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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00054670 | Other Identifier | University of Michigan |
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| Name | Class |
|---|---|
| University of Michigan | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart failure patients | 50 subjects (both male and female) Heart failure patients already receiving RHC as part of their usual care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Central Venous Pressure (CVP) | 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 | 0-3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with heart failure (HF)
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| Name | Affiliation | Role |
|---|---|---|
| Todd M Koelling, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Cardiovascular Center | Ann Arbor | Michigan | 48109 | United States |
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| Right heart catheterization (RHC) | Procedure | Invasive procedure to assess CVP. Standard of care. |
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| Physical examination of jugular vein | Procedure | Physicians assess CVP using the subject's jugular vein. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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