| CTRI Number |
CTRI/2023/10/058551 [Registered on: 12/10/2023] Trial Registered Prospectively |
| Last Modified On: |
11/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
measuring the diameter of a vein called the subclavian to predict a fall in blood pressure of a patient while undergoing general anaesthesia for surgeries |
|
Scientific Title of Study
|
Pre anaesthetic ultrasound assessment of subclavian vein collapsibility for predicting hypotension following induction under general anaesthesia |
| 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 Vridhi Rajan |
| Designation |
Senior resident |
| Affiliation |
Dr BR ambedkar medical college and hospital |
| Address |
Department of anaesthesia
Dr BR ambedkar medical College and hospital,kadugondanahalli,
Bengaluru 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
|
| Fax |
|
| Email |
vridhir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SALIM IQBAL M |
| Designation |
professor |
| Affiliation |
Dr BR ambedkar medical college and hospital |
| Address |
Department of anaesthesia
Dr BR ambedkar medical College and hospital,kadugondanahalli,
Bengaluru 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
|
| Fax |
|
| Email |
drsalim_iqbal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vridhi Rajan |
| Designation |
Senior resident |
| Affiliation |
Dr BR ambedkar medical college and hospital |
| Address |
Department of anaesthesia
Dr BR ambedkar medical College and hospital,kadugondanahalli,
Bengaluru 560045
KARNATAKA
560045
India |
| Phone |
|
| Fax |
|
| Email |
vridhir@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anaesthesiology department
Dr BR Ambedkar medical college,kadugondanahalli, Bangalore,560045 |
|
|
Primary Sponsor
|
| Name |
Dr BR ambedkar medical college |
| Address |
Dr BR ambedkar medical college and hospital kadugondanahalli,bangalore |
| Type of Sponsor |
Private 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 VRIDHI RAJAN |
DR. B.R. AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
Department of anaesthesia,Dr BR Ambedkar medical College,Kadugondanahalli,Bengaluru, Karnataka 560045
Bangalore
KARNATAKA |
9964059953
vridhir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of DR BR Ambedkar medical college |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) patients posted for elective surgery under general anaesthesia
2) American anaesthesiologist association physical status 1 and 2 |
|
| ExclusionCriteria |
| Details |
1)Patient with peripheral vascular disease
2)Cardiovascular disease
3)Hepatic and renal complications
4)Circulatory instability
5)Patients on ACEI and ARB classess of antihypertensives |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the pre anesthetic subclavian vein ultrasonographic diameter variation with passive leg raising. |
change in diameter will be assessed after 30 seconds of bilateral passive leg raising. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To find out subclavian vein diameter collapsibility index in supine & with passive leg raising
2) To evaluate hemodynamic responses following general anaesthesia |
baseline,2 minutes, 4 minutes, 6 minutes,8 minutes, 10 minutes |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
20/10/2023 |
| 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 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
|
Perioperative hypotension increases postoperative complication rates and prolongs postoperative recovery time. Whether the Passive Leg Raising test (PLR) and Subclavian Vein Diameter(DSCV) can effectively predict post-anesthesia hypotension remains to be tested. |