N/A
N=40
Intraoperative Echocardiography in Low-Risk CABG Surgery
Heart Diseases · Coronary Artery Disease · Chest Pain · Stenosis Coronary · STEMI
Bottom Line
View on ClinicalTrials.gov: NCT06154265 ↗Enrolled (actual)
40
Serious AEs
7.5%
Results posted
May 2026
Primary outcome: Primary: Enrollment and Randomization Feasibility — 40 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TEE probe (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Enrollment and Randomization Feasibility |
40 | — |
| SECONDARY Protocol Adherence |
19; 20 | — |
| SECONDARY Rescue Echocardiography Use in the Backup TEE Arm |
3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 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.
- 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
Data sourced from ClinicalTrials.gov (NCT06154265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.