| CTRI Number |
CTRI/2024/01/061134 [Registered on: 05/01/2024] Trial Registered Prospectively |
| Last Modified On: |
01/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assesment of volume responsiveness at different tidal volumes in OP CABG cases
|
|
Scientific Title of Study
|
Evaluationofvolumeresponsivenessbyleftventricular
enddiastolicvolumevariations,pulsepressurevariationandinferiorvena
cava dispensability index at different tidal volumes in off pump cabg 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 Jigisha Pujara |
| Designation |
Professor in Cardiac Anaesthesiology |
| Affiliation |
U. N. Mehta Institute of Cardiology and Research Centre |
| Address |
Department of Cardiac anesthesia, B block 8th floor, U.N.Mehta Institute Of Cardiology and Research Center,Civil Hospital Campus,Asarwa,Ahemdabad-380016,Gujarat,India
Ahmadabad
GUJARAT
380016
India |
| Phone |
9375018848 |
| Fax |
|
| Email |
jigishajayesh@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jigisha Pujara |
| Designation |
Professor in Cardiac Anaesthesiology |
| Affiliation |
U. N. Mehta Institute of Cardiology and Research Centre |
| Address |
Department of Cardiac Anesthesia ,B block, 8th floor, U.N.Mehta Institute Of Cardiology and Research Center,Civil Hospital Campus,Asarwa,Ahemdabad-380016,Gujarat,India
GUJARAT
380016
India |
| Phone |
9375018848 |
| Fax |
|
| Email |
jigishajayesh@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jigisha Pujara |
| Designation |
Professor in Cardiac Anaesthesiology |
| Affiliation |
U. N. Mehta Institute of Cardiology and Research Centre |
| Address |
B block, 8th floor, Department of Cardiac Anesthesia,U.N.Mehta Institute Of Cardiology and Research Center,Civil Hospital Campus,Asarwa,Ahemdabad-380016,Gujarat,India
GUJARAT
380016
India |
| Phone |
9375018848 |
| Fax |
|
| Email |
jigishajayesh@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Cardiac Anesthesia, U.N.Mrhta Institute of Cardiology and Research Center |
|
|
Primary Sponsor
|
| Name |
UNMehta Institute of Cardiology and Research Center |
| Address |
U.N.Mehta Institute Of Cardiology and Research Center,Civil hospital, Haripura, Asarwa, Ahmedabad, Gujarat 380016 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Jigisha Pujara |
Department of Cardiac Anesthesia, U. N. Mehta Institute of Cardiology and Research Centre |
U.N.Mehta Institute Of Cardiology and Research Center,Civil Hospital Campus,Asarwa,Ahemdabad-380016,Gujarat,India
Ahmadabad
GUJARAT |
9375018848
jigishajayesh@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- UNMICRC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I998||Other disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
NIL |
|
| ExclusionCriteria |
| Details |
Altered renal function tests and liver function tests
On pump CABG
Associated valvular diseases
Preoperative ventilation
Preoperative hemodynamic instability
Patients with lung pathology
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Using TV challange ti overcome the limitation associated with pulse pressure ventilation during low tidal volume ventilation. |
6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evalution of volume responsiveness by inferion vena cava distansibility index at different tidal volume. |
6 month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/01/2024 |
| 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="1"
Months="0"
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
|
Background: •Accurate
assessment of intravascular fluid status and measurement of fluid
responsiveness is important since inadequate and excessive fluid replacement
can affect postoperative clinical outcomes of surgical patients• Intermittent
positiveâ€pressure
ventilation produces cyclic changes in LV stroke volume, which is maximum
during inspiration and lowest during expiration.• The
magnitude of change in LV stroke volume, or of its surrogates, such as pulse
pressure, will be magnified when the patient is preloadâ€dependent. •A
high SVV or PPV value is associated with preload responsiveness and a low SVV
or PPV value with preload unresponsiveness •Left
ventricular end diastolic
volume
(LVEDV) could be easily estimated by left ventricular diameter in short axis
using M mode in echocardiography.•Variation
of LVEDV (LVEDVV) is a parameter to predict fluid responsiveness. However, the
ability of LVEDVV to predict fluid responsiveness has not been fully evaluated.•We
design this study to evaluate ability of LVEDVV measured by TEE to predict
fluid responsiveness, and the relationship and the agreement between LVEDVV and
SVV in patients undergoing off pump CABG.
AIM :To evaluate
volume responsiveness by
left ventricular end diastolic volume variations, pulse pressure variation and
inferior vena cava dispensability index at different tidal volumes in
off pump CABG patients
•OBJECTIVES: To measure the left ventricle end diastolic parameters, PPV and IVC
diameter during tidal volume change and compare them with SVV for fluid
responsiveness
•In
our study, we will examine the effects of varying tidal volumes on PPV, LVEDVV estimated by left ventricular diameter
in short axis using M mode (in TEE), IVC diameters and their validity in
monitoring perioperative fluid responsiveness in
patients undergoing off pump CABG |