| CTRI Number |
CTRI/2020/08/027131 [Registered on: 13/08/2020] Trial Registered Prospectively |
| Last Modified On: |
10/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to predict difficult intubation by using ultrasound |
|
Scientific Title of Study
|
CORRELATION OF ULTRASONOGRAPHIC AIRWAY ASSESSMENT WITH CORMACK-LEHANE GRADING IN ADULT PATIENTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Soumya Gupta |
| Designation |
PG Resident |
| Affiliation |
ESI PGIMSR AND HOSPITAL, BASAIDARAPUR |
| Address |
Department of Anaesthesiology, ESI PGIMSR AND HOSPITAL, BASAIDARAPUR
West
DELHI
110015
India |
| Phone |
8787013248 |
| Fax |
|
| Email |
soumya0503@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Kumar Thakur |
| Designation |
HOD Academics, Department of Anaesthesiology |
| Affiliation |
ESI PGIMSR AND HOSPITAL, BASAIDARAPUR |
| Address |
Department of Anaesthesiology, ESI PGIMSR AND HOSPITAL, BASAIDARAPUR
West
DELHI
110015
India |
| Phone |
9350103337 |
| Fax |
|
| Email |
dranilthakur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soumya Gupta |
| Designation |
PG Resident |
| Affiliation |
ESI PGIMSR AND HOSPITAL, BASAIDARAPUR |
| Address |
Department of Anaesthesiology, ESI PGIMSR AND HOSPITAL, BASAIDARAPUR
West
DELHI
110015
India |
| Phone |
8787013248 |
| Fax |
|
| Email |
soumya0503@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESI PGIMSR AND HOSPITAL, BASAIDARAPUR, NEW DELHI |
|
|
Primary Sponsor
|
| Name |
ESI PGIMSR AND HOSPITAL BASAIDARAPUR |
| Address |
Department of Anaesthesiology, ESI PGIMSR AND HOSPITAL, BASAIDARAPUR, NEW DELHI |
| 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 Soumya Gupta |
ESIPGIMSR Basaidarapur |
Department of Anaesthesiology, ESI PGIMSR AND HOSPITAL, BASAIDARAPUR
New Delhi
DELHI |
8787013248
soumya0503@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutuional Ethics Committee, ESIPGIMSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA grade I / II.
2.Patients undergoing elective surgery under general anaesthesia.
|
|
| ExclusionCriteria |
| Details |
Patients with
1. Mouth opening < 3cm
2. ASA grade III/IV.
3. Pregnant females.
4. Having any head or neck pathology.
5. Restricted neck movement.
6. Risk for gastric aspiration, and
7. edentulous patients and patients having artificial denture |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation of Ultrasonographic measurements of Skin to Epiglottis distance at thyrohyoid membrane with CL grading. |
At the time of laryngoscopy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of clinical airway assessment with CL grading. |
Pre operative period |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
14/08/2020 |
| 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="0"
Days="0" |
|
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
|
This study is to assess the reliability of Ultrasound in predicting a difficult airway. The outcome is correlated with Cormack Lehane grading, which is a gold standard to predict difficult airway and hence difficult intubation.
|