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

Sponsor

Mespere Lifesciences Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01243515

Collaborator

St. Joseph's Healthcare Hamilton (Other)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Central Venous Pressure	Device: Non-Invasive Central Venous Pressure monitor Procedure: Physical examination of jugular vein

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

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Arms and Interventions

Arm	Intervention/Treatment
Chronic Kidney Disease minimum 7 subjects (male and female)	Device: 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) Other Names: NICVP monitor Procedure: Physical examination of jugular vein Physicians assess CVP using the jugular vein of the subject
Healthy subjects minimum 3 subjects (male and female)	Device: 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) Other Names: NICVP monitor Procedure: Physical examination of jugular vein Physicians assess CVP using the jugular vein of the subject

Arm

Intervention/Treatment

Chronic Kidney Disease

minimum 7 subjects (male and female)

Device: 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)

Other Names:

NICVP monitor

Procedure: Physical examination of jugular vein

Physicians assess CVP using the jugular vein of the subject

Healthy subjects

minimum 3 subjects (male and female)

Device: Non-Invasive Central Venous Pressure monitor

Other Names:

NICVP monitor

Procedure: Physical examination of jugular vein

Physicians assess CVP using the jugular vein of the subject

Outcome Measures

Primary Outcome Measures

Central Venous Pressure (CVP) [0-3 hours]
To determine if the CVP from the non-invasive monitor correlates with the CVP from physical examination

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)