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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 

 
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