Intraoperative Echocardiography in Low-Risk CABG Surgery

Not Applicable

Active, not recruiting

• Conditions: Heart Diseases; Chest Pain; Coronary Artery Disease; STEMI; Stenosis Coronary
• Interventions: Device: TEE probe

• Registration Number: NCT06154265
• Lead Sponsor: University of Pennsylvania

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.

Study Timeline

• Study First Submitted: 2023-11-13
• Study First Submitted QC: 2023-11-30
• Study First Posted: 2023-12-04
• Study Start: 2024-01-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
As-needed TEE	TEE probe	The TEE probe is placed only in situations where a surgeon requires information that can only be obtained by ultrasound imaging of the heart.
Default TEE	TEE probe	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.

Primary Outcome Measures

Name	Time	Method
Primary Objectives	24 months	1. Recruitment feasibility assessment as measured by an absolute recruitment rate. Absolute recruitment rate is defined as the number of successfully enrolled participants divided by the total number of screened participants.; 2. Assess intervention fidelity by calculating the rate of TEE performed among participants randomized to the as-needed TEE trial arm.

Secondary Outcome Measures

Name	Time	Method
Secondary Objectives	24 month	1. Evidence of clinically-significant gastroesophageal dysfunction during hospitalization - either by patient-reported symptoms or by the presence of testing for swallowing difficulty, dysfunction, or upper endoscopy diagnostic procedures.; 2. Evidence of end-organ dysfunction based on clinical notes (e.g. "transaminitis," "acute kidney/renal injury"), and/or laboratory-based evidence of (e.g. liver function tests \[LFTs\], serum creatinine \[Cr\], lactate, etc.).; 3. Incidence of in-hospital, post-surgical, cardiovascular re-intervention (e.g. return to the operating room for any reason, unplanned or emergency cardiac catheterization post-surgery, or placement on venoarterial extracorporeal membrane oxygenation \[VAECMO\]).; 4. Incidence of all-cause in-hospital mortality

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States