Heart FailureNCT04179851
Comparison of Non-invasive to Invasive Assessment of Jugular Venous Pressure
An observational study of Heart Failure and Congestion, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
Assessment of the jugular venous pressure (JVP) is an important clinical sign and correlates with right atrial (RA) pressure. A patient with heart failure (HF) typically has an elevated JVP, but in cases of dehydration JVP may be low. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure, Congestion
- What is being tested?
- Thermal imaging of neck veins
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 5 Feb 2017to 31 Dec 2019
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients scheduled for right heart catheterization at the Shaare Zedek Medical Center for non-study related medical indications will be approached
Who may be able to join
- Patients already scheduled for right heart catheterization for clinical indication
- Age 18-90
Who cannot join
- Local scar wound or bruise in the right side of the neck.
- Current upper torso central venous catheterization such as a PICC line or dialysis catheter.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Shaare zedek MC
Jerusalem
Tal Hasin, MD, 972-2-6555872, hasint@szmc.org.il
Astrid Rozanski, 972-2-6555956, astrid@szma.org.il
About this study
Assessment of the jugular venous pressure (JVP) is an important clinical sign and correlates with right atrial (RA) pressure. A patient with heart failure (HF) typically has an elevated JVP, but in cases of dehydration JVP may be low. Assessment of the JVP is key to the management of patients with fluid overload or needing diuretics. Currently the assessment of JVP is made by the physician by direct visualization of the neck veins. However this is inaccurate, may vary between investigators and depends largely on the patient's habitus. The JVP and RA pressures may also be directly measured by catheterization (a routine during right heart catheterization), but this is an invasive procedure that is seldom performed.
A thermal movie of the external jugular vein at a specific neck position may help to measure the JVP. In this study different modalities of JVP assessment (clinical assessment, thermal image and invasive measurement) are to be compared
Read more
Patients scheduled for right heart catheterization at the Shaare Zedek Medical Center for non-study related medical indications will be approached.
Non-invasive estimates of JVP will be performed independently prior to the right heart catheterization, during the waiting period (within 2 hours) prior to catheterization. These will include up to 2min of thermal camera recording (to be analysed offline) and a physician's JVP evaluation. The angle of the patient's upper body will be 30-60°, the rotation of the neck will be optimal for filming, and the neck area may be cooled to enhance the images. Blinding to the results will be confirmed by performance with separate investigators and separate data registration. Right heart catheterization will then be performed and RA pressure will be recorded, as well as pulmonary and wedge pressures. JVP measured by physician and thermal image will be matched with invasive catheterization (the gold standard) using Bland Altman plots and Spearmann correlation and comparison between methods will be performed.
- Conditions
- Heart Failure, Congestion
- Being tested
- Thermal imaging of neck veins
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal imaging of neck veinsDiagnostic test
Thermal imaging of neck veins
What is being measured
The primary outcome is the main question the study is designed to answer.
central venous pressure (direct and indirect evaluation)
comparison of estimated venous pressure (in mmHg) to the direct measurement during right heart catheterization
Measured: up to 30 days for analysis of the thermal images, up to 24hours for the direct measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start5 Feb 2017
- Primary completion30 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tal Hasin, MD, Principal investigator, SaareZMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179851
- Sponsor's protocol ID
- Venovision1
- Status last verified
- Nov 2019
- First submitted
- 21 Nov 2019
- Last updated
- 27 Nov 2019
- 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 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Non-invasive to Invasive Assessment of Jugular Venous Pressure
- ClinicalTrials.gov ID
- NCT04179851
- Acronym / sponsor ID
- Venovision1
- Conditions
- Heart Failure, Congestion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- 5 Feb 2017 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 27 Nov 2019 (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.
Assessment of the jugular venous pressure (JVP) is an important clinical sign and correlates with right atrial (RA) pressure. A patient with heart failure (HF) typically has an elevated JVP, but in cases of dehydration JVP may be low. Assessment of the JVP is key to the management of patients with fluid overload or needing diuretics. Currently the assessment of JVP is made by the physician by direct visualization of the neck veins. However this is inaccurate, may vary between investigators and depends largely on the patient's habitus. The JVP and RA pressures may also be directly measured by catheterization (a routine during right heart catheterization), but this is an invasive procedure that is seldom performed.
A thermal movie of the external jugular vein at a specific neck position may help to measure the JVP. In this study different modalities of JVP assessment (clinical assessment, thermal image and invasive measurement) are to be compared
Patients scheduled for right heart catheterization at the Shaare Zedek Medical Center for non-study related medical indications will be approached.
Non-invasive estimates of JVP will be performed independently prior to the right heart catheterization, during the waiting period (within 2 hours) prior to catheterization. These will include up to 2min of thermal camera recording (to be analysed offline) and a physician's JVP evaluation. The angle of the patient's upper body will be 30-60°, the rotation of the neck will be optimal for filming, and the neck area may be cooled to enhance the images. Blinding to the results will be confirmed by performance with separate investigators and separate data registration. Right heart catheterization will then be performed and RA pressure will be recorded, as well as pulmonary and wedge pressures. JVP measured by physician and thermal image will be matched with invasive catheterization (the gold standard) using Bland Altman plots and Spearmann correlation and comparison between methods will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for right heart catheterization at the Shaare Zedek Medical Center for non-study related medical indications will be approached
Key inclusion criteria (2 listed)
- Patients already scheduled for right heart catheterization for clinical indication
- Age 18-90
Key exclusion criteria (2 listed)
- Local scar wound or bruise in the right side of the neck.
- Current upper torso central venous catheterization such as a PICC line or dialysis catheter.
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 |
|---|---|---|
| Thermal imaging of neck veinsThermal imaging of neck veins | Diagnostic test | – |
Primary outcome
central venous pressure (direct and indirect evaluation)
Time frame: up to 30 days for analysis of the thermal images, up to 24hours for the direct measurement
comparison of estimated venous pressure (in mmHg) to the direct measurement during right heart catheterization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- 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.
Tal Hasin, MD principal investigator
SaareZMC
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 Heart Failure and Congestion, run by Shaare Zedek Medical Center at 1 site in Israel.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Nov 2019. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tal Hasin, MD (972-2-6555872, hasint@szmc.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
central venous pressure (direct and indirect evaluation) (time frame: up to 30 days for analysis of the thermal images, up to 24hours for the direct measurement). 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 27 Nov 2019; AzTrials last refreshed its copy on 8 Nov 2026.