Status:
ACTIVE_NOT_RECRUITING
Intraoperative Echocardiography in Low-Risk CABG Surgery
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Heart Diseases
Coronary Artery Disease
Eligibility:
All Genders
18-100 years
Phase:
NA
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 valve...
Eligibility Criteria
Inclusion
- Scheduled to undergo isolated CABG surgery at a hospital within the UPenn Health System
- Age ≥18 years
- Ejection fraction ≥50%
- Transthoracic echocardiography within one year of scheduled surgery date
- Left heart catheterization within one year of scheduled surgery date
- English language fluency or facilitated via language interpreter
- Able to provide informed consent either in English or via a language interpreter
- Willing to comply with all study procedures
Exclusion
- 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.
- Having undergone any previous cardiac surgeries (i.e. scheduled with a "REDO" modifier).
- Proximal/critical left main coronary disease (e.g. greater than or equal to 90% stenosis).
- Preexisting anomalous coronary arteries
- Preexisting end-stage renal disease on hemodialysis
- Preexisting chronic kidney disease (CKD) stage 3, 4, or 5
- Stroke with residual focal neurological deficit(s) within 90 days of surgery
- Any of the following presurgical, mechanical circulatory support devices:
- Intraaortic balloon pump
- Percutaneous right ventricular assist device (RVAD)
- Impella
- Extracorporeal membrane oxygenation (ECMO)
- 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
Key Trial Info
Start Date :
January 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06154265
Start Date
January 22 2024
End Date
December 31 2025
Last Update
July 11 2025
Active Locations (1)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104