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Completed

NCT Number: NCT01574690

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan Cardiovascular Center

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mespere Venus System

Device

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

Other names: Non-invasive central venous pressure system

Right heart catheterization (RHC)

Procedure

Invasive procedure to assess CVP. Standard of care.

Physical examination of jugular vein

Procedure

Physicians assess CVP using the subject's jugular vein.

Other names: Jugular venous pressure (JVP)

Primary outcomes

  1. Central Venous Pressure (CVP)

    Time frame: 0-3 hours

    To 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

Sponsors and collaborators

Lead sponsor

Mespere Lifesciences Inc.

Industry

Collaborators

  • University of Michigan

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 10, 2012
Registry last updated
Feb 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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