Correlation of Physical Exam Versus Non-invasive Assessment Versus Invasive Assessment of Central Venous Pressure
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01574690 |
Recruitment Status :
Completed
First Posted : April 10, 2012
Last Update Posted : February 8, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Central Venous Pressure | Device: Mespere Venus System Procedure: Right heart catheterization (RHC) Procedure: Physical examination of jugular vein |
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 |
Actual Enrollment : | 50 participants |
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 |
Study Start Date : | April 2012 |
Actual Primary Completion Date : | January 2013 |
Actual Study Completion Date : | January 2013 |

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 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) |
- Central Venous Pressure (CVP) [ Time Frame: 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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574690
United States, Michigan | |
University of Michigan Cardiovascular Center | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Todd M Koelling, MD | University of Michigan |
Responsible Party: | Mespere Lifesciences Inc. |
ClinicalTrials.gov Identifier: | NCT01574690 |
Other Study ID Numbers: |
MLS STP-9000008 HUM00054670 ( Other Identifier: University of Michigan ) |
First Posted: | April 10, 2012 Key Record Dates |
Last Update Posted: | February 8, 2013 |
Last Verified: | February 2013 |
central venous pressure right heart catheter (RHC) non-invasive monitor physical exam of jugular venous pressure heart failure (HF) |