| CTRI Number |
CTRI/2023/11/060316 [Registered on: 29/11/2023] Trial Registered Prospectively |
| Last Modified On: |
20/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of electrocardiometry for improving patient health and outcome after heart surgery in patients born with heart diseases |
|
Scientific Title of Study
|
Clinical utility of electrocardiometry based parameters in the management of patients with congenital heart diseases undergoing corrective 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 Sambhunath Das |
| Designation |
Professor, Department of Cardiac Anaesthesia and Critical Care, AIIMS, New Delhi |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Cardiac Anaesthesia and Critical Care, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
dr_sambhu@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohan S Thottan |
| Designation |
Senior Resident, Department of Cardiac Anaesthesia and Critical Care, AIIMS, New Delhi |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Cardiac Anaesthesia and Critical Care, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8754403502 |
| Fax |
|
| Email |
dr.rohan.s.thottan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohan S Thottan |
| Designation |
Senior Resident, Department of Cardiac Anaesthesia and Critical Care, AIIMS, New Delhi |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Cardiac Anaesthesia and Critical Care, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8754403502 |
| Fax |
|
| Email |
dr.rohan.s.thottan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Cardiac Anaesthesia and Critical Care, AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
Department of Cardiac Anaesthesia and Critical Care AIIMS New Delhi |
| Address |
Department of Cardiac Anaesthesia and Critical Care, AIIMS, New Delhi |
| 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 Rohan S Thottan |
AIIMS, New Delhi |
Cardiothoracic Ward CT3, CT4, CT5, CT6, Department of Cardiothoracic and Vascular Surgery
New Delhi
DELHI |
8754403502
dr.rohan.s.thottan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee for postgraduate research All India Institute of Medical Sciences, Ansari Nagar, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Electrocardiometry monitoring |
Electrocardiometry monitoring is used to manage patients undergoing corrective cardiac surgery for congenital heart diseases by constantly assessing cardiac output and other hemodynamic parameters at every moment. In the intervention group, electrocardiometry monitoring is started by attaching the monitor to ECG stickers on the patient and according to values obtained in the device, we would modify vasopressor support and and give appropriate fluid management. |
| Comparator Agent |
The control group of patients are managed intraoperatively as per institutional protocols. |
The control group of patients will be managed intraoperatively as per institutional protocols without the use of electrocardiometry monitoring. In this group, the patients will be managed as per monitoring that is routinely done for all patients undergoing such surgery in our institution. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Congenital heart disease patients between the age of 1day-15 years, posted for elective corrective surgery. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Emergencyprocedures
3. Cases that require re-exploration after the primary procedure. 4. Patients with univentricular heart diseases.
5. Patients requiring post-operative Extracorporeal membrane oxygenation support. |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of post-operative Low Cardiac Output Syndrome (LCOS)
|
Before induction of anaesthesia(T1), after induction of anaesthesia (T2), post sternotomy(T3), off CPB (T4), after sternal closure (T5), after shifting the patient to the ICU (T6) and the monitoring will be continued on to the 24th hour after surgery at 8hours (T7), 16hours (T8) and 24hours (T9) intervals after completion of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Vasoactive Inotropic Score
2. Major adverse cardiac events
3. Input and Output balance
4. Lactate Level
5. Time till ICU and hospital discharge
6. Mortality
|
Before induction of anaesthesia(T1), after induction of anaesthesia (T2), post sternotomy(T3), off CPB (T4), after sternal closure (T5), after shifting the patient to the ICU (T6) and the monitoring will be continued on to the 24th hour after surgery at 8hours (T7), 16hours (T8) and 24hours (T9) intervals after completion of surgery. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
08/12/2023 |
| Date of Study Completion (India) |
15/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Electrocardiometry is a non invasive method for estimating cardiac output and other haemodynamic parameters. Its use is easy and non invasive when comparing to other available methods for monitoring these haemodynamic parameters. Its use in congenital heart disease patients undergoing corrective surgery is being assessed in our proposed study. |