| CTRI Number |
CTRI/2025/04/083970 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TEE in paediatric cardiac surgery |
|
Scientific Title of Study
|
Routine Intraoperative Transesophageal Echocardiography (TEE) on Surgical
Management in Paediatric Cardiac Surgery: Impact and Cost-effective analysis.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alok kumar |
| Designation |
Prof |
| Affiliation |
Armed Forces Medical College |
| Address |
Sholapur Road, Pune
Pune MAHARASHTRA 411040 India |
| Phone |
8146044104 |
| Fax |
|
| Email |
mipayal07@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Alok kumar |
| Designation |
Prof |
| Affiliation |
Armed Forces Medical College |
| Address |
Sholapur Road, Pune
MAHARASHTRA 411040 India |
| Phone |
8146044104 |
| Fax |
|
| Email |
mipayal07@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Alok kumar |
| Designation |
Prof |
| Affiliation |
Armed Forces Medical College |
| Address |
Sholapur Road, Pune
MAHARASHTRA 411040 India |
| Phone |
8146044104 |
| Fax |
|
| Email |
mipayal07@gmail.com |
|
|
Source of Monetary or Material Support
|
| DGAFMS and Min of Defence (DRDO)
O/o DGAFMS
A Block, 5F
MoD Office Complex
Africa Avenue
New Delhi-110023
India |
|
|
Primary Sponsor
|
| Name |
DGAFMS |
| Address |
Ministry of Defence, Defence Officers Complex, Africa Avenue, 5th Floor, A Block, New Delhi-110023 |
| Type of Sponsor |
Government funding agency |
|
|
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 Alok Kumar |
Crdiothoracic OT, AFMC |
CTVS Complex, first floor, AICTS Building
AFMC, solapur Road
Pune-411040 Pune MAHARASHTRA |
8146044104
mipayal07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics committee, AFMC, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q20-Q28||Congenital malformations of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Paediatric patients (less than 18 yrs) with congenital heart disease (cyanotic or acyanotic) undergoing on-pump cardiac surgery for correction of defect at the Army Institute of Cardiothoracic Sciences, AFMC for various indications |
|
| ExclusionCriteria |
| Details |
Patients in whom TEE is not inserted due to various reasons (history of dysphagia or prior esophageal surgery, unrepaired tracheoesophageal fistula, esophageal diseases, like stricture, diverticulum or varices, severe coagulopathy, and seropositivity for hepatitis viruses or human immunodeficiency virus and patient on the antiplatelet agent, low molecular weight heparin or heparin infusion) will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the proportion of alterations in surgical management (including the need for repeat bypass run) due to TEE findings. |
Perioperative period (immediate before surgery and immediately after surgery) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cost effective analysis of the change in surgical and postop medical management due to new findings, residual lesions, and rerun of bypass. |
Perioperative period (immediate before surgery and immediately after surgery) |
|
|
Target Sample Size
|
Total Sample Size="138" Sample Size from India="138"
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)
|
21/04/2025 |
| 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="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
|
Transesophageal echocardiography (TEE) preoperative in paediatric cardiac surgery has many applications. Over the past few decades, perioperative echocardiography has solidified its role as a critical diagnostic and perioperative management tool for patients with congenital heart disease (CHD). Perioperative TEE has proved to be invaluable in confirming the preoperative diagnosis, formulating the surgical plan, evaluating immediate operative results, identifying patients with residual defects, and guiding surgical revisions. Residual lesion or defect after cardiac surgery is known and this not only hampers the fast-tracking of the patient but also utilises huge resources of the institute while the patient stays on a ventilator and in ICU. After standard non-invasive monitoring, anaesthesia will be induced. TEE probe will be inserted after induction of the child and standard images will be recorded. Examinations will be performed using GE Vivid T8 echocardiography platform. Relevant images will be stored for future review and comparison. Heart rate (HR), systolic, diastolic, mean arterial blood pressure (MAP), and oxygen saturation will be invasively monitored throughout the surgery. All surgical procedures will be performed by experienced surgeons using standardized techniques. Cardiopulmonary bypass (CPB) and anaesthesia management will be performed according to our standard operating procedures. Any change or modification in the surgical management will be noted before the start of the surgery and after coming off bypass to look for adequacy of surgical correction, cardiac function, and any significant residual lesion and the findings will be conveyed to the operating surgeon. Any significant residual lesion, requiring surgical revision or a second CPB will be noted as an impact of TEE on surgical decision-making. TEE examination will also be repeated after the second CPB. The patients will be observed and evaluated for residual lesions and complications during the ICU stay. Apart from the demographic profile of the patient collected operative data will include aortic cross-clamping (CCT), and cardiopulmonary bypass (CPB). Any adverse events will be recorded. ICU measurements, postop ICU stay, Duration of MV, and any TEE-related adverse event. The cost benefit analysis will be done from health care providers prespective and incremental cost effectiveness ratio would be calculated. |