongue touching incisors. 6-13MHz linear ultrasound transducer placed under chin in the median saggital plane. The probe will be adjusted till the entire tongue outline is clearly seen on the screen and the image will be frozen. Maximal vertical dimension from the surface of tongue to the submental skin will be taken as tongue thickness and measured. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 2 and 3,BMI>25kg/meter square |
|
| ExclusionCriteria |
| Details |
Upper airway deformity ,trauma or tumor. Past history of difficult airway. Patient needing rapid sequence intubation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Ultrasound guided measurement of tongue thickness
2.Cormack Lehane grading. |
1. Preoperative
2. During endotracheal intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Number of attempts for intubation
2. Time taken for intubation
3. Use of adjuncts or alternate |
1.During intubation
2. During intubation
3. During intubation |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/09/2021 |
| 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="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is crossing sectional observational evaluating ultrasound guided measurement of tongue thickness to predict difficult laryngoscopy in 40 obese patients undergoing elective surgery.That will be conducted in ABVIMS AND DR RMLH New Delhi.The primary outcome measure will be USG guided measurement of tongue thickness and Cormack Lehane grading and secondary outcome will be number of attempts for intubation,time taken for intubation and use of adjunct or alternate techniques for intubation |