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Clinical Trials/NCT01574690
NCT01574690
Completed
Not Applicable

Correlation of Physical Exam Versus Non-invasive Near-infrared Spectroscopy Versus Invasive Hemodynamic Assessment of Central Venous Pressure

Mespere Lifesciences Inc.1 site in 1 country50 target enrollmentApril 2012

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.

Registry
clinicaltrials.gov
Start Date
April 2012
End Date
January 2013
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Study Sites (1)

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