Clinical trial NCT01574690: Correlation of Physical Exam Versus Non-invasive Assessment Versus Invasive Assessment of Central Venous Pressure
Official title: Correlation of Physical Exam Versus Non-invasive Near-infrared Spectroscopy Versus Invasive Hemodynamic Assessment of Central Venous Pressure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Venous Pressure
Keywords: central venous pressure
right heart catheter (RHC)
non-invasive monitor
physical exam of jugular venous pressure
heart failure (HF)
Lead sponsor: Mespere Lifesciences Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Michigan
First posted: 2012-04-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with heart failure (HF)

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.

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

Primary outcomes:
measure: Central Venous Pressure (CVP)
timeFrame: 0-3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Cardiovascular Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Todd M Koelling, MD
role: PRINCIPAL_INVESTIGATOR
References: