跳至主要内容
临床试验/NCT01243515
NCT01243515撤回不适用

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

Mespere Lifesciences Inc.1 个研究点 分布在 1 个国家开始时间: 2010年11月18日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Central Venous Pressure (CVP)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

Central Venous Pressure (CVP)

时间窗: 0-3 hours

To determine if the CVP from the non-invasive monitor correlates with the CVP from physical examination

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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