Correlation of Physical Exam Versus Non-invasive Near-infrared Spectroscopy Versus Invasive Hemodynamic Assessment of Central Venous Pressure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Central Venous Pressure
- Sponsor
- Mespere Lifesciences Inc.
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Central Venous Pressure (CVP)
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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