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CTRI Number  CTRI/2020/07/026810 [Registered on: 27/07/2020] Trial Registered Prospectively
Last Modified On: 09/05/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   prospective observational study 
Study Design  Other 
Public Title of Study   Intraoperative Transesophageal Echocardiac evaluation of Aortic valve 
Scientific Title of Study   Intraoperative Transesophageal Echocardiographic evaluation of Aortic valve and its comparison with Preoperative Transthoracic Echo in patients posted for Aortic valve replacement. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aseem Gargava 
Designation  Senior Resident 
Affiliation  Seth GS Medical college 
Address  Department of cardiovascular and thoracic anaesthesia. KEM Hospital
Ernest Borges road, Parel CVTC block, Parel
Mumbai
MAHARASHTRA
400012
India 
Phone  8860494714  
Fax    
Email  aseemgargava@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Aseem Gargava 
Designation  Senior Resident 
Affiliation  Seth GS medical college 
Address  Department of cardiovascular and thoracic anaesthesia. KEM Hospital
Ernest Borges road, Parel
Mumbai
MAHARASHTRA
462023
India 
Phone  9977997812  
Fax    
Email  aseemgargava@gmail.com  
 
Details of Contact Person
Public Query
 
Name  aseem gargava 
Designation  Senior Resident 
Affiliation  Seth GS medical college 
Address  Department of cardiovascular and thoracic anaesthesia. KEM Hospital
Ernest Borges road, Parel CVTC block, Parel
Mumbai
MAHARASHTRA
400012
India 
Phone  8860494714  
Fax    
Email  aseemgargava@gmail.com  
 
Source of Monetary or Material Support  
department of cardiac anaesthesia, seth g.s. medical college, kem hospital, mumbai 
 
Primary Sponsor  
Name  Aseem Gargava 
Address  Department of Cardiovascular and Thoracic Anaesthesia, KEM Hospital, Mumbai 
Type of Sponsor  Other [self] 
 
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 
Manjula Sarkar  Department of Cardiovascular and Thoracic Anaesthesia, P.K. Sen block, KEM hospital  Ernest Borges road, Parel CVTC block, Parel
Mumbai
MAHARASHTRA 
8860494714

drmanjusarkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IECII Seth GSMC and KEM hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I069||Rheumatic aortic valve disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Any patient posted for aortic valve replacement for severe aortic regurgitation without left ventricular dysfunction requiring transesophageal echocardiographic evaluation.
 
 
ExclusionCriteria 
Details  1. age less than 18 years
2. ASA IV or more.
3. patients with contraindication for TEE.
4. Midline redo surgeries.
5. Severe or moderate Aortic stenosis.
6. Severe or moderate Mitral stenosis or regurgitation. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary haemodynamic parameters recommended for clinical evaluation of AR severity:
- Regurgitant volume.
- Regurgitant fraction.
- Effective regurgitant orifice area.
- vena contracta width.
- Diastolic reversal of flow in descending aorta.
 
Preoperatively using Transthoracic echo and Intraoperatively using Transesophageal echo. 
 
Secondary Outcome  
Outcome  TimePoints 
secondary parameters:
- hemodynamic parameters during evaluation,
- any additional TEE findings.
 
- secondary parameters:
- hemodynamic parameters during evaluation,
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/07/2020 
Date of Study Completion (India) 09/04/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Introduction:

Echocardiography is the key tool for the diagnosis and evaluation of aortic regurgitation, and is the primary non-invasive imaging method for AR assessment. Diagnostic cardiac catheterization is no longer recommended except in rare cases when echocardiography is non-diagnostic or discrepant with clinical data. The aortic valve and root can be evaluated by transthoracic (TTE) or transesophageal echocardiography (TEE). However TEE is generally superior to TTE imaging because of the improved resolution of higher frequency TEE probe.
Anatomic evaluation of the aortic valve is based on a combination of short- and long-axis images to identify the number of leaflets, and to describe leaflet mobility, thickness, and calcification. In addition, the combination of imaging and Doppler allows the determination of the level of obstruction; subvalvular, valvular, or supravalvular. Transthoracic imaging usually is adequate, although transesophageal echocardiography (TEE) may be helpful when image quality is suboptimal.
The primary haemodynamic parameters recommended for clinical evaluation of AR severity are:
-Regurgitant volume
-Regurgitant fraction
-Effective regurgitant orifice area 
- Vena contracts width
-Diastolic reversal of flow in descending aorta.

PURPOSE OF STUDY- We want to assess compare  preoperative trans thoracic echocardiography findings with trans esophageal findings and determine which parameters are reliable in detecting the severity of AR.  The effect of anaesthesia drugs may cause changes in haemodynamics which can studied in detail using TEE. Hence, we thought it worthwhile to study the valve and comparatively evaluate it with preoperative TTE.

Aims and objectives - To study the aortic valve apparatus (valve area, valve type, presence of calcification or vegetation and gradients across the valve) and compare it with preoperative transthoracic echocardiography findings.
Inclusion Criteria
- ASA II and III patients of either sex posted for aortic valve replacement for severe AR without left ventricular dysfunction 
Exclusion Criteria
- < 18 years patients
- ASA IV and above patients.
- Midline Redo Surgeries
- Patients with contraindications to TEE probe insertion.
- Patients with moderate to severe mitral pathology or aortic stenosis.

Materials and Methods:
Study area and population: Patients admitted in the in-patient department of Cardiovascular and thoracic Surgery at KEM Hospital and posted for elective aortic valve replacement requiring TEE evaluation intraoperatively.
Study Design: Prospective observational study.
Duration of the study: 6 months.
Place of the study: Seth GS Medical College and KEM Hospital, Mumbai.
Sample size: 40 patients posted for aortic valve replacement over the 6 months period. (The sample size is selected based on the time duration of the study. As we have limited time duration to complete the study, we have selected 40 as the minimum sample size)
Methodology: 
After local ethical committee approval and written informed consent, 40 patients undergoing elective aortic valve replacement will be enrolled for the study.
Pre anaesthesia evaluation will be conducted on a day prior to the study and a detailed history and present complaints will be noted.
Detailed general and systemic examination of the cardiovascular and respiratory system will be done. Routine laboratory investigations will be done. Pre operative transthoracic echocardiographic findings will be noted. All patients will be kept fasting for 8 hours prior to surgery. On the day of surgery, the patient will be wheeled into the operating room and after securing intravenous line, standardized monitors will be applied. Right internal jugular vein and radial artery will be cannulated under local infiltration anaesthesia. Standardized general anaesthesia will be administered to the patients.
With direct laryngoscopy TEE probe will be inserted and aortic valve will be studied in the following views
- 1) Mid esophageal 4 chamber view
- 2) Mid esophageal LVOT long axis(LAX) view
- 3) Mid esophageal aortic valve short axis(SAX) view
- 4) Mid esophageal aortic valve LAX view
- 5) Transgastric LAX view
- 6) Deep Transgastric view
After completing the brief TEE examination of the aortic valve, the findings will be noted and the results will be analysed.
Statistical Analysis
After data collection data entry will be done in Excel sheet and data analysis will be done with the help of statistical software (SPSS version 24.0). Quantitative data like valve area and gradients will be presented with the help of mean, std deviation, median, IQR (Inter Quartile Range). Qualatitative data like valve morphology, type, severity and any findings in aorta will be presented with the help of frequency and percentage tables, association among the various study parameters will be assessed with Chi – Square test.
P value <0.05 will be taken as level of significance.

PUBLICATIONS- none.

 
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