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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
240
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.
Northwestern Medicine, Bluhm Cardiovascular Institute
Chicago, Illinois, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
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.
Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
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.
Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
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)
Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Inter-User Variability (Acquisition Time)
o View level acquisition time (minutes and seconds)
Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
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Patient-Level Acquisition time
o Patient level acquisition time (minutes and seconds)
Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
View-Level Acquisition time
o View-level acquisition time (minutes and seconds)
Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
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
Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
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
Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
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
Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments