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临床试验/NCT01574690
NCT01574690已完成不适用

Correlation of Physical Exam Versus Non-invasive Near-infrared Spectroscopy Versus Invasive Hemodynamic Assessment of Central Venous Pressure

Mespere Lifesciences Inc.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Central Venous Pressure (CVP)

研究概览

简要总结

The purpose of this study is to establish the accuracy of a non-invasive device that uses near infrared spectroscopy (NIRS) to estimate central venous pressure (CVP) comparing it to physical exam and invasive hemodynamic measurement via right heart catheterization (RHC).

详细描述

Estimation of volume status is crucial when making treatment decisions for heart failure patients. Volume status is often assessed clinically by estimating the CVP, which is an estimate of right atrial filling pressure, by assessing the level of jugular venous distention. This method is quick and non-invasive but can be prone erroneous measurement due to human error and limitations secondary to body habitus and anatomical variation.

RHC is a procedure used for invasive hemodynamic measurement commonly used in heart failure patients. CVP can be measured directly via RHC using a pulmonary artery catheter. It is considered the gold standard for measuring intra-cardiac filling pressures and calculation of cardiac output and pulmonary and systemic vascular resistance. The obvious downside of RHC is that is invasive, time consuming, and has many potential serious risks including vascular complication, pneumothorax, infection, arrhythmia, valvular damage, etc.

A non-invasive, quick, and accurate way to estimate central venous pressure and oximetry could benefit patient care. NIRS is an optical imaging technology that has been proposed to estimate central venous pressure non-invasively. Our intent is to determine the accuracy of NIRS in assessment of CVP using the Mespere Venus device.

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 and older
  • Heart failure patients already receiving RHC as part of their usual care
  • Signed written and informed consent

排除标准

  • Lack of patient consent
  • Presence of known anatomical shunt or AV dialysis fistula
  • Sepsis, fever
  • Anemia (Hgb < 10)
  • Allergy to adhesive tape
  • Known central vein stenosis
  • Previous cardiac transplant
  • Unable to identify external jugular vein
  • Ongoing photodynamic therapy
  • Pregnancy

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 the invasive method (via RHC) and/or the CVP from the physical exam

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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