| CTRI Number |
CTRI/2025/11/097848 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
19/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
A European study to evaluate how doctors care for patients who get a heart ultrasound (called a transthoracic echocardiogram) before having surgery that doesn’t involve the heart, and what happens to those patients during that time. |
|
Scientific Title of Study
|
EuPreCHO: European study on perioperative management and outcome following Preoperative Transthoracic Echocardiography in noncardiac surgery patients. |
| Trial Acronym |
EuPreCHO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 4980_Version 1.0 dated 04.09.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Atul Kulkarni |
| Designation |
Professor and Head, Division of Critical Care Medicine |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anaesthesiology, Critical Care & Pain, Major OT Complex,
2nd floor Main Building
Tata Memorial Hospital Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869077526 |
| Fax |
|
| Email |
kaivalyaak@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul Kulkarni |
| Designation |
Professor and Head, Division of Critical Care Medicine |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anaesthesiology, Critical Care & Pain, Major OT Complex,
2nd floor Main Building
Tata Memorial Hospital Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869077526 |
| Fax |
|
| Email |
kaivalyaak@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Atul Kulkarni |
| Designation |
Professor and Head, Division of Critical Care Medicine |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anaesthesiology, Critical Care & Pain, Major OT Complex,
2nd floor Main Building
Tata Memorial Hospital Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869077526 |
| Fax |
|
| Email |
kaivalyaak@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital Dr E Borges Road Parel Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
European Society of Anaesthesiology and Intensive Care (ESAIC) |
| Address |
Rue des Comédiens 24, 1000 Brussels, Belgium |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Belgium
Germany
India
Sweden |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Atul Kulkarni |
Tata Memorial Centre |
Department of Anesthesia Critical care and Pain, Second floor, Major OT complex, Main Building, Tata Memorial Centre Dr E Borges Road Parel
Mumbai
MAHARASHTRA |
9869077526
kaivalyaak@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital Institutional Ethics Committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients planned to undergo elective, in-hospital intermediate or high-risk noncardiac surgery
procedures
2. aged more than or equal to 65 years OR
3. presenting more than or equal to 2 cardiovascular risk factors (hypertension, smoking, dyslipidaemia, diabetes,
family history of CVD) OR
4. with known cardiovascular disease |
|
| ExclusionCriteria |
| Details |
1. under 18 years of age
2. day surgery
3. urgent or emergency procedures
4. current ICU patient (i.e. in ICU on day-1 or the day of the index surgery (day 0)),
5. cardiac surgery within the last month prior to the index noncardiac procedure (of note this does not include cardiological interventions like TAVI or valvuloplasty),
6. unwilling or unable to provide informed consent,
7. unable to complete the WHODAS questionnaire (literacy or language barrier)
8. Previous enrollment in EuPreCHO (in case of repeated surgery). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Difference in current clinical practice with respect to the perioperative management of patients evaluated with vs those not evaluated with
preoperative TTE |
on Post operative day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Difference in current clinical practice with respect to the outcome of patients evaluated with vs those not evaluated with preoperative TTE |
on Post operative day 30 |
| Factors (model) which enhance the prediction of major pathologies in preoperative TTE |
on Post operative day 30 |
|
|
Target Sample Size
|
Total Sample Size="8089"
Sample Size from India="300"
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)
|
08/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/12/2025 |
| 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
|
According to current guidelines [1], a relevant proportion of European patients planned for
intermediate or high-risk noncardiac surgery procedure are supposed to undergo preoperative TTE.
The risk-benefit balance of this approach is unknown and may result in delayed surgery from limited
TTE availability and the inherent burdening of institutions without known clinical benefits.
Further, European anaesthesiologists are currently confronted with a guideline that they may not be
willing to implement due to knowledge gaps or not be able to implement due to logistical barriers.
Therefore, before considering reorganizing preoperative TTE logistics is an urgent need to generate
knowledge on the outcome impact of TTE prior to noncardiac surgery and to establish criteria that may
result in a more targeted use of preoperative TTE. |