Point-of-Care Echocardiography With Assistance Technology

Study for Point-of-Care Echocardiography With Assistance Technology

Establish the effectiveness of the Bay Labs, Inc. EchoGPS software in enabling RNs to acquire echocardiograms. In this study an echocardiogram protocol using the EchoGPS interface with the Terason uSmart 3200t, an FDA 510(k)-cleared, commercially available ultrasound device will be performed. Participants will have two scans, one by a registered nurse (RN) using the Terason uSmart 3200t with EchoGPS (Study Exam) and one by a sonographer using the Reference Device without EchoGPS guidance (Control Exam), under the same protocol. Study is non-significant risk (NSR).

To validate clinical use of Bay Labs, Inc. EchoGPS guidance software by registered nurses (RNs) with no prior scanning experience to acquire limited two-dimensional echocardiograms. In this study an echocardiogram protocol using the EchoGPS interface with the Terason uSmart 3200t, an FDA 510(k)-cleared, commercially available ultrasound device will be performed. Participants will have two scans, one by a registered nurse (RN) using the Terason uSmart 3200t with EchoGPS (Study Exam) and one by a sonographer using the Reference Device without EchoGPS guidance (Control Exam), under the same protocol. Study is non-significant risk (NSR).

Inclusion Criteria:

All patients must meet the following inclusion criteria to participate in the study:

• Patients scheduled for an echocardiographic examination
• Patients ≥18 years old

Exclusion Criteria:

Patients must NOT meet any of the following exclusion criteria to participate in the trial:

• Unable to lie flat for study
• Patients experiencing a known or suspected acute cardiac event
• Patients with severe chest wall abnormalities
• Patients who have undergone pneumonectomy
• Patients unwilling or unable to give written informed consent