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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Brief Summary

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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.

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Detailed Description

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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

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Central Venous Pressure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic Kidney Disease

minimum 7 subjects (male and female)

Non-Invasive Central Venous Pressure monitor

Intervention Type DEVICE

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 vein

Intervention Type PROCEDURE

Physicians assess CVP using the jugular vein of the subject

Healthy subjects

minimum 3 subjects (male and female)

Non-Invasive Central Venous Pressure monitor

Intervention Type DEVICE

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 vein

Intervention Type PROCEDURE

Physicians assess CVP using the jugular vein of the subject

Interventions

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Non-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)

Intervention Type DEVICE

Physical examination of jugular vein

Physicians assess CVP using the jugular vein of the subject

Intervention Type PROCEDURE

Other Intervention Names

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NICVP monitor

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes