Testing Automated Echocardiography

NCT ID: NCT04943965

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-11
• Study Completion Date: 2023-10-03

Brief Summary

The purpose of this research is to determine if software can accurately predict certain heart parameters from chest wall ultrasound (non-radiation, non-invasive, imaging modality). An approved ultrasound device (Lumify) will be used to obtain images prior to cardiac surgery.

Detailed Description

This is a prospective, non-randomized, single visit clinical study. No additional interventions or follow-ups to the subject will be conducted as part of the study. All investigational scanning will be conducted using the as low as reasonably achievable (ALARA) principle to ensure the safety of the subjects. As ultrasound imaging is based on non-ionizing radiation, it is generally considered safe when used by appropriately trained health care providers. The study population will be adults. There are no specific enrollment targets, however it is expected that 120 subjects or fewer will be scanned to obtain the required 40 echocardiographic exams to complete this study. Exceeding the enrollment target of 120 subjects will require an amendment to the protocol. It is estimated this study will last for 12 months, at that time it will be evaluated and may potentially be amended.

This study is considered non-significant risk. There is no specific benefit to individuals participating in the study, however the feedback received is used to improve Philips systems and that can lead to increased diagnostic ability in future products.

Conditions

This Study is Being Conducted to Collect Echocardiographic Data to Test the Lumify Ultrasound With Hemodynamic Automation Device

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient undergoing a cardiac surgery

Patients undergoing cardiac surgeries listed in inclusion criteria will be in this group.

Ultrasound imaging

Intervention Type: DIAGNOSTIC_TEST

The intervention is non-invasive, chest wall, echocardiographic image acquisition in the cardiac operating room prior to a scheduled cardiac surgery. Echocardiographic images will be taken at three, key, timepoints in the operating room prior to cardiac surgery:

1. Pre-induction.

2. Post-induction / Pre-PAC

3. Post-induction / Post-PAC

Clinicians

Clinicians defined as physicians (e.g. attendings, fellows, residents) or advanced practice providers (e.g. nurse practitioners and physician assistants) will be in this group.

No interventions assigned to this group

Interventions

Ultrasound imaging

The intervention is non-invasive, chest wall, echocardiographic image acquisition in the cardiac operating room prior to a scheduled cardiac surgery. Echocardiographic images will be taken at three, key, timepoints in the operating room prior to cardiac surgery:

1. Pre-induction.

2. Post-induction / Pre-PAC

3. Post-induction / Post-PAC

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Philips Ultrasound; Lumify Ultrasound; Hemodynamic Automation device

Eligibility Criteria

Inclusion Criteria

• Patient willing and capable of providing informed consent and physically capable of performing study related activities
• Patient undergoing any of the following types of cardiac surgeries:

Aortic valve repair Aortic valve replacement Mitral valve repair Mitral valve replacement Tricuspid valve repair Tricuspid valve replacement Pulmonic valve repair Pulmonic valve replacement Ascending aorta replacement Coronary Artery Bypass Graft (CABG) surgery

Exclusion Criteria

• Pregnant women
• Patients known to be under the jurisdiction of the Department of Corrections
• Patients with persistent arrhythmias as confirmed by the principal investigator (MacKay) on a caseby-case basis (e.g. atrial fibrillation, atrial flutter, frequent premature ventricular contractions, frequent premature atrial contractions, etc.)
• Patients with a contraindication to Pulmonary Arterial Catheter (PAC) monitoring as confirmed by the principal investigator (MacKay) on a case-by-case basis (e.g. tricuspid or pulmonic valve endocarditis, venous thrombosis present in the superior vena cava, right atrium, or main pulmonary artery)
• Patients with a contraindication to TEE monitoring as confirmed by the principal investigator (MacKay) on a case-by-case basis (e.g. previous esophageal surgery, prior gastric bypass surgery, esophageal varices).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Medical Systems

INDUSTRY

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Emily MacKay, DO, MSHP

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roderic G Eckenhoff, MD

Role: STUDY_CHAIR

University of Pennsylvania, Department of Anesthesiology and Critical Care

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

848896

Identifier Type: -

Identifier Source: org_study_id