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

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.

Study Overview

• Status: Withdrawn
• Conditions: Central Venous Pressure
• Intervention / Treatment: 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 Type: Observational

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Hamilton Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with Chronic Kidney Disease (CKD)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central Venous Pressure (CVP)	To determine if the CVP from the non-invasive monitor correlates with the CVP from physical examination	0-3 hours

Collaborators and Investigators

• Sponsor: Mespere Lifesciences Inc.
• Collaborators: St. Joseph's Healthcare Hamilton
• Investigators: Principal Investigator: Azim S Gangji, MD, St. Joseph's Healthcare Hamilton; Study Director: Melissa T Perri, MESc, Mespere Lifesciences Inc.

Study record dates

Study Registration Dates

• First Submitted: November 17, 2010
• First Submitted That Met QC Criteria: November 17, 2010
• First Posted (Estimate): November 18, 2010

Study Record Updates

• Last Update Posted (Estimate): February 8, 2013
• Last Update Submitted That Met QC Criteria: February 7, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; Kidney Diseases; Healthy Subjects; Central Venous Pressure; Non-Invasive Monitor
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: MLS STP-9000006