Point-of-Care Echocardiography With Assistance Technology

Not Applicable

Completed

• Conditions: Cardiac Disease

• Registration Number: NCT03897140
• Lead Sponsor: Sara Guttas

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).

Study Timeline

• Study First Submitted: 2019-03-23
• Study Start: 2019-03-25
• Study First Submitted QC: 2019-03-28
• Study First Posted: 2019-04-01
• Primary Completion: 2019-05-23
• Study Completion: 2019-05-23
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-13
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Study-level Assessment	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments	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.

Secondary Outcome Measures

Name	Time	Method
View-level Assessment	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments	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.
Inter-User Variability (Primary Clinical Parameters)	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments	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)
Inter-User Variability (Acquisition Time)	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments	o View level acquisition time (minutes and seconds)
Patient-Level Acquisition time	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments	o Patient level acquisition time (minutes and seconds)
View-Level Acquisition time	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments	o View-level acquisition time (minutes and seconds)
Comparison of study exam and control exam (View-Level Results)	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments	o Comparison of View level results measured as percent agreement of images with diagnostic quality
Comparison of study exam and control exam (Patient-Level Results)	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments	o Comparison of patient level results measured as percent agreement of patient exams of sufficient quality to make a particular clinical assessment
Comparison of study exam and control exam (Task-Based Assessment)	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments	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

Trial Locations

Locations (2)

Minneapolis Heart Institute; 🇺🇸 Minneapolis, Minnesota, United States

Northwestern Medicine, Bluhm Cardiovascular Institute; 🇺🇸 Chicago, Illinois, United States