Office-based Validation of the JVPHome

The JVPHome is a novel medical device that utilizes machine vision in order to facilitate assessment of jugular venous pressure (JVP) height relative to the sternal angle with the ultimate goal of enabling remote JVP monitoring. The current study aims to evaluate the ability of an enhanced version of the JVPHome to enable remote identification of JVP height relative to ultrasound among congestive heart failure (CHF) patients when the device is applied by the study team in the clinic.

Study Overview

• Status: Recruiting
• Conditions: Congestive Heart Failure
• Intervention / Treatment: Device: Device: JVPHome and ultrasound

Detailed Description

CHF is a common and devastating health problem estimated to affect upwards of 26 million individuals worldwide. Following an initial hospitalization for heart failure, approximately 25% of patients are readmitted within the first 30 days of discharge. Repeat heart failure hospitalizations are a major burden on both patients and healthcare systems. To date, there is an absence of non-invasive solutions proven to reduce the risk of re-hospitalization for CHF.

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Krista Rideout, MN; Phone Number: (709) 777 2638; Email: krista.rideout@easternhealth.ca

Study Locations

• Canada
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 2X5
      • Recruiting
      • Eastern Health
      • Contact: Kevin Oram, BSc; Email: kevin.oram@easternhealth.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Ambulatory CHF outpatients followed at the specialty heart failure clinic at Eastern Health in St. John's, Newfoundland and Labrador, Canada

Description

Inclusion Criteria:

• Age >/= 18 years
• Congestive heart failure diagnosis receiving ongoing treatment
• Able to provide informed consent

Exclusion Criteria:

• Conditions which preclude visualization of the JVP, including neck deformity, scarring, and facial hair

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ambulatory CHF patients; Patients visiting an outpatient CHF clinic	Device: Device: JVPHome and ultrasound; Remote clinician assessment of JVP height using the JVPHome, and ultrasound based assessment of JVP height in the same patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of JVP assessment using the JVPHome	Correlation between JVP height assessed by JVPHome and ultrasound Correlation between JVP height assessed by JVPHome and ultrasound Correlation between JVP height assessed by JVPHome and ultrasound	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrocardiographic Assessment	Evaluate the ability of an embedded ECG sensor to generate a quality single-lead ECG sufficient to identify heart rhythm.	Day 1
Pulse Oximetry Assessment	Evaluate the ability of an embedded PPG sensor to generate a quality PPG signal in-clinic.	Day 1
Respiratory Rate	Validate the ability of the JVPHome to measure respiratory rate and compare to expert clinical assessment.	Day 1

Collaborators and Investigators

• Sponsor: Eastern Regional Health Authority
• Collaborators: JVPLabs
• Investigators: Principal Investigator: Kris Aubrey-Bassler, MD, Eastern Health

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2021
• Primary Completion (Anticipated): November 3, 2022
• Study Completion (Anticipated): January 3, 2023

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Remote Monitoring, Machine Vision
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 335576

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No