| CTRI Number |
CTRI/2025/07/091270 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
19/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
To study the changes of right ventricle function in patients who are undergoing heart grafting surgery by using echocardiogram before and after grafting of the arteries of the heart |
|
Scientific Title of Study
|
To assess the right ventricular function using transesophageal echocardiogram before and after coronary ypass surgery |
| 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 Cherry J B Kharbudnah |
| Designation |
Post Graduate Resident DM Cardiac Anaesthesia |
| Affiliation |
Sri Rmachandra Institute Of Higher Education and Research |
| Address |
Room no: F-6, Cardiac Anaesthesia Department,Sri Ramachandra Institute of Higher Education and Research
Porur, Chennai
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
8794848683 |
| Fax |
|
| Email |
joannesline@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjith Karthekeyan |
| Designation |
Head of Department and Professor, Department of Cardiac Anaesthesia |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Room no: F-6, Sri Ramachandra Institute of Higher Education and Research
Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9841136568 |
| Fax |
|
| Email |
ranjithb73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Cherry J B Kharbudnah |
| Designation |
Post Graduate Resident DM Cardiac Anaesthesia |
| Affiliation |
Sri Ramachandra Institute Of Higher Education and Research |
| Address |
Room No: F-6, Department of Cardiac Anaesthesia,Sri Ramachandra Institute of Higher Education and Research
Porur, Chennai
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
8794848683 |
| Fax |
|
| Email |
joannesline@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute Of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
Cherry J B Kharbudnah |
| Address |
Room No: F-6, Department of Cardiac Anaesthesia, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai |
| Type of Sponsor |
Other [self financing] |
|
|
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 Cherry J B Kharbudnah |
Sri Ramachandra Institute Of Higher Education And Research |
Department of Cardiac Anaesthesia,Sri Ramachandra Institute Of Higher Education And Research, Porur
Chennai
TAMIL NADU |
8794848683
joannesline@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Ethics Committee Sri Ramachandra Institute Of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
40 |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To measure the right ventricular systolic function
1. longitudinal measures of RV systolic function using TAPSE
2. Global measures of RV systolic function using FAC |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Requirement of vasopressor/ inotrope/ inodilator
Right ventricular failure |
6 Months |
|
|
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)
|
01/08/2025 |
| 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="6"
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
|
Over the years the focus has shifted from Left ventricular to right ventricular function because of the growing evidence of Right ventricular Dysfunction following cardiac surgeries. Right ventricular dysfunction following cardiac surgery is associated with high mortality and morbidity. A decrease in RV function can occur during or immediately after cardiac surgery. Though the mechanism of RV dysfunction is not known, few studies have suggested impaired diastolic function of the right ventricle as one of the major cause of hemodynamic derangements observed during the surgery, other complications are related to poor right sided myocardial preservation with retrograde cardioplegia, increased afterload following cardiopulmonary bypass and air embolism during de airing in on pump coronary artery bypass graft surgery, while there are limited data on RV dysfunction in patients undergoing off pump coronary artery bypasss grafting surgery. Perioperative assessment of RV function is complex and achieved using different parameters. Though the qualitative assessment has good sensitivity it is less specific in terms of differentiation between normal and abnormal RV function. Guidelines of Echocardiographic assessment of Right Ventricle have suggested assessment of atleast FAC ( fractional Area Change), S’, TAPSE( tricuspid annular plane systolic excursion) with or without RV index of myocardial performance.Our study aims to assess change in RV systolic function during CABG surgery using following parameters TAPSE and FAC |