| CTRI Number |
CTRI/2024/11/077245 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective longitudinal |
| Study Design |
Other |
|
Public Title of Study
|
Measurement of power of heart by echocardiography in adult patients undergoing heart bypass surgery at different time points around surgery |
|
Scientific Title of Study
|
Serial changes of echocardiography derived cardiac power output over the perioperative period in adult patients undergoing CABG: a prospective, observational 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 |
Sahithya K |
| Designation |
Junior Resident |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8056744760 |
| Fax |
|
| Email |
sahithya7597@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indranil Biswas |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, PGIMER, Chandigarh
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, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7710449858 |
| Fax |
|
| Email |
hreesheekombartta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cardiac centre, PGIMER, sector 12, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, 4th floor, Block A, Nehru hospital, Post Graduate Institute of Medical Education and Research, Chandigarh 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 |
| Sahithya K |
PGIMER, Chandigarh |
Room 4016, 4th floor, Advanced Cardiac Centre, Post Graduate Institute of Medical Education and Research, sector 12, Chandigarh
Chandigarh
CHANDIGARH |
8056744760
sahithya7597@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh Institutional Ethics Committee (Intramural) |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of either gender and between 20 and 60 years of age undergoing more than or equal to two grafts coronary artery bypass grafting surgery |
|
| ExclusionCriteria |
| Details |
1. Declined consent
2. Concomitant moderate/severe valvular heart disease
3. Patients not with sinus rhythm at the time of performing TEE/TTE.
4. Patients on Pacemaker.
5. Contraindications to transesophageal echocardiography
6. Patients with poor TTE window
7. Re-operative/emergency surgery
8. Significant non-cardiac organ disease
9. Inotropic/mechanical support prior to induction of anaesthesia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Measurement of echocardiography derived cardiac power output (CPO) serially at different time-points of perioperative period and compare in between the time-points in patients undergoing coronary artery bypass grafting |
Before induction of anaesthesia and after induction of anaesthesia; immediately after surgery and postoperative day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Measurement of echocardiography derived cardiac power index (CPI) and stroke output serially at different time-points of perioperative period and compare in between the time-points (Before induction of anaesthesia and after induction of anaesthesia; immediately after surgery and postoperative day 7) in patients undergoing coronary artery bypass grafting
• To assess relation between the changes in CPO, CPI and stroke output values from before induction to after induction of anaesthesia time points and that from immediately after surgery to postoperative day 7 time points with the age, EuroScore, pre-induction ejection fraction (LVEF) and pre-induction peak LV global longitudinal strain of the patients undergoing coronary artery bypass grafting
|
Before induction of anaesthesia and after induction of anaesthesia; immediately after surgery and postoperative day 7 |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
02/12/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is a prospective, observational study. The primary objective of the study is to serially measure echocardiography derived cardiac power output during various time points in patients undergoing elective coronary artery bypass graft surgery. Patients are screened for inclusion criteria during preop evaluation and if they meet the criteria of inclusion and exclusion, they are explained about the study and its risk- benefits. Written informed consent is obtained. In the OT, echocardiography is used to obtain cardiac power output before and after induction of anaesthesia, before shifting the patient to ICU and on POD 7. A total of 54 patients are considered to be taken up for the study and conclusion will be drawn after statistical analysis. |