Intraoperative Echocardiography in Low-Risk CABG Surgery

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06154265
• Other study ID #: 853364
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: January 31, 2027

Study information

• Verified date: May 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: January 31, 2027
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chest Pain
• Coronary Artery Disease
• Coronary Stenosis
• Heart Diseases
• STEMI

Intervention

Device:
• TEE probe
Transesophageal echocardiography, ultrasound probe

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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