Clinical trial NCT06154265: Intraoperative Echocardiography in Low-Risk CABG Surgery
Official title: Default vs As-Needed Intraoperative Transesophageal Echocardiography (TEE) in Low-Risk Isolated Coronary Artery Bypass Graft (CABG) Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Diseases
Coronary Artery Disease
Chest Pain
Stenosis Coronary
STEMI
Keywords: Heart
Chest Pain
Artery
Stenosis
TEE
CABG
Bypass
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2023-12-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Primary Objectives
timeFrame: 24 months
Secondary outcomes:
measure: Secondary Objectives
timeFrame: 24 month
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania, Penn Medicine
name: Emily MacKay, DO, MS
role: PRINCIPAL_INVESTIGATOR
References: