| CTRI Number |
CTRI/2024/10/075548 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Learning outcome of Routine Ultrasound Training of Second year Anaesthesia postgraduate in landmark identification of supraclavicular Brachial plexus |
|
Scientific Title of Study
|
A Cross Sectional observational study of learning outcome of Routine Ultrasound Training for Landmark Identification in supraclavicular Brachial plexus Block among Second year Residents in Department of Anaesthesia at SMS Medical College ,Jaipur |
| 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 Vandana Mangal |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College,Jaipur |
| Address |
Department of Anaesthesiology, second floor, Dhanwantari Building , JLN marg , Jaipur
Jaipur
RAJASTHAN
302001
India |
| Phone |
9829056816 |
| Fax |
|
| Email |
vandanamangal25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Mangal |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College,Jaipur |
| Address |
Department of Anaesthesiology, second floor, Dhanwantari Building , JLN marg , Jaipur
Jaipur
RAJASTHAN
302001
India |
| Phone |
9829056816 |
| Fax |
|
| Email |
vandanamangal25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit prakash |
| Designation |
PG student |
| Affiliation |
Sawai Man Singh Medical college, Jaipur |
| Address |
Department of Anaesthesiology, second floor, Dhanwantari Building , JLN marg , Jaipur
Jaipur
RAJASTHAN
302001
India |
| Phone |
8507387710 |
| Fax |
|
| Email |
dr.amitkumar90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia
SMS medical college and hospital jaipur Rajasthan 302004 |
|
|
Primary Sponsor
|
| Name |
Sawai Man Singh Medical College and Hospital |
| Address |
Department of Anaesthesiology , Second floor, Dhanwantari OPD block,SMS Hospitals ,Jaipur |
| 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 Vandana Mangal |
SMS MEDICAL COLLEGE AND HOSPITAL |
Department of anaesthesia
Dhanvanthri building
Trauma OT
Jaipur
RAJASTHAN |
9829056816
vandanamangal25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OFFICE OF THE ETHICS COMMITTEE, S.M.S. MEDICAL COLLEGE AND ATTACHED HOSPITALS ,JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No medical illness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Age 25 to 40 years
Second year residents in department of Anaesthesia |
|
| ExclusionCriteria |
| Details |
Not willing to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Success rate and number of attempts to identify landmarks on usg scanning of supra clavicular area for brachialplexus block and time taken for the same |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe which structures are difficult to identify on USG scanning. |
Baseline |
|
|
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)
|
01/11/2024 |
| 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="0"
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
|
Data collection is done in a cross sectional observational study of learning outcome of routine ultrasound training for landmark identification in supraclavicular brachial plexus block among second year residents |