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

Completed

• Conditions: Central Venous Pressure
• Interventions: Device: Mespere Venus System; Procedure: Right heart catheterization (RHC); Procedure: Physical examination of jugular vein

• Registration Number: NCT01574690
• Lead Sponsor: Mespere Lifesciences Inc.

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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-05
• Study First Submitted QC: 2012-04-09
• Study First Posted: 2012-04-10
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-07
• Last Update Posted: 2013-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heart failure patients	Mespere Venus System	50 subjects (both male and female) Heart failure patients already receiving RHC as part of their usual care
Heart failure patients	Right heart catheterization (RHC)	50 subjects (both male and female) Heart failure patients already receiving RHC as part of their usual care
Heart failure patients	Physical examination of jugular vein	50 subjects (both male and female) Heart failure patients already receiving RHC as part of their usual care

Primary Outcome Measures

Name	Time	Method
Central Venous Pressure (CVP)	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

Trial Locations

Locations (1)

University of Michigan Cardiovascular Center; 🇺🇸 Ann Arbor, Michigan, United States