| CTRI Number |
CTRI/2022/02/040453 [Registered on: 21/02/2022] Trial Registered Prospectively |
| Last Modified On: |
02/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To observe how much the measurements of function of right ventricle of heart during its relaxation (diastole) phase agree when measured by echocardiography through esophagus (food-pipe) as compared to the standard echocardiography done from over the chest wall |
|
Scientific Title of Study
|
Agreement Between Transthoracic and Transoesophageal Echocardiography in Measurement of Right Ventricular Diastolic Doppler
and Tissue Doppler Velocities in Adult 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 |
Yukti Sharma |
| Designation |
Junior resident |
| Affiliation |
PGIMER |
| Address |
Department of Anesthesia - cardiac anesthesia division , room no. 4014 4th floor , advanced Cardiac Center Pgimer, Sector 12 pin code : 160012.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8054892551 |
| Fax |
|
| Email |
yuktis14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indranil Biswas |
| Designation |
Assistant professor |
| Affiliation |
Pgimer |
| Address |
Room no. 4014 , Advanced Cardiac centre , Department Of Anesthesia PGIMER, Chandigarh
sector 12 Pin code : 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7710449858 |
| Fax |
|
| Email |
hreesheekombartta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indranil Biswas |
| Designation |
Assistant professor |
| Affiliation |
Pgimer |
| Address |
Room no. 4014 , Advanced Cardiac centre, Department of Anesthesia , PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7710449858 |
| Fax |
|
| Email |
hreesheekombartta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post graduate institute of medical education and research |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Pgimer, Chandigarh sector 12 . Pin code 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| YUKTI SHARMA |
CTVS OT, Level 4 ADVANCED Cardiac center |
Room No. 4014 ADVANCED CARDIAC CENTER : Department Of Anesthesia . Division : Cardiac Anesthesia PGIMER
Chandigarh
CHANDIGARH |
8054892551
yuktis14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Postgraduate Institute of Medical Education and Research , Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Undergoing CABG/Valve replacement /repair procedure |
|
| ExclusionCriteria |
| Details |
Patients having contraindications to
1) insertion of TEE
2) weight <25 kg
3) having organic ds. Of tricuspid valve, tricuspid ring/prosthesis , more than Mild TR , Tricuspid annular calcification
4) Patient on pacemaker
5) having other than sinus heart rhythm
6 ) poor TTE window
7)pericardial disease
8) congenital shunt lesion
9) requiring inotropic/ vasopressor support prior to induction of anesthesia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Trans-tricuspid early (E) and late (A) diastolic velocities as well as E -wave deceleration
time (EDT) will be measured in A4C view by TTE and in Mid-esophageal right ventricular inflow-outflow view,
MEB view, DTRVIO
view by TEE.
Tricuspid annular early (e’) and late (a’) diastolic velocities as well as IVRT will be measured in A4C TTE and in MERVIO view,
TGRI view, Deep transgatric right ventricular
inflow outflow view by TEE |
single time point at baseline which is immediately after anesthesia induction. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To find out the transesophageal echocardiographic views having best
agreement with transthoracic echocardiography for measurement of individual Doppler and
Tissue Doppler velocities related to right ventricular diastolic function.
2. To find out the feasibility of measuring the right ventricular diastolic Doppler
and Tissue Doppler velocities using different views of transesophageal echocardiography. |
single time point at baseline which is immediately after anesthesia induction. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/02/2022 |
| Date of Study Completion (India) |
31/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/12/2022 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Quantitative assessment of right ventricle (RV) function is clinically valuable because RV function has prognostic significance in various cardiac and lung pathologies.Right Ventricle (RV) has a very important role in determining intraoperative and post operative outcomes of cardiopulmonary surgeries. Assessment of RV diastolic function can help in anticipating of post-operative complications after cardiopulmonary surgeries In a study, values of right ventricular systolic function by TEE have been shown to have only fair agreement to TTE measurements obtained in close temporal proximity under similar hemodynamic conditions Therefore, we intend to perform a study evaluating the agreement between transthoracic and transoesophageal echocardiography in measurement of right ventricular diastolic Doppler and tissue Doppler velocities in adult patients undergoing cardiac surgery. Based on the finding of our study, we can decide whether the right ventricular diastolic Doppler and tissue Doppler velocities measured by TEE can be used interchangeably with those measured by standard TTE
|