Congestive Heart FailureNCT04807985
Feasibility of Remote JVP Assessment
An observational study of Congestive Heart Failure, run by Eastern Regional Health Authority at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- JVPHome and ultrasound
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2021to 1 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ambulatory CHF outpatients followed at the specialty heart failure clinic at Eastern Health in St. John's, Newfoundland and Labrador, Canada
Who may be able to join
- Age >/= 18 years
- Congestive heart failure diagnosis receiving ongoing treatment
- Able to provide informed consent
Who cannot join
- 1. Conditions which preclude visualization of the JVP, including neck deformity, scarring, and facial hair
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Remote Assessment of the Jugular Venous Pressure
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 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.
Read the 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 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. 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 values remotely based on the machine enhanced images generated by the JVPHome. Analyses will then assess the accuracy of the JVPHome relative to ultrasound and expert clinical assessment.
- Conditions
- Congestive Heart Failure
- Being tested
- JVPHome and ultrasound
- Keywords
- Jugular Venous Pressure, Remote Monitoring, Machine Vision, Telemedicine
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JVPHome and ultrasoundDevice
Remote clinician assessment of JVP height using the JVPHome, and ultrasound based assessment of JVP height in the same patients.
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory CHF patients | Patients visiting an outpatient CHF clinic Receives: Device: JVPHome and ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of JVP assessment using the JVPHome
Correlation between JVP height assessed by JVPHome and ultrasound
Measured: Baseline
Secondary outcomes (2)
Agreement between JVPHome and ultrasound
Proportion of JVP measurements by JVPHome and ultrasound that are within 1 cm of each
Measured: Baseline
JVP Visualization
Proportion of study participants for whom the JVP was visible using the JVPHome
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start1 Jan 2021
- Primary completion30 Aug 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Regional Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- JVPLabs
- Responsible party
- Sponsor
- Investigators
- Kris Aubrey-Bassler, MD, Principal investigator, Eastern Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807985
- Sponsor's protocol ID
- 2019.128
- Status last verified
- Mar 2021
- First submitted
- 16 Mar 2021
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Remote Assessment of the Jugular Venous Pressure
- ClinicalTrials.gov ID
- NCT04807985
- Acronym / sponsor ID
- 2019.128
- Conditions
- Congestive Heart Failure
- Keywords
- Jugular Venous Pressure, Remote Monitoring, Machine Vision, Telemedicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Eastern Regional Health AuthorityUniversity, hospital or other
- Collaborators
- JVPLabs
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
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 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. 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 values remotely based on the machine enhanced images generated by the JVPHome. Analyses will then assess the accuracy of the JVPHome relative to ultrasound and expert clinical assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ambulatory CHF patients | – | Device: JVPHome and ultrasoundPatients visiting an outpatient CHF clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ambulatory CHF outpatients followed at the specialty heart failure clinic at Eastern Health in St. John's, Newfoundland and Labrador, Canada
Key inclusion criteria (3 listed)
- Age >/= 18 years
- Congestive heart failure diagnosis receiving ongoing treatment
- Able to provide informed consent
Key exclusion criteria (1 listed)
- 1. Conditions which preclude visualization of the JVP, including neck deformity, scarring, and facial hair
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JVPHome and ultrasoundRemote clinician assessment of JVP height using the JVPHome, and ultrasound based assessment of JVP height in the same patients. | Device | Ambulatory CHF patients |
Primary outcome
Accuracy of JVP assessment using the JVPHome
Time frame: Baseline
Correlation between JVP height assessed by JVPHome and ultrasound
2 secondary outcomes
Agreement between JVPHome and ultrasound
Time frame: Baseline
JVP Visualization
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kris Aubrey-Bassler, MD principal investigator
Eastern Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, run by Eastern Regional Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of JVP assessment using the JVPHome (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.