Office-based Validation of the JVPHome

NCT05193864 | Unknown

• 1 other identifier: 335576
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congestive Heart Failure

Keywords

Remote Monitoring, Machine Vision

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Electrocardiographic Assessment

  Day 1

• Pulse Oximetry Assessment

  Day 1

• Respiratory Rate

  Day 1

Study Arms (1)

Ambulatory CHF patients

Patients visiting an outpatient CHF clinic

Device: Device: JVPHome and ultrasound

Interventions

Device: JVPHome and ultrasound DEVICE

Remote clinician assessment of JVP height using the JVPHome, and ultrasound based assessment of JVP height in the same patients.

Ambulatory CHF patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Eastern Regional Health Authority: lead
• JVPLabs: collaborator

Study Sites (1)

Eastern Health

St. John's, Newfoundland and Labrador, A1B 2X5, Canada

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Kris Aubrey-Bassler, MD

  Eastern Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krista Rideout, MN

CONTACT

(709) 777 2638; krista.rideout@easternhealth.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: January 18, 2022
• Study Start: November 29, 2021
• Primary Completion: November 3, 2022
• Study Completion: January 3, 2023
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)