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CTRI Number  CTRI/2019/06/019743 [Registered on: 18/06/2019] Trial Registered Prospectively
Last Modified On: 19/07/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Feasibility of transesophageal echocardiographic measurement of right heart function and their interchangeability with transthoracic echocardiographic measurements 
Scientific Title of Study   The feasibility of measurement of different right ventricular systolic function parameters by intraoperative transesophageal echocardiography and their interchangeability with transthoracic echocardiography in paediatric patients undergoing cardiac surgery  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Indranil Biswas 
Designation  Senior Resident 
Affiliation  Postgraduate Institute of Medical Education and Research, Chandigarh 
Address  Room No. 4016, Advanced Cardiac Centre, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  2755065  
Fax    
Email  hreesheekombartta@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Indranil Biswas 
Designation  Senior Resident 
Affiliation  Postgraduate Institute of Medical Education and Research, Chandigarh 
Address  Room No. 4016, Advanced Cardiac Centre, PGIMER, Chandigarh


CHANDIGARH
160012
India 
Phone  2755065  
Fax    
Email  hreesheekombartta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Indranil Biswas 
Designation  Senior Resident 
Affiliation  Postgraduate Institute of Medical Education and Research, Chandigarh 
Address  Room No. 4016, Advanced Cardiac Centre, PGIMER, Chandigarh


CHANDIGARH
160012
India 
Phone  2755065  
Fax    
Email  hreesheekombartta@gmail.com  
 
Source of Monetary or Material Support  
PGIMER Chandigarh 
 
Primary Sponsor  
Name  Postgraduate Institute of Medical Education and Research Chandigarh 
Address  PGIMER, Chandigarh. Sector 12. Chandigarh (U.T). Pin 160012 
Type of Sponsor  Government medical college 
 
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 
Indranil Biswas  PGIMER Chandigarh  CTVS OT Cardiac Anaesthesia Division Dept of Anaesthesia and Intensive Care Advanced Cardiac Centre PGIMER Chandigarh Chandigarh (U.T) Pin 160012
Chandigarh
CHANDIGARH 		 7710449858

hreesheekombartta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q255||Atresia of pulmonary artery, (2) ICD-10 Condition: Q211||Atrial septal defect, (3) ICD-10 Condition: Q212||Atrioventricular septal defect, (4) ICD-10 Condition: Q251||Coarctation of aorta, (5) ICD-10 Condition: Q203||Discordant ventriculoarterial connection, (6) ICD-10 Condition: Q201||Double outlet right ventricle, (7) ICD-10 Condition: Q208||Other congenital malformations ofcardiac chambers and connections, (8) ICD-10 Condition: Q218||Other congenital malformations ofcardiac septa, (9) ICD-10 Condition: Q250||Patent ductus arteriosus, (10) ICD-10 Condition: Q213||Tetralogy of Fallot, (11) ICD-10 Condition: Q210||Ventricular septal defect,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Patients of either sex of the age group 1 year to 18 years, undergoing surgery for correction or palliation of congenital heart diseases  
 
ExclusionCriteria 
Details  1. Patients having contraindications to insertion of TEE transducer
2. Patients weighing less than 10 kg
3. Patients having organic disease of tricuspid valve
4. Patients on pacemaker
5. Patients having heart rhythm other than normal sinus rhythm
6. Patients having poor TTE window
7. Pericardial disease
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find out the feasibility of measuring the RV systolic function parameters intraoperatively using different views of transesophageal echocardiography in adults undergoing cardiac surgery
and also to evaluate the interchangeability of these measurements with those measured by transthoracic echocardiography.
 		 Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1. To find out the best TEE view for measuring each of the individual parameters.
2. To find out the single best TEE view as compared to TTE, for measuring all the parameters.
 		 Baseline 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/07/2019 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
Background- Right ventricular systolic function parameters are standardised based upon transthoracic echocardiographic measures only. However, transesophageal echocardiography is the mainstay during intraoperative period. Whether right ventricular function assessment using transesophageal echocardiography is feasible and whether the measurements are interchangeable with those measured by transthoracic echocardiography- is not known,
Purpose- A single centre, prospective observational study to   find out the feasibility of measuring the RV systolic function parameters intraoperatively using different views of transesophageal echocardiography in adults undergoing cardiac surgery and also to evaluate the interchangeability of these measurements with those measured by transthoracic echocardiography.
 
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