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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
St. Joseph's Healthcare Hamilton
Information provided by (Responsible Party):
Mespere Lifesciences Inc.
ClinicalTrials.gov Identifier:
NCT01243515
First received: November 17, 2010
Last updated: February 7, 2013
Last verified: February 2013
  Purpose

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 Intervention
Central Venous Pressure
Device: Non-Invasive Central Venous Pressure monitor
Procedure: Physical examination of jugular vein

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mespere Lifesciences Inc.:

Primary Outcome Measures:
  • Central Venous Pressure (CVP) [ Time Frame: 0-3 hours ] [ Designated as safety issue: No ]
    To determine if the CVP from the non-invasive monitor correlates with the CVP from physical examination


Enrollment: 0
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: NICVP monitor
Procedure: Physical examination of jugular vein
Physicians assess CVP using the jugular vein of the subject

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adult patients with Chronic Kidney Disease (CKD)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243515

Locations
Canada, Ontario
St. Joseph's Hamilton Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
Mespere Lifesciences Inc.
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.
  More Information

No publications provided

Responsible Party: Mespere Lifesciences Inc.
ClinicalTrials.gov Identifier: NCT01243515     History of Changes
Other Study ID Numbers: MLS STP-9000006
Study First Received: November 17, 2010
Last Updated: February 7, 2013
Health Authority: Canada: Health Canada

Keywords provided by Mespere Lifesciences Inc.:
Central Venous Pressure
Kidney Diseases
Chronic Kidney Disease
Healthy Subjects
Non-Invasive Monitor

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on September 22, 2014