Intraoperative Echocardiography in Low-Risk CABG Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Diseases, Coronary Artery Disease, Chest Pain, Stenosis Coronary, STEMI

Intervention / Treatment
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* Device: TEE probe


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Default TEE<br>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<br>* Transesophageal echocardiography, ultrasound probe<br>* Other names: Philips transesophageal echocardiography (TEE), ultrasound probe;|
| Other: As-needed TEE<br>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<br>* Transesophageal echocardiography, ultrasound probe<br>* Other names: Philips transesophageal echocardiography (TEE), ultrasound probe;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Objectives | 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. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Objectives | 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 | 24 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart, Chest Pain, Artery, Stenosis, TEE, CABG, Bypass