| CTRI Number |
CTRI/2023/08/056056 [Registered on: 03/08/2023] Trial Registered Prospectively |
| Last Modified On: |
01/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Ultrasound Guided Measurement Of Carotid artery Parameters as a Guide For Fluid Administration in Patients With Shock |
|
Scientific Title of Study
|
Ultrasound Guided Measurement Of Corrected Carotid Flow Time As A Guide For Fluid Administration In Patients With Shock |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Kumari |
| Designation |
Post graduate resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground Floor, Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi,110029,India
South West
DELHI
110029
India |
| Phone |
8826609123 |
| Fax |
|
| Email |
pk939246@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kapil Gupta |
| Designation |
Professor and Consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground Floor, Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi,110029,India
South West
DELHI
110029
India |
| Phone |
9811859019 |
| Fax |
|
| Email |
kapilguptauhn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Chhabra |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground Floor, Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi,110029,India
South West
DELHI
110029
India |
| Phone |
9625154535 |
| Fax |
|
| Email |
priyankahsinghani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, Ground floor, Main OT building, Vardhman Mahavir Medical College and Hospital, Ansari Nagar, New Delhi,110029,India |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi,110029,India |
| 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 Priyanka Kumari |
Safdarjung Hospital |
Department of Anaesthesia and Intensive Care, Ground Floor, Main Operation Theatre building, Vardhman Mahavir Medical College and Ansari Nagar, New Delhi,110029,India
South West
DELHI |
8826609123
pk939246@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee VMMC and SJH |
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
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Passive leg raise maneuver |
Patients will be put in a 45 degree semi-recumbent position for 10 minutes followed by 45 degree elevation of foot end. Parameters will recorded before and after 120 sec of onset of passive leg raising maneuver. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with persistent vasopressor requirement |
|
| ExclusionCriteria |
| Details |
Patients with:
1.Known case of Cardiac dysfunction
2.Pulmonary hypertension
3.Morbid Obesity(BMI>40kg/m2)
4.Carotid artery stenosis
5.Acute respiratory distress syndrome |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess if ultrasound assessment of the change in corrected carotid flow time induced by passive leg raise maneuver be used as a predictor of fluid responsiveness in patients with shock. |
Patients will be placed in semi-recumbent position at 45 degree for 10 minutes. Baseline measurements of parameters before PLR and 120 sec after PLR maneuver. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess if ultrasound guided measurement of carotid artery diameter & cardiac index induced by PLR maneuver be used as a guide for fluid administration in patients with shock.
|
Measured before PLR maneuver & 120 seconds after PLR maneuver. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/08/2023 |
| 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="8"
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 is a prospective interventional study to assess doppler ultrasound derived parameters like- corrected carotid flow time, carotid artery diameter as reliable predictors of fluid responsiveness in patients with shock after passive leg raising (PLR) maneuver. |