跳至主要内容
临床试验/NCT02977546
NCT02977546已完成不适用

Noninvasive Pulse Contour Analysis for Hemodynamic Assessment in Patients With Chronic Heart Failure

Heart and Diabetes Center North-Rhine Westfalia1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
107
试验地点
1
主要终点
Cardiac Output (l/min)

研究概览

简要总结

Determination of hemodynamics plays an important role in the diagnosis of chronic heart failure. The gold standard is intermittent thermodilution via pulmonary artery catheter (PAC). Because of its invasiveness, there are certain risks of this method, e.g. injuries to the nerves and vessels, excessive bleedings, pneumothorax, cardiac arrhythmias etc. Noninvasive pulse contour Analysis (NPCA) is a new method which is able to determine hemodynamics noninvasively via a simple finger cuff. Advantages towards pulmonary artery Catheterization include a lower risk and an operator-Independent easy handling. Some studies investigated the accuracy, precision and trending abilities of noninvasive pulse contour analysis during anesthesia and in the intensive care unit, but there is no data available for its use in patients with chronic heart failure. The investigators therefore initiated this Trial to verify if NPCA is suitable for Determination of hemodynamics in patients with chronic heart failure.

详细描述

Determination of hemodynamics plays an important role in the diagnosis of chronic heart failure. The gold standard is intermittent thermodilution via pulmonary artery catheter (PAC). Because of its invasiveness, there are certain risks of this method, e.g. injuries to the nerves and vessels, excessive bleedings, pneumothorax, cardiac arrhythmias etc. Noninvasive pulse contour Analysis (NPCA) is a new method which is able to determine hemodynamics noninvasively via a finger cuff. Advantages towards pulmonary artery Catheterization include a lower risk and an operator-Independent easy handling. Some studies investigated the accuracy, precision and trend abilities of noninvasive pulse contour analysis during anesthesia and in the intensive care unit, but there is no data for its use in patients with chronic heart failure. The investigators therefore initiated this Trial to verify if NPCA is suitable for Determination of hemodynamics in patients with chronic heart failure. For NPCA the investigators use the CNAP monitor (CNSystems Medizintechnik AG). As a reference method the investigators use intermittent thermodilution via PAC (TD). Three averaged autocalibrated NPCA-CO-measurements are going to be validated against three averaged TD-CO-measurements. Moreover, measurements of cardiac index, stroke volume, systemic vascular resistance and a between-calibration-drift will be performed. The investigators will assess the accuracy and precision of the individual values.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • chronic heart failure NYHA >= 2 based on a reduced left ventricular ejection fraction (LV-EF <= 45%)
  • written consent

排除标准

  • high-grade tricuspid insufficiency
  • implantation of a ventricular assist device (VAD)
  • NIBP difference >= 20 mmHg between left and right arm before investigation

结局指标

主要结局

Cardiac Output (l/min)

时间窗: 1 day

Three repeated and averaged measurements in a row of both methods within a range of \<= 10%

次要结局

  • Stroke volume (ml)(1 day)
  • Systemic vascular resistance (dyn*sec/cm5)(1 day)
  • Cardiac index (l/min/m2)(1 day)

研究者

发起方
Heart and Diabetes Center North-Rhine Westfalia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Bitter

Principal Investigator, Consultant for Cardiology and Pneumology, Doctor of medicine

Heart and Diabetes Center North-Rhine Westfalia

研究点 (1)

Loading locations...

相似试验