Clinical trial NCT03897140: Point-of-Care Echocardiography With Assistance Technology
Official title: Study for Point-of-Care Echocardiography With Assistance Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Disease
Lead sponsor: Caption Health, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-01
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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).

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Study-level Assessment
timeFrame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Secondary outcomes:
measure: View-level Assessment
timeFrame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
measure: Inter-User Variability (Primary Clinical Parameters)
timeFrame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
measure: Inter-User Variability (Acquisition Time)
timeFrame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
measure: Patient-Level Acquisition time
timeFrame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
measure: View-Level Acquisition time
timeFrame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
measure: Comparison of study exam and control exam (View-Level Results)
timeFrame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
measure: Comparison of study exam and control exam (Patient-Level Results)
timeFrame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
measure: Comparison of study exam and control exam (Task-Based Assessment)
timeFrame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine, Bluhm Cardiovascular Institute
state: Illinois
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
Study officials:
affiliation: Northwestern Medicine, Bluhm Cardiovascular Institute
name: Akhil Narang, MD
role: PRINCIPAL_INVESTIGATOR
References: