| CTRI Number |
CTRI/2023/09/058130 [Registered on: 29/09/2023] Trial Registered Prospectively |
| Last Modified On: |
28/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Study of Transthoracic Echocardioraphy and Transesophageal Echocardiography |
|
Scientific Title of Study
|
A Non Inferiority study of transthoracic echocardiography and transesophageal echocardiography for assessment of grading of aortic stenosis in adult patients undergoing elective aortic valve replacement surgeries under general anaesthesisa at SMS Medical college, Jaipur during 2022-2024 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjum Saiyed |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical college and attached Hospitals, Jaipur |
| Address |
Department of Anesthesiology SMS Medical College and attached Hospitals Adarsh Nagar Jaipur Rajasthan 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9214021930 |
| Fax |
|
| Email |
Dranjumsaiyed@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjum Saiyed |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical college and attached Hospitals, Jaipur |
| Address |
Department of Anesthesiology SMS Medical College and attached Hospitals Adarsh Nagar Jaipur Rajasthan 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9214021930 |
| Fax |
|
| Email |
Dranjumsaiyed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gulam Moinuddin |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical college and attached Hospitals, Jaipur |
| Address |
Department of Anesthesiology SMS Medical College and attached Hospitals Adarsh Nagar Jaipur Rajasthan 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9983382262 |
| Fax |
|
| Email |
monuwont13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology SMS Medical College and attached Hospitals jaipur |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology SMS Medical College and attached Hospitals Jaipur |
| Address |
JLN Marg, Adarsh Nagar, Jaipur |
| Type of Sponsor |
Government medical college |
|
|
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 Gulam Moinuddin |
S.M.S Medical College and attached Hospital Jaipur |
Cardiac surgery operation theatres on 2nd floor of Bangad Parisar s.m.s. medical
college and attached Hospitals JLM marg, Adarsh Nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN |
9983382262
monuwont13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Ethics committee, S.M.S. Medical college and Attached Hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: I350||Nonrheumatic aortic (valve) stenosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Transesophageal Echocardiography Probe |
Non Inferiority study of Transthoracic Echocardiography and Transesophageal Echocardiography for Assesment of Grading of Aortic Stenosis in Adult patient undergoing Elective Aortic Valve Replacement surgeries under Genral Anesthesia (after induction of anaesthesia) |
| Comparator Agent |
Transthoracic Echocardiography Probe |
Non Inferiority study of Transthoracic Echocardiography and Transesophageal Echocardiography for assesment of Grading of Aortic Stenosis in Adult patient undergoing Elective Aortic Valve Replacement surgeries under Genral Anesthesia (before induction of anaesthesia) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient willing to give consent
2)Patient undergoing elective surgery for Aortic Valve Replacement in Moderate to Severe Aortic Stenosis
3)Patient belonging to ASA grade3 and grade4
4)BMI<30 |
|
| ExclusionCriteria |
| Details |
1)Patient not willing to participate in study
2)Moderate to Severe AR(aortic regurgitation)
3)Patient of MR(mitral regurgitation)
4)Double valve diseases
5)Mild AS(aortic stenosis)
6)Hemodynamic Instability
7)If there is echo probe related contraindication during introducing tee probe |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)peak jet velocity(m/s)
2)mean gradient(mmHg)
3)aortic valve area(cm2)
4)Dimentionless index
|
1)before induction
2)after induction
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic variables(Pulse,SBP, DBP,MAP) |
before and after induction |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
08/10/2023 |
| 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)
|
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
|
Echocardiography are routine investigation in cardiac patients which is routinely done by transthoracic probe and sometime by transesophageal probes also. The parameter of aortic valve like peak jet velocity, mean gradient, aortic valve area and dimentionless index vary with the method which are using for the diagnosis |