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

Central Venous Pressure Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01243515
• Other study ID #: MLS STP-9000006
• Status: Withdrawn
• Phase: N/A
• First received: November 17, 2010
• Last updated: February 7, 2013

Study information

• Verified date: February 2013
• Source: Mespere Lifesciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Central Venous Pressure
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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)

Procedure:
• Physical examination of jugular vein
Physicians assess CVP using the jugular vein of the subject

Locations

Country	Name	City	State
Canada	St. Joseph's Hamilton Healthcare	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Mespere Lifesciences Inc.	St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central Venous Pressure (CVP)	To determine if the CVP from the non-invasive monitor correlates with the CVP from physical examination	0-3 hours	No