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Completed

NCT Number: NCT03897140

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).

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Key information

Conditions

Cardiac Disease Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Medicine, Bluhm Cardiovascular Institute, Chicago, Illinois, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic Test: Limited Echocardiogram

Diagnostic Test

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.

Primary outcomes

  1. Study-level Assessment

    Time frame: 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 outcomes

  1. View-level Assessment

    Time frame: 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.

  2. Inter-User Variability (Primary Clinical Parameters)

    Time frame: 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)

  3. Inter-User Variability (Acquisition Time)

    Time frame: 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)

  4. Patient-Level Acquisition time

    Time frame: 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)

  5. View-Level Acquisition time

    Time frame: 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)

  6. Comparison of study exam and control exam (View-Level Results)

    Time frame: 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

  7. Comparison of study exam and control exam (Patient-Level Results)

    Time frame: 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

  8. Comparison of study exam and control exam (Task-Based Assessment)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Sara Guttas

Industry

Registry information

Official study title

Study for Point-of-Care Echocardiography With Assistance Technology

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 1, 2019
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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