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

M

Mespere Lifesciences

Status

Withdrawn

Conditions

Central Venous Pressure

Treatments

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

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT01243515
MLS STP-9000006

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

Chronic Kidney Disease
Description:
minimum 7 subjects (male and female)
Treatment:
Device: Non-Invasive Central Venous Pressure monitor
Procedure: Physical examination of jugular vein
Healthy subjects
Description:
minimum 3 subjects (male and female)
Treatment:
Device: Non-Invasive Central Venous Pressure monitor
Procedure: Physical examination of jugular vein

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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