Office-based Validation of the JVPHome

Congestive Heart Failure Clinical Trial

Official title:

Office-based Validation of the JVPHome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05193864
• Other study ID #: 335576
• Status: Recruiting
• Start date: November 29, 2021
• Est. completion date: January 3, 2023

Study information

• Verified date: July 2022
• Source: Eastern Regional Health Authority
• Contact: Krista Rideout, MN
• Phone: (709) 777 2638
• Email: krista.rideout[@]easternhealth.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 3, 2023
• Est. primary completion date: November 3, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Canada	Eastern Health	St. John's	Newfoundland and Labrador

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Regional Health Authority	JVPLabs

Country where clinical trial is conducted

Canada, 

Outcome

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