| CTRI Number |
CTRI/2025/03/081679 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
23/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How Anesthesiologists Use Artificial Intelligence to Check Heart Health Before Surgery: A Multi-Center Study" |
|
Scientific Title of Study
|
Preoperative Echocardiography Evaluation with Artificial Intelligence Algorithm by Anesthesiologists: Prospective Observational Multicenter Study. |
| 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 Deepak Borde |
| Designation |
Consultant, CArdiac Anesthesia |
| Affiliation |
Ozone Anesthesia Group |
| Address |
First Floor OPD Wing, United CIIGMA Hospital, Shahnoorwadi, Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7350357108 |
| Fax |
|
| Email |
deepakborde2482@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Borde |
| Designation |
Consultant, CArdiac Anesthesia |
| Affiliation |
Ozone Anesthesia Group |
| Address |
First Floor OPD Wing, United CIIGMA Hospital, Shahnoorwadi, Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7350357108 |
| Fax |
|
| Email |
deepakborde2482@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Borde |
| Designation |
Consultant, CArdiac Anesthesia |
| Affiliation |
Ozone Anesthesia Group |
| Address |
First Floor OPD Wing, United CIIGMA Hospital, Shahnoorwadi, Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7350357108 |
| Fax |
|
| Email |
deepakborde2482@gmail.com |
|
|
Source of Monetary or Material Support
|
| NIL |
| United CIIGMA Hospital, Shahnoorwadi, Aurangabad, Maharashtra, India 431001. |
|
|
Primary Sponsor
|
| Name |
United CIIGMA Hospital |
| Address |
Shahnoorwadi, Aurangabad, Maharashtra,India 431001 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amish Jasapara |
Fortis Hospitals |
Mulund - Goregaon Link Rd, Nahur West, Industrial Area, Bhandup West, Mumbai,
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
9820699915
amish.jasapara@gmail.com |
| Dr Samrat Madanaik |
Krishna Vishwa Vidyapeeth |
NH4, Pune - Bangalore Highway, Agashivnagar, Malkapur,
Satara
Satara
MAHARASHTRA |
8660976724
samratmadanaik@gmail.com |
| Dr Kumar C |
Madras Medical Mission |
4-A, Dr, Mogappair, Chennai,
Chennai
Chennai
TAMIL NADU |
9842296410
vairam100596@gmail.com |
| Dr Shreedhar Joshi |
Narayana Health |
258/A, Bommansendra Industrial Area, Hosur
Bangalore
Bangalore
KARNATAKA |
9740067381
shreedhar.8181@gmail.com |
| Dr Amit Dixit |
Ruby Hall Clinic |
40, Sasson Road, Pune
Pune
Pune
MAHARASHTRA |
7387584339
drdixitamit@gmail.com |
| Dr Deepak Borde |
United CIIGMA Hospital |
Shahnoorwadi, Aurangabad
Aurangabad
MAHARASHTRA |
7350357108
deepakborde2482@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE KODLIKERI MEMORIAL HOSPITAL (K. M. H.) GROUP Of CIGMA HOSPITAL (G.C.H.) |
Approved |
| FORIS HOSPITAL MUMBAI |
Approved |
| KRISHNA VISWA VIDYAPEETH |
Approved |
| Madras Medical Misssion |
Approved |
| Narayana Health Academic Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients (male or non-pregnant female) referred from the pre-anaesthetic clinic / pre-anaesthetic evaluation for 2D echocardiography as a part of preoperative workup before surgery.
· Ability to complete a clinical echocardiogram on the same day before or after study procedures
· Able and willing to provide informed consent
· Outpatients and inpatients being evaluated before elective surgery
|
|
| ExclusionCriteria |
| Details |
Patients with insufficient-quality echo images.
· Unwilling or unable to provide informed consent
· Patients admitted to ICU on mechanical ventilator support and on vasoactive medications to maintain stable hemodynamics. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary endpoint of the study will be the diagnostic accuracy of the following parameters obtained by US2.AI software compared to these measurements by echocardiography machine performed by clinician:
1. LV Size
2. LV Systolic Function
3. LV Diastolic Function
4. RV Size
5. RV Function
6. LA Size
7. RA Size
8. IVC Diameter and Collapsibility
9. Aortic Valve
10. Cardiac Output
|
At Baseline
Before Surgery in Pre Anesthesia Clinic |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/03/2025 |
| Date of Study Completion (India) |
01/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
aa |