Point-of-Care Echocardiography With Assistance Technology

Cardiac Disease Clinical Trial

Official title:

Study for Point-of-Care Echocardiography With Assistance Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03897140
• Other study ID #: EchoGPSPivotal1.0
• Status: Completed
• Phase: N/A
• Start date: March 25, 2019
• Est. completion date: May 23, 2019

Study information

• Verified date: September 2019
• Source: Bay Labs, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: May 23, 2019
• Est. primary completion date: May 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

Diagnostic Test:
• Diagnostic Test: Limited Echocardiogram
STUDY SOFTWARE non-significant risk (NSR) Bay Labs EchoGPS software interfaced with the Terason uSmart 3200t FDA 510(k)-cleared, commercially available ultrasound EchoGPS software communicates with the ultrasound image formation engine of the 510(k)-cleared Terason uSmart 3200t through an application programming interface (API). EchoGPS will be used to provide visual guidance feedback to users during image acquisition. For this study, RNs will use EchoGPS to perform limited echocardiogram examinations.

Locations

Country	Name	City	State
United States	Northwestern Medicine, Bluhm Cardiovascular Institute	Chicago	Illinois
United States	Minneapolis Heart Institute	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Sara Guttas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study-level Assessment	The primary endpoints for the study are separate patient-level assessments of whether the patient study is of adequate image quality to make a qualitative visual assessment for a particular clinical parameter (ie., Yes/No). Expert cardiologist readers will independently provide assessments and they will be blinded to the assessments from the other readers as well as whether the images were acquired by an RN or sonographer.; The Outcome Measure will be reported as the percentage of patient studies for which the panel of cardiologist readers adjudicated as being of sufficient image quality to make a particular clinical assessment.	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Secondary	View-level Assessment	The Outcome Measure will be reported as the percentage of patient studies with diagnostic quality clip for a particular Standard View acquired in the study. Expert cardiologist readers will independently provide assessments and they will be blinded to the assessments from the other readers as well as whether the images were acquired by an RN or sonographer.	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Secondary	Inter-User Variability (Primary Clinical Parameters)	o Comparison of user variability for primary clinical parameters (measured as the coefficient variation for binary assessment of whether the study is of diagnostic quality to make a particular clinical assessment)	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Secondary	Inter-User Variability (Acquisition Time)	o View level acquisition time (minutes and seconds)	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Secondary	Patient-Level Acquisition time	o Patient level acquisition time (minutes and seconds)	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Secondary	View-Level Acquisition time	o View-level acquisition time (minutes and seconds)	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Secondary	Comparison of study exam and control exam (View-Level Results)	o Comparison of View level results measured as percent agreement of images with diagnostic quality	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Secondary	Comparison of study exam and control exam (Patient-Level Results)	o Comparison of patient level results measured as percent agreement of patient exams of sufficient quality to make a particular clinical assessment	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Secondary	Comparison of study exam and control exam (Task-Based Assessment)	o Comparison of qualitative assessments from study and control exam to assess whether cardiologists reach a similar decision with study exam images and control exam images	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments