Central Venous PressureNCT01243515
Comparison of a Non-Invasive Central Venous Pressure Device and Physical Examination in Patients With Chronic Kidney Disease
An observational study of Central Venous Pressure, run by Mespere Lifesciences Inc. at 1 site in Canada.
Trial summary
The primary objective of this study is to determine whether a correlation exists between the Mespere Non-Invasive Central Venous Pressure (NICVP) device for measuring central venous pressure (CVP), and assessment of CVP via physical examination. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Central Venous Pressure
- What is being tested?
- Non-Invasive Central Venous Pressure monitor and Physical examination of jugular vein
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with Chronic Kidney Disease (CKD)
Who may be able to join
- Age 18 years or older at the time of enrolment
- Chronic Kidney Disease patients and healthy volunteers
- Participants should be able to provide written informed consent
- Subject is termed eligible as determined by Pre-Screening Phase (as defined in protocol)
Who cannot join
- Unable to identify external jugular vein (EJV)
- Unable to identify internal jugular vein (IJV)
- Unable to access right side of subject's neck
- Allergic to adhesive tape
- History of central vein stenosis
- Undergoing photodynamic therapy (PDT)
- Presence of an arteriovenous fistula
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Validation of a Non-Invasive Central Venous Pressure Device in Comparison With Physical Examination in Patients With Chronic Kidney Disease and Healthy Volunteers
The primary objective of this study is to determine whether a correlation exists between the Mespere Non-Invasive Central Venous Pressure (NICVP) device for measuring central venous pressure (CVP), and assessment of CVP via physical examination.
Read the detailed description
The estimation of central venous pressure (CVP) is part of routine clinical examination. Central venous pressure is the indication of the pressure in the right atrium of the heart and it can be measured by determining the height of the blood column in the internal or external jugular vein. Clinical use of CVP has a wide range of applications including diagnosis of heart failure, pleural effusion, hypervolemia, hypovolemia, and sepsis. The standard clinical method for attaining CVP non-invasively is the physical examination of jugular venous pulse (JVP). The JVP provides a useful estimate of the CVP.
It is often difficult to identify the internal jugular vein to determine the JVP. The internal jugular vein is deep and adjacent to the carotid artery and pulsations derived from the artery may obscure the subtle venous pulsations. Manoeuvres to differentiate carotid pulsation and jugular pulsation are helpful in identifying the internal jugular vein, however determining the JVP based on the internal jugular vein examination is difficult.
Examination of the external jugular vein to determine JVP is an appealing alternative. The external jugular vein is easier to visualize and studies have demonstrated that this is a reliable method that correlates highly with catheter measured CVP.
- Conditions
- Central Venous Pressure
- Being tested
- Non-Invasive Central Venous Pressure monitor, Physical examination of jugular vein
- Keywords
- Central Venous Pressure, Kidney Diseases, Chronic Kidney Disease, Healthy Subjects, Non-Invasive Monitor
- Medical subject headings
- Kidney Diseases, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive Central Venous Pressure monitorDevice
Also called NICVP monitor
An adhesive patch (connected to the Mespere NICVP monitor) is placed on the neck of the subject, to determine if the CVP values displayed by the device correlates with CVP values obtained by physical examination (standard clinical practice)
Physical examination of jugular veinProcedure or surgery
Physicians assess CVP using the jugular vein of the subject
| Study group | Role | What they receive |
|---|---|---|
| Chronic Kidney Disease | minimum 7 subjects (male and female) Receives: Device: Non-Invasive Central Venous Pressure monitor; Procedure: Physical examination of jugular vein | |
| Healthy subjects | minimum 3 subjects (male and female) Receives: Device: Non-Invasive Central Venous Pressure monitor; 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 physical examination
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 posted18 Nov 2010 (estimated)
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mespere Lifesciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- St. Joseph's Healthcare Hamilton
- Responsible party
- Sponsor
- Investigators
- Azim S Gangji, MD, Principal investigator, St. Joseph's Healthcare HamiltonMelissa T Perri, MESc, Study director, Mespere Lifesciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243515
- Sponsor's protocol ID
- MLS STP-9000006
- Status last verified
- Feb 2013
- First submitted
- 17 Nov 2010
- 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
- Clinical Validation of a Non-Invasive Central Venous Pressure Device in Comparison With Physical Examination in Patients With Chronic Kidney Disease and Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01243515
- Acronym / sponsor ID
- MLS STP-9000006
- Conditions
- Central Venous Pressure
- Keywords
- Central Venous Pressure, Kidney Diseases, Chronic Kidney Disease, Healthy Subjects, Non-Invasive Monitor
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mespere Lifesciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- St. Joseph's Healthcare Hamilton
- First posted
- 18 Nov 2010 (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 primary objective of this study is to determine whether a correlation exists between the Mespere Non-Invasive Central Venous Pressure (NICVP) device for measuring central venous pressure (CVP), and assessment of CVP via physical examination.
Detailed description
The estimation of central venous pressure (CVP) is part of routine clinical examination. Central venous pressure is the indication of the pressure in the right atrium of the heart and it can be measured by determining the height of the blood column in the internal or external jugular vein. Clinical use of CVP has a wide range of applications including diagnosis of heart failure, pleural effusion, hypervolemia, hypovolemia, and sepsis. The standard clinical method for attaining CVP non-invasively is the physical examination of jugular venous pulse (JVP). The JVP provides a useful estimate of the CVP.
It is often difficult to identify the internal jugular vein to determine the JVP. The internal jugular vein is deep and adjacent to the carotid artery and pulsations derived from the artery may obscure the subtle venous pulsations. Manoeuvres to differentiate carotid pulsation and jugular pulsation are helpful in identifying the internal jugular vein, however determining the JVP based on the internal jugular vein examination is difficult.
Examination of the external jugular vein to determine JVP is an appealing alternative. The external jugular vein is easier to visualize and studies have demonstrated that this is a reliable method that correlates highly with catheter measured CVP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Kidney Disease | – | Device: Non-Invasive Central Venous Pressure monitor, Procedure: Physical examination of jugular veinminimum 7 subjects (male and female) |
| Healthy subjects | – | Device: Non-Invasive Central Venous Pressure monitor, Procedure: Physical examination of jugular veinminimum 3 subjects (male and female) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with Chronic Kidney Disease (CKD)
Key inclusion criteria (4 listed)
- Age 18 years or older at the time of enrolment
- Chronic Kidney Disease patients and healthy volunteers
- Participants should be able to provide written informed consent
- Subject is termed eligible as determined by Pre-Screening Phase (as defined in protocol)
Key exclusion criteria (7 listed)
- Unable to identify external jugular vein (EJV)
- Unable to identify internal jugular vein (IJV)
- Unable to access right side of subject's neck
- Allergic to adhesive tape
- History of central vein stenosis
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 |
|---|---|---|
| Non-Invasive Central Venous Pressure monitorAlso: NICVP monitorAn adhesive patch (connected to the Mespere NICVP monitor) is placed on the neck of the subject, to determine if the CVP values displayed by the device correlates with CVP values obtained by physical examination (standard clinical practice) | Device | Chronic Kidney Disease, Healthy subjects |
| Physical examination of jugular veinPhysicians assess CVP using the jugular vein of the subject | Procedure or surgery | Chronic Kidney Disease, Healthy subjects |
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 physical examination
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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.
Azim S Gangji, MD principal investigator
St. Joseph's Healthcare Hamilton
Melissa T Perri, MESc study director
Mespere Lifesciences Inc.
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 Canada.
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 4 inclusion and 7 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: withdrawn, 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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.