Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2021-11-29
2023-01-03
Brief Summary
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Detailed Description
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The key feature of the physical examination for assessing the volume status of CHF patients is the JVP, which manifests as a biphasic pulsation along the neck. The height of the JVP relative to the sternal angle is a reflection of right atrial pressure, which increases in response to higher pressures transmitted from the left side of the heart. Pathologic elevation of left sided heart pressures can result in fluid congestion in the lungs, which can cause patients to develop shortness of breath and reduced blood oxygen levels. Although a crucial marker of volume status, accurate identification of the JVP can be challenging for physicians due to its pulsations often being subtle.
The JVPHome is a novel medical device designed to facilitate visualization of JVP height relative to the sternal angle through the use of machine vision. The current study aims to evaluate an enhanced version of the JVPHome in a clinic setting when the device is applied to CHF patients by clinicians. Following its application, the JVPHome will be allowed to record a video of the JVP and images will subsequently be transmitted to a secure cloud and undergo analysis with machine vision software. Visualization of the JVP will be facilitated through simultaneous electrocardiographic and pulse oximetry recordings by the JVPHome. Following its application, data is transferred to a secure cloud server for subsequent processing and clinical review.
JVP height of study participants will be concurrently assessed through the use of ultrasound (gold standard). Clinicians that are blinded to ultrasound determined JVP height values will assess JVP height generated by the JVPHome. Analyses will then assess the accuracy of the JVPHome relative to ultrasound and expert clinical assessment.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ambulatory CHF patients
Patients visiting an outpatient CHF clinic
Device: JVPHome and ultrasound
Remote clinician assessment of JVP height using the JVPHome, and ultrasound based assessment of JVP height in the same patients.
Interventions
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Device: JVPHome and ultrasound
Remote clinician assessment of JVP height using the JVPHome, and ultrasound based assessment of JVP height in the same patients.
Eligibility Criteria
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Inclusion Criteria
* Congestive heart failure diagnosis receiving ongoing treatment
* Able to provide informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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JVPLabs
UNKNOWN
Eastern Regional Health Authority
OTHER
Responsible Party
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Principal Investigators
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Kris Aubrey-Bassler, MD
Role: PRINCIPAL_INVESTIGATOR
Eastern Health
Locations
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Eastern Health
St. John's, Newfoundland and Labrador, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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335576
Identifier Type: -
Identifier Source: org_study_id
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