Skip to content

Correlation of Physical Exam Versus Non-invasive Assessment Versus Invasive Assessment of Central Venous Pressure

Correlation of Physical Exam Versus Non-invasive Near-infrared Spectroscopy Versus Invasive Hemodynamic Assessment of Central Venous Pressure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01574690
Enrollment
50
Registered
2012-04-10
Start date
2012-04-30
Completion date
2013-01-31
Last updated
2013-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Venous Pressure

Keywords

central venous pressure, right heart catheter (RHC), non-invasive monitor, physical exam of jugular venous pressure, heart failure (HF)

Brief summary

The purpose of this study is to establish the accuracy of a non-invasive device that uses near infrared spectroscopy (NIRS) to estimate central venous pressure (CVP) comparing it to physical exam and invasive hemodynamic measurement via right heart catheterization (RHC).

Detailed description

Estimation of volume status is crucial when making treatment decisions for heart failure patients. Volume status is often assessed clinically by estimating the CVP, which is an estimate of right atrial filling pressure, by assessing the level of jugular venous distention. This method is quick and non-invasive but can be prone erroneous measurement due to human error and limitations secondary to body habitus and anatomical variation. RHC is a procedure used for invasive hemodynamic measurement commonly used in heart failure patients. CVP can be measured directly via RHC using a pulmonary artery catheter. It is considered the gold standard for measuring intra-cardiac filling pressures and calculation of cardiac output and pulmonary and systemic vascular resistance. The obvious downside of RHC is that is invasive, time consuming, and has many potential serious risks including vascular complication, pneumothorax, infection, arrhythmia, valvular damage, etc. A non-invasive, quick, and accurate way to estimate central venous pressure and oximetry could benefit patient care. NIRS is an optical imaging technology that has been proposed to estimate central venous pressure non-invasively. Our intent is to determine the accuracy of NIRS in assessment of CVP using the Mespere Venus device.

Interventions

DEVICEMespere Venus System

For this non-invasive system, an adhesive patch (connected to the Mespere Venus system) is placed on the neck of the subject, to determine if the CVP values displayed by the device correlates with the CVP values obtained by RHC and physical exam

Invasive procedure to assess CVP. Standard of care.

Physicians assess CVP using the subject's jugular vein.

Sponsors

University of Michigan
CollaboratorOTHER
Mespere Lifesciences Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 18 and older * Heart failure patients already receiving RHC as part of their usual care * Signed written and informed consent

Exclusion criteria

* Lack of patient consent * Presence of known anatomical shunt or AV dialysis fistula * Sepsis, fever * Anemia (Hgb \< 10) * Allergy to adhesive tape * Known central vein stenosis * Previous cardiac transplant * Unable to identify external jugular vein * Ongoing photodynamic therapy * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Central Venous Pressure (CVP)0-3 hoursTo determine if the CVP from the non-invasive monitor correlates with the CVP from the invasive method (via RHC) and/or the CVP from the physical exam

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026