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

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 Overview

• Status: Unknown
• Conditions: Heart Failure; Congestion
• Intervention / Treatment: Diagnostic test: Thermal imaging of neck veins

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Tal Hasin, MD; Phone Number: 972-2-6555872; Email: hasint@szmc.org.il
• Study Contact Backup: Name: Astrid Rojanski; Phone Number: 972-2-6555956; Email: astrid@szmc.org.il

Study Locations

• Israel
  • Jerusalem, Israel
    • Recruiting
    • Shaare Zedek Mc
    • Contact: Tal Hasin, MD; Phone Number: 972-2-6555872; Email: hasint@szmc.org.il
    • Contact: Astrid Rozanski; Phone Number: 972-2-6555956; Email: astrid@szma.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

1. Patients already scheduled for right heart catheterization for clinical indication
2. Age 18-90

Exclusion Criteria:

1. Local scar wound or bruise in the right side of the neck.
2. Current upper torso central venous catheterization such as a PICC line or dialysis catheter.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shaare Zedek Medical Center
• Investigators: Principal Investigator: Tal Hasin, MD, SaareZMC

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2017
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 27, 2019

Study Record Updates

• Last Update Posted (Actual): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 25, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Venovision1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No