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).
Central Venous Pressure
Device: Mespere Venus System
Procedure: Right heart catheterization (RHC)
Procedure: Physical examination of jugular vein
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Correlation of Physical Exam Versus Non-invasive Near-infrared Spectroscopy Versus Invasive Hemodynamic Assessment of Central Venous Pressure|
- Central Venous Pressure (CVP) [ Time Frame: 0-3 hours ] [ Designated as safety issue: No ]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
|Study Start Date:||April 2012|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Heart failure patients
50 subjects (both male and female) Heart failure patients already receiving RHC as part of their usual care
Device: Mespere 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
Other Name: Non-invasive central venous pressure systemProcedure: Right heart catheterization (RHC)
Invasive procedure to assess CVP. Standard of care.Procedure: Physical examination of jugular vein
Physicians assess CVP using the subject's jugular vein.
Other Name: Jugular venous pressure (JVP)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01574690
|United States, Michigan|
|University of Michigan Cardiovascular Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Todd M Koelling, MD||University of Michigan|