| CTRI Number |
CTRI/2024/11/076898 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
11/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of two methods,i.e LVOT VTI and SVV, to predict response to fluid in cardiac surgery in children in post operative period |
|
Scientific Title of Study
|
Comparison of the diagnostic accuracy of velocity time integral of left ventricular outflow tract and stroke volume variation in predicting fluid responsiveness in paediatric cardiac surgery patients in post operative ICU care |
| 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 Manoj Kamal |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
All India Institute of Medical Sciences, Jodhpur Cardiothoracic and Vascular Surgery OT sixth floor D&T Block
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9414084584 |
| Fax |
|
| Email |
geethamanoj007@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Kamal |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
All India Institute of Medical Sciences, Jodhpur Cardiothoracic and Vascular Surgery OT sixth floor D&T Block
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9414084584 |
| Fax |
|
| Email |
geethamanoj007@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swasti Jain |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Jodhpur |
| Address |
AICU Department of Anaesthesia and Critical Care 3rd floor D&T block AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9763200811 |
| Fax |
|
| Email |
swastij20199@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Jodhpur, Rajasthan India PIN code-342004 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
AIIMS Jodhpur Rajasthan 342005 |
| 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 Manoj Kamal |
All India institute of Medical Sciences Jodhpur |
601 cardiothoracic and vascular surgery OT 6th floor D and T block AIIMS Jodhpur
Jodhpur
RAJASTHAN |
9414084584
geetamanoj007@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I999||Unspecified disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients undergoing elective cardiac surgery.
2) Age – 1 to 18 years old. |
|
| ExclusionCriteria |
| Details |
1) patients with open chest, arrhythmias and shunts
2) patients with weight less than 3 kg |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find sensitivity, specificity, positive predictive and negative predictive value of LVOT VTI in prediction fluid responsiveness. |
Baseline, post operative day 0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the correlation of VTI-LVOT variability with stroke volume variation (SVV) from arterial pulse pressure recording analytical method (PRAM) for prediction of fluid responsiveness in paediatric patients undergoing cardiac surgery
2. To find the sensitivity, specificity, positive & negative predictive value of LVOT-VTI variability in predicting fluid responsiveness.
3. Note amount of fluid administered & inotrope requirement.
|
Baseline, post operative day 0 |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
25/11/2024 |
| 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="1"
Months="6"
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
|
All patients who will undergo elective cardiac surgery between the ages of 1 and 18years are to be enrolled in the study. Patients with open chest, arrhythmias and shunts are to be excluded. In all patients arterial line to be inserted, either femoral or radial, and will be connected to the MostCare Up monitor for SVV and BP monitoring. SVV and LVOT VTI variability to be measured once at arrival in post operative ICU care. Based on the cut off values of 10% and 12 %, respectively for SVV and LVOT VTS variability, patients to be divided into fluid responsive and non responders. If responsive, a fluid challenge of of 10ml/kg of crystalloids to be given over 20 minutes and values to be recorded again. If patient is still responsive another bonus is to be given. |