Intraoperative Echocardiography in Low-Risk CABG Surgery

Sponsor

University of Pennsylvania (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06154265

Collaborator

National Institutes of Health (NIH) (NIH)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Diseases Coronary Artery Disease Chest Pain Stenosis Coronary STEMI	Device: TEE probe	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

(1) Default TEE: Where the TEE probe is placed after going under general anesthesia and a breathing tube is placed. TEE issued to take pictures of your heart before and after the CABG surgery. The TEE probe will remain in place throughout the surgery. (2) As-Needed TEE: Where the TEE probe is placed only in situations where a surgeon requires information that can only be obtained by ultrasound imaging of the heart.(1) Default TEE: Where the TEE probe is placed after going under general anesthesia and a breathing tube is placed. TEE issued to take pictures of your heart before and after the CABG surgery. The TEE probe will remain in place throughout the surgery. (2) As-Needed TEE: Where the TEE probe is placed only in situations where a surgeon requires information that can only be obtained by ultrasound imaging of the heart.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Default vs As-Needed Intraoperative Transesophageal Echocardiography (TEE) in Low-Risk Isolated Coronary Artery Bypass Graft (CABG) Surgery: A Randomized Controlled Trial

Anticipated Study Start Date :

Feb 1, 2024

Anticipated Primary Completion Date :

Jan 31, 2026

Anticipated Study Completion Date :

Jan 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Device: TEE probe Transesophageal echocardiography, ultrasound probe Other Names: Philips transesophageal echocardiography (TEE), ultrasound probe
Other: 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.	Device: TEE probe Transesophageal echocardiography, ultrasound probe Other Names: Philips transesophageal echocardiography (TEE), ultrasound probe

Arm

Intervention/Treatment

Active Comparator: 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.

Device: TEE probe

Transesophageal echocardiography, ultrasound probe

Other Names:

Philips transesophageal echocardiography (TEE), ultrasound probe

Other: 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.

Device: TEE probe

Transesophageal echocardiography, ultrasound probe

Other Names:

Philips transesophageal echocardiography (TEE), ultrasound probe

Outcome Measures

Primary Outcome Measures

Primary Objectives [24 months]
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. Assess intervention fidelity by calculating the rate of TEE performed among participants randomized to the as-needed TEE trial arm.

Secondary Outcome Measures

Secondary Objectives [24 month]
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. 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.). 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]). Incidence of all-cause in-hospital mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Scheduled to undergo isolated CABG surgery at PPMC
Age ≥18 years
Ejection fraction ≥50%
Transthoracic echocardiography within 90 days of surgery
Left heart catheterization within 90 days of surgery
English language fluency
Able to provide informed consent.

Exclusion Criteria:

Documented valve (aortic, mitral, tricuspid, or pulmonic) disease (stenosis or regurgitation) moderate or greater.
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.
Any CABG surgery with either "possible" or "definite" valve repair/replacement listed as a planned part of the procedure.
Proximal/critical left main coronary disease (e.g. 90% stenosis).
Preexisting end-stage renal disease on hemodialysis
Absolute contraindication to echocardiography defined as one or more of the following documented conditions:
Esophagectomy
Esophagogastrectomy
Esophageal trauma
Any of these three relative contraindication to TEE:
Esophageal varies
Gastric bypass surgery
Descending thoracic aortic aneurysm
Severe pulmonary hypertension defined as:
Pulmonary arterial pressure ≥60 mmHg
Pulmonary vascular resistance (PVR) ≥3 Woods Units
Hemodynamic instability after induction and following placement of an endotracheal tube will be defined as one or more of the following events or scenarios:
Placement of an intraaortic balloon pump (IABP)
Initiation of venoarterial extracorporeal membrane oxygenation (VAECMO)
Placement of a right or left percutaneous mechanical circulatory support device
Initiation of epinephrine infusion at a dose ≥ 6 mcg/min for a duration ≥5 minutes
Initiation of norepinephrine at a dose ≥8 mcg/min for a duration ≥ minutes
Initiation of phenylephrine infusion at a dose ≥100 mcg/min for a duration ≥ minutes
Initiation of vasopressin infusion at a dose ≥0.04 units/min for a duration ≥ minutes