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Comparison of a Non-Invasive Central Venous Pressure Device and Physical Examination in Patients With Chronic Kidney Disease

Clinical Validation of a Non-Invasive Central Venous Pressure Device in Comparison With Physical Examination in Patients With Chronic Kidney Disease and Healthy Volunteers

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01243515
Enrollment
0
Registered
2010-11-18
Start date
Unknown
Completion date
Unknown
Last updated
2013-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Venous Pressure

Keywords

Central Venous Pressure, Kidney Diseases, Chronic Kidney Disease, Healthy Subjects, Non-Invasive Monitor

Brief 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.

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.

Interventions

DEVICENon-Invasive Central Venous Pressure 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)

Physicians assess CVP using the jugular vein of the subject

Sponsors

St. Joseph's Healthcare Hamilton
CollaboratorOTHER
Mespere Lifesciences Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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)

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Central Venous Pressure (CVP)0-3 hoursTo determine if the CVP from the non-invasive monitor correlates with the CVP from physical examination

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026