Correlation of Physical Exam Versus Non-invasive Assessment Versus Invasive Assessment of Central Venous Pressure
2 other identifiers
observational
50
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2012
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 5, 2012
CompletedFirst Posted
Study publicly available on registry
April 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFebruary 8, 2013
February 1, 2013
9 months
April 5, 2012
February 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Heart failure patients
50 subjects (both male and female) Heart failure patients already receiving RHC as part of their usual care
Interventions
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
Invasive procedure to assess CVP. Standard of care.
Physicians assess CVP using the subject's jugular vein.
Eligibility Criteria
Adult patients with heart failure (HF)
You may qualify if:
- Age 18 and older
- Heart failure patients already receiving RHC as part of their usual care
- Signed written and informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mespere Lifesciences Inc.lead
- University of Michigancollaborator
Study Sites (1)
University of Michigan Cardiovascular Center
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Todd M Koelling, MD
University of Michigan
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2012
First Posted
April 10, 2012
Study Start
April 1, 2012
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
February 8, 2013
Record last verified: 2013-02