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

Central Venous Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01574690
• Other study ID #: MLS STP-9000008
• Secondary ID: HUM00054670
• Status: Completed
• Phase: N/A
• First received: April 5, 2012
• Last updated: February 7, 2013
• Start date: April 2012
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: Mespere Lifesciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Central Venous Pressure

Intervention

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

Procedure:
• Right heart catheterization (RHC)
Invasive procedure to assess CVP. Standard of care.
• Physical examination of jugular vein
Physicians assess CVP using the subject's jugular vein.

Locations

Country	Name	City	State
United States	University of Michigan Cardiovascular Center	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Mespere Lifesciences Inc.	University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No