Correlation of Physical Exam Versus Non-invasive Assessment Versus Invasive Assessment of Central Venous Pressure
NCT ID: NCT01574690
Last Updated: 2013-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2012-04-30
2013-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Heart failure patients
50 subjects (both male and female) Heart failure patients already receiving RHC as part of their usual care
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
Right heart catheterization (RHC)
Invasive procedure to assess CVP. Standard of care.
Physical examination of jugular vein
Physicians assess CVP using the subject's jugular vein.
Interventions
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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
Right heart catheterization (RHC)
Invasive procedure to assess CVP. Standard of care.
Physical examination of jugular vein
Physicians assess CVP using the subject's jugular vein.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Heart failure patients already receiving RHC as part of their usual care
* Signed written and informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Mespere Lifesciences Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Todd M Koelling, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan Cardiovascular Center
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00054670
Identifier Type: OTHER
Identifier Source: secondary_id
MLS STP-9000008
Identifier Type: -
Identifier Source: org_study_id
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