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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01574690
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : February 8, 2013
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
Mespere Lifesciences Inc.

Study Description
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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).

Condition or disease Intervention/treatment
Central Venous Pressure Device: Mespere Venus System Procedure: Right heart catheterization (RHC) Procedure: Physical examination of jugular vein

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.

Study Design
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Study Type : Observational
Actual Enrollment : 50 participants
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
Study Start Date : April 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

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MedlinePlus related topics: Health Checkup

Groups and Cohorts
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Group/Cohort Intervention/treatment
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 system

Procedure: 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)


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with heart failure (HF)
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574690


Locations
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United States, Michigan
University of Michigan Cardiovascular Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Mespere Lifesciences Inc.
University of Michigan
Investigators
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Principal Investigator: Todd M Koelling, MD University of Michigan
More Information
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Responsible Party: Mespere Lifesciences Inc.
ClinicalTrials.gov Identifier: NCT01574690    
Other Study ID Numbers: MLS STP-9000008
HUM00054670 ( Other Identifier: University of Michigan )
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: February 8, 2013
Last Verified: February 2013
Keywords provided by Mespere Lifesciences Inc.:
central venous pressure
right heart catheter (RHC)
non-invasive monitor
physical exam of jugular venous pressure
heart failure (HF)