40 Participants Needed

Intraoperative Echocardiography for Heart Disease

EM
Overseen ByEmily MacKay, DO
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for guidance.

Is intraoperative echocardiography safe for use in humans?

Intraoperative echocardiography is widely used in cardiac surgeries and is considered a valuable tool for monitoring and decision-making during operations. It has been reported to have a positive impact on patient outcomes, and no specific safety concerns have been highlighted in the available research.12345

How is intraoperative echocardiography different from other treatments for heart disease?

Intraoperative echocardiography is unique because it allows surgeons to see the heart in real-time during surgery, helping them to better understand the heart's structure and function, and to immediately evaluate the success of the surgery. This real-time imaging is not possible with other treatments, making it a valuable tool for improving surgical outcomes.23467

What data supports the effectiveness of the treatment Intraoperative Echocardiography for Heart Disease?

Intraoperative echocardiography is shown to be effective in improving surgical outcomes by allowing surgeons to see the heart in action, assess heart function, and make immediate decisions during surgery. It is particularly useful in high-risk heart surgeries, such as coronary artery bypass grafting, and helps in diagnosing and managing complications during procedures.348910

Who Is on the Research Team?

EM

Emily MacKay, DO, MS

Principal Investigator

University of Pennsylvania, Penn Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are scheduled for low-risk isolated CABG surgery, have a good heart pump function (ejection fraction ≥50%), and recent heart tests. It's not for those with moderate or severe valve disease, planned aortic interventions, critical coronary disease, end-stage kidney disease on dialysis, certain esophageal conditions, or severe pulmonary hypertension.

Inclusion Criteria

Ejection fraction ≥50%
English language fluency
I am scheduled for a heart bypass surgery at PPMC.
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Exclusion Criteria

Severe pulmonary hypertension defined as: Pulmonary arterial pressure ≥60 mmHg, Pulmonary vascular resistance (PVR) ≥3 Woods Units
I have moderate or severe heart valve disease.
I have had severe heart or blood pressure issues after a specific medical procedure.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo coronary artery bypass graft (CABG) surgery with either default or as-needed intraoperative transesophageal echocardiography (TEE)

During surgery

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessment of gastroesophageal and end-organ dysfunction, and incidence of cardiovascular re-intervention or mortality

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Intraoperative Echocardiography
Trial Overview The study aims to determine the usefulness of using an intraoperative TEE probe during CABG surgeries. The TEE probe is used to take detailed images of the heart from inside the esophagus during surgery to guide decisions and improve outcomes.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: As-needed TEEExperimental Treatment1 Intervention
The TEE probe is placed only in situations where a surgeon requires information that can only be obtained by ultrasound imaging of the heart.
Group II: Default TEEActive Control1 Intervention
The TEE probe is placed after going under general anesthesia and a breathing tube is placed. TEE issued to take pictures of the heart before and after a CABG surgery. If randomized to this group, the TEE probe will remain in place throughout the surgery.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Citations

Intraoperative echocardiography: techniques and current applications. [2019]
Intraoperative echocardiography is indicated in high-risk coronary artery bypass grafting. [2016]
[Aortic dissection after mitral valve replacement: the role of intraoperative echocardiography in the diagnosis]. [2022]
Intraoperative echocardiographic assessment of global and regional myocardial function. [2019]
Intraoperative transesophageal echocardiography with a special focus on a patient undergoing advanced robotic-assisted procedures. [2019]
[Intraoperative echocardiography: impact on surgical decision-making]. [2021]
Intraoperative echocardiography: support for decision making in cardiac surgery. [2017]
Role of intraoperative transesophageal echocardiography in patients undergoing noncardiac surgery. [2016]
Improved surgical approach to cardiac tumors with intraoperative two-dimensional echocardiography. [2019]
Intraoperative echocardiography. [2019]
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