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

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

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).

Study Overview

• Status: Completed
• Conditions: Central Venous Pressure
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Cardiovascular Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with heart failure (HF)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: 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 Names: Jugular venous pressure (JVP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Mespere Lifesciences Inc.
• Collaborators: University of Michigan

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: April 5, 2012
• First Submitted That Met QC Criteria: April 9, 2012
• First Posted (Estimate): April 10, 2012

Study Record Updates

• Last Update Posted (Estimate): February 8, 2013
• Last Update Submitted That Met QC Criteria: February 7, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: central venous pressure; heart failure (HF); right heart catheter (RHC); non-invasive monitor; physical exam of jugular venous pressure
• Other Study ID Numbers: MLS STP-9000008; HUM00054670 (Other Identifier: University of Michigan)