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

This study has been completed.
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
Mespere Lifesciences Inc.
ClinicalTrials.gov Identifier:
NCT01574690
First received: April 5, 2012
Last updated: February 7, 2013
Last verified: February 2013
  Purpose

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).


Condition Intervention
Central Venous Pressure
Device: Mespere Venus System
Procedure: Right heart catheterization (RHC)
Procedure: Physical examination of jugular vein

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation of Physical Exam Versus Non-invasive Near-infrared Spectroscopy Versus Invasive Hemodynamic Assessment of Central Venous Pressure

Resource links provided by NLM:


Further study details as provided by Mespere Lifesciences Inc.:

Primary Outcome Measures:
  • Central Venous Pressure (CVP) [ Time Frame: 0-3 hours ] [ Designated as safety issue: No ]
    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


Enrollment: 50
Study Start Date: April 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: Jugular venous pressure (JVP)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients with heart failure (HF)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574690

Locations
United States, Michigan
University of Michigan Cardiovascular Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Mespere Lifesciences Inc.
University of Michigan
Investigators
Principal Investigator: Todd M Koelling, MD University of Michigan
  More Information

No publications provided

Responsible Party: Mespere Lifesciences Inc.
ClinicalTrials.gov Identifier: NCT01574690     History of Changes
Other Study ID Numbers: MLS STP-9000008, HUM00054670
Study First Received: April 5, 2012
Last Updated: February 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mespere Lifesciences Inc.:
central venous pressure
right heart catheter (RHC)
non-invasive monitor
physical exam of jugular venous pressure
heart failure (HF)

ClinicalTrials.gov processed this record on September 16, 2014