Comparison of Non-invasive to Invasive Assessment of Jugular Venous Pressure

NCT04179851 | Unknown

• 1 other identifier: Venovision1
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Heart Failure; Congestion

Outcome Measures

Primary Outcomes (1)

• central venous pressure (direct and indirect evaluation)

  comparison of estimated venous pressure (in mmHg) to the direct measurement during right heart catheterization

  up to 30 days for analysis of the thermal images, up to 24hours for the direct measurement

Interventions

Thermal imaging of neck veins DIAGNOSTIC_TEST

Thermal imaging of neck veins

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for right heart catheterization at the Shaare Zedek Medical Center for non-study related medical indications will be approached

You may qualify if:

• Patients already scheduled for right heart catheterization for clinical indication
• Age 18-90

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare zedek MC

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Tal Hasin, MD

  SaareZMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tal Hasin, MD

CONTACT

972-2-6555872; hasint@szmc.org.il

Astrid Rojanski

CONTACT

972-2-6555956; astrid@szmc.org.il

Study Design

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

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 27, 2019
• Study Start: February 5, 2017
• Primary Completion: December 30, 2019
• Study Completion: December 31, 2019
• Last Updated: November 27, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)