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Completed

NCT Number: NCT06154265

Intraoperative Echocardiography in Low-Risk CABG Surgery

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.

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Key information

About this study

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 waves to look at the heart continuously during a heart surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TEE probe

Device

Transesophageal echocardiography, ultrasound probe

Other names: Philips transesophageal echocardiography (TEE), ultrasound probe

Primary outcomes

  1. Enrollment and Randomization Feasibility

    Time frame: At time of enrollment and randomization (baseline)

    Enrollment and randomization feasibility defined as the proportion of patients approached for enrollment who consented and were successfully randomized. Of 72 patients approached for enrollment, 40 were randomized.

Secondary outcomes

  1. Protocol Adherence

    Time frame: During index surgical procedure (from induction of anesthesia to completion of surgery; typical duration approximately 5-8 hours)

    Protocol adherence defined as receipt of the intraoperative transesophageal echocardiography strategy corresponding to randomized assignment.

  2. Rescue Echocardiography Use in the Backup TEE Arm

    Time frame: During index surgical procedure (from induction of anesthesia to completion of surgery; typical duration approximately 5-8 hours)

    Use of rescue transesophageal echocardiography among participants randomized to the Backup TEE strategy, defined as intraoperative TEE performed in response to a clinical indication per protocol. Of 20 participants randomized to Backup TEE, 3 (15%) received rescue TEE.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 4, 2023
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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