Intraoperative Echocardiography in Low-Risk CABG Surgery

NCT ID: NCT06154265

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-22
• Study Completion Date: 2025-12-31

Brief Summary

This goal of this study is to better understand when and where intraoperative transesophageal echocardiography (TEE) should (or should not) be used during coronary artery bypass graft (CABG) surgeries.

Detailed Description

This trial will look at benefits and harms to two different treatments strategies in order to improve clinical outcomes. Intraoperative TEE is an ultrasound-based, imaging device that uses sound valves to look at the heart continuously during a heart surgery.

Conditions

Heart Diseases; Coronary Artery Disease; Chest Pain; Stenosis Coronary; STEMI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Default TEE

The TEE probe is placed after going under general anesthesia and a breathing tube is placed. TEE issued to take pictures of the heart before and after a CABG surgery. If randomized to this group, the TEE probe will remain in place throughout the surgery.

Group Type: ACTIVE_COMPARATOR

TEE probe

Intervention Type: DEVICE

Transesophageal echocardiography, ultrasound probe

As-needed TEE

The TEE probe is placed only in situations where a surgeon requires information that can only be obtained by ultrasound imaging of the heart.

Group Type: OTHER

TEE probe

Intervention Type: DEVICE

Transesophageal echocardiography, ultrasound probe

Interventions

TEE probe

Transesophageal echocardiography, ultrasound probe

Intervention Type: DEVICE

Other Intervention Names

Philips transesophageal echocardiography (TEE), ultrasound probe

Eligibility Criteria

Inclusion Criteria

1. Scheduled to undergo isolated CABG surgery at a hospital within the UPenn Health System

2. Age ≥18 years

3. Ejection fraction ≥50%

4. Transthoracic echocardiography within one year of scheduled surgery date

5. Left heart catheterization within one year of scheduled surgery date

6. English language fluency or facilitated via language interpreter

7. Able to provide informed consent either in English or via a language interpreter

8. Willing to comply with all study procedures

Exclusion Criteria

1. Documented valve (aortic, mitral, tricuspid, or pulmonic) disease (stenosis or regurgitation) moderate or greater.

2. Any CABG surgery with either "possible" or "definite" aortic intervention listed as a planned part of the procedure. plan for either definite or possible surgical intervention.

3. Any CABG surgery with either "possible" or "definite" valve repair/replacement listed as a planned part of the procedure.

4. Having undergone any previous cardiac surgeries (i.e. scheduled with a "REDO" modifier).

5. Proximal/critical left main coronary disease (e.g. greater than or equal to 90% stenosis).

6. Preexisting anomalous coronary arteries

7. Preexisting end-stage renal disease on hemodialysis

8. Preexisting chronic kidney disease (CKD) stage 3, 4, or 5

9. Stroke with residual focal neurological deficit(s) within 90 days of surgery

10. Any of the following presurgical, mechanical circulatory support devices:

1. Intraaortic balloon pump

2. Percutaneous right ventricular assist device (RVAD)

3. Impella

4. Extracorporeal membrane oxygenation (ECMO)

11. Absolute contraindication to echocardiography defined as one or more of the following documented conditions:

1. Esophagectomy

2. Esophagogastrectomy

3. Esophageal trauma

12. Any of these three relative contraindication to TEE:

1. Esophageal varies

2. Gastric bypass surgery

3. Descending thoracic aortic aneurysm

13. Severe pulmonary hypertension defined as:

1. Pulmonary arterial pressure ≥60 mmHg

2. Pulmonary vascular resistance (PVR) ≥3 Woods Units

14. Hemodynamic instability after induction and following placement of an endotracheal tube will be defined as one or more of the following events or scenarios:

1. Placement of an intraaortic balloon pump (IABP)

2. Initiation of venoarterial extracorporeal membrane oxygenation (VAECMO)

3. Placement of a right or left percutaneous mechanical circulatory support device

4. Initiation of epinephrine infusion at a dose ≥ 6 mcg/min for a duration ≥5 minutes

5. Initiation of norepinephrine at a dose ≥8 mcg/min for a duration ≥ minutes

6. Initiation of phenylephrine infusion at a dose ≥100 mcg/min for a duration ≥ minutes

7. Initiation of vasopressin infusion at a dose ≥0.04 units/min for a duration ≥ minutes

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily MacKay, DO, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania, Penn Medicine

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

853364

Identifier Type: -

Identifier Source: org_study_id