| CTRI Number |
CTRI/2024/05/067874 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparison of right heart measurements by perioperative echocardiography as a predictor of hemodynamic instability in patients undergoing elective cardiac surgery |
|
Scientific Title of Study
|
Comparison of right ventricular measurements by perioperative echocardiography as a predictor of hemodynamic instability in patients undergoing elective cardiac surgery- A Cross sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karthikeyan Alagumalai |
| Designation |
Registrar |
| Affiliation |
The Madras Medical Mission Hospital |
| Address |
Department of Cardiac Anesthesiology,
Mogapair
chennai
Chennai
TAMIL NADU
600037
India |
| Phone |
9566459238 |
| Fax |
|
| Email |
keyan.karthiii@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kanagarajan |
| Designation |
Senior Consultant |
| Affiliation |
The Madras Medical Mission Hospital |
| Address |
Department of Cardiac anesthesiology,
The Madras Medical Mission Hospital,
Chennai
TAMIL NADU
600037
India |
| Phone |
9952924218 |
| Fax |
|
| Email |
drkanag@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Karthikeyan Alagumalai |
| Designation |
Registrar |
| Affiliation |
The Madras Medical Mission Hospital |
| Address |
Department of Cardiac Anesthesiology,
mogapair
Chennai
TAMIL NADU
600037
India |
| Phone |
9566459238 |
| Fax |
|
| Email |
keyan.karthiii@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Madras Medical Mission Hospital 4-A, Dr, Mogappair, Chennai, Tamil Nadu 600037 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Karthikeyan |
The Madras Medical Mission Hospital |
Department of cardiac Anesthesiology (first floor)
4-A, Dr. J. Jayalalitha Nagar,
Mogappair
Chennai
TAMIL NADU |
9566459238
keyan.karthiii@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee The Madras Medical Mission Hospital |
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, (2) ICD-10 Condition: I258||Other forms of chronic ischemic heart disease, (3) ICD-10 Condition: I229||Subsequent ST elevation (STEMI) myocardial infarction of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Right Ventricular Functional indices |
To predict hemodynamic instability post operatively(hourly) till 24 hours using RV function assessment by perioperative echocardiography |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients more than 18 years of age undergoing elective cardiac surgery |
|
| ExclusionCriteria |
| Details |
Patient refusal
Contraindication to TEE , Redo surgery,
Ongoing ischemia,
Non-sinus rhythm.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to predict hemodynamic instability by perioperative echocardiography |
post operatively within 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| inotrope requirement, icu stay morbidity & mortality |
24 hours post operative |
|
|
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)
|
01/07/2024 |
| 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 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
|
Comparison of right ventricular measurements by perioperative echocardiography as a predictor of hemodynamic instability in patients undergoing elective cardiac surgery. In this study baseline transthoracic echocardiographic measurements of right ventricular function will be taken before induction of anesthesia followed by transesophageal echocardiography measurements of the same after induction before sternotomy and after sternal closure will be recorded. Hemodynamic parameters and inotrope requirement will be recorded in the post operative period for 24 hours. |