Central Venous PressureNCT01574690
Correlation of Physical Exam Versus Non-invasive Assessment Versus Invasive Assessment of Central Venous Pressure
An observational study of Central Venous Pressure, run by Mespere Lifesciences Inc. at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Venous Pressure
- What is being tested?
- Mespere Venus System, Right heart catheterization (RHC) and Physical examination of jugular vein
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with heart failure (HF)
Who may be able to join
- Age 18 and older
- Heart failure patients already receiving RHC as part of their usual care
- Signed written and informed consent
Who cannot join
- 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
Show all 10Show fewer
- Previous cardiac transplant
- Unable to identify external jugular vein
- Ongoing photodynamic therapy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Cardiovascular Center
Ann Arbor, Michigan, 48109
About this study
Official title: Correlation of Physical Exam Versus Non-invasive Near-infrared Spectroscopy Versus Invasive Hemodynamic Assessment of Central Venous Pressure
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).
Read the 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.
- Conditions
- Central Venous Pressure
- Being tested
- Mespere Venus System, Right heart catheterization (RHC), Physical examination of jugular vein
- Keywords
- central venous pressure, right heart catheter (RHC), non-invasive monitor, physical exam of jugular venous pressure, heart failure (HF)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mespere Venus SystemDevice
Also called Non-invasive central venous pressure 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
Right heart catheterization (RHC)Procedure or surgery
Invasive procedure to assess CVP. Standard of care.
Physical examination of jugular veinProcedure or surgery
Also called Jugular venous pressure (JVP)
Physicians assess CVP using the subject's jugular vein.
| Study group | Role | What they receive |
|---|---|---|
| Heart failure patients | 50 subjects (both male and female) Heart failure patients already receiving RHC as part of their usual care Receives: Device: Mespere Venus System; Procedure: Right heart catheterization (RHC); Procedure: Physical examination of jugular vein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mespere Lifesciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Michigan
- Responsible party
- Sponsor
- Investigators
- Todd M Koelling, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574690
- Sponsor's protocol ID
- MLS STP-9000008
- Other IDs
- HUM00054670
- Status last verified
- Feb 2013
- First submitted
- 5 Apr 2012
- Last updated
- 8 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Physical Exam Versus Non-invasive Near-infrared Spectroscopy Versus Invasive Hemodynamic Assessment of Central Venous Pressure
- ClinicalTrials.gov ID
- NCT01574690
- Acronym / sponsor ID
- MLS STP-9000008
- Conditions
- Central Venous Pressure
- Keywords
- central venous pressure, right heart catheter (RHC), non-invasive monitor, physical exam of jugular venous pressure, heart failure (HF)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mespere Lifesciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Michigan
- Study start
- Apr 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 10 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart failure patients | – | Device: Mespere Venus System, Procedure: Right heart catheterization (RHC), Procedure: Physical examination of jugular vein50 subjects (both male and female) Heart failure patients already receiving RHC as part of their usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with heart failure (HF)
Key inclusion criteria (3 listed)
- Age 18 and older
- Heart failure patients already receiving RHC as part of their usual care
- Signed written and informed consent
Key exclusion criteria (10 listed)
- Lack of patient consent
- Presence of known anatomical shunt or AV dialysis fistula
- Sepsis, fever
- Anemia (Hgb < 10)
- Allergy to adhesive tape
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mespere Venus SystemAlso: Non-invasive central venous pressure systemFor 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 | Device | Heart failure patients |
| Right heart catheterization (RHC)Invasive procedure to assess CVP. Standard of care. | Procedure or surgery | Heart failure patients |
| Physical examination of jugular veinAlso: Jugular venous pressure (JVP)Physicians assess CVP using the subject's jugular vein. | Procedure or surgery | Heart failure patients |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd M Koelling, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Venous Pressure, run by Mespere Lifesciences Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Venous Pressure (CVP) (time frame: 0-3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2013.