Clinical trial NCT01243515: Comparison of a Non-Invasive Central Venous Pressure Device and Physical Examination in Patients With Chronic Kidney Disease
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Central Venous Pressure
Keywords: Central Venous Pressure
Kidney Diseases
Chronic Kidney Disease
Healthy Subjects
Non-Invasive Monitor
Lead sponsor: Mespere Lifesciences Inc.
Sponsor class: INDUSTRY
Collaborators: name: St. Joseph's Healthcare Hamilton
First posted: 2010-11-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with Chronic Kidney Disease (CKD)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Central Venous Pressure (CVP)
timeFrame: 0-3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Hamilton Healthcare
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare Hamilton
name: Azim S Gangji, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mespere Lifesciences Inc.
name: Melissa T Perri, MESc
role: STUDY_DIRECTOR
References: