跳至主要内容
临床试验/NCT02444104
NCT02444104Unknown不适用

Validation of Non-invasive Blood Pressure and Cardiac-output Measurement by Using Applanation Tonometry in Cardiological Patients

Universitätsklinikum Hamburg-Eppendorf1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Accuracy and precision of blood pressure and cardiac output by applanation tonometry

研究概览

简要总结

To evaluate and to validate accuracy, precision and trending ability of blood pressure and cardiac output measurement by applanation tonometry in cardiological patients having:

  • atrial fibrillation
  • severe impaired leftventricular function
  • severe aortic valve stenosis
  • patients having left ventricular assist device

Experimental measurement: continuous blood pressure measurement and cardiac output measurement is performed by the T-Line 200 pro device (Tensys Medical Inc., San Diego, USA) Control measurement: gold-standard continuous blood pressure measurement is performed by invasive blood pressure measurement by arterial cannulation and cardiac output reference is assessed by transcardiopulmonary thermodilution

详细描述

Increasing complexity of medical interventions and critical care treatment in an elderly getting population requires precise and accurate hemodynamic monitoring.(1) However, advanced invasive hemodynamic monitoring is often combined with complications by arterial or central venous catheterization. Complications such as vessel harming, infection, cardiac arrhythmias and nervous lesions are likely to occur.(2-4) Therefore, in the past various techniques of minimal- or non-invasive hemodynamic monitoring devices have been evaluated.(5, 6) One of the very promising technique is continuous non-invasive blood pressure monitoring by applanation tonometry. Published data revealed efficacy of this technique. (7) However, ability of this technique remains unclear in patients suffering from cardiological pathologies leading to changing stroke volumes as in arterial fibrillation, to highly reduces stroke volume as in severe impaired left-ventricular function or in severe aortic valve stenosis. Further, ability of applanation tonometry in patients without having pulsatile blood flow such as in patients with left-ventricular assist device remains unclear. Therefore, validation of this technique should be performed in the presented study.

Further development of applanation tonometry including pulse contour analysis now enables assessment of cardiac output. However, till now there is limited data assessing validation cardiac output measurement by this method. Cardiac output validation should also be performed in the planed clinical study.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • atrial fibrillation
  • severe impaired leftventricular function
  • severe aortic stenosis
  • LVAD Patients

排除标准

  • Age <18 years
  • pregnancy
  • patients having blood pressure difference of more than 10 mmHg on both arms (measurement by "Riva-Rocci" before study enrolment)
  • pre-existing on arterial vessels of the arms
  • patients who are not able to give informed consent

结局指标

主要结局

Accuracy and precision of blood pressure and cardiac output by applanation tonometry

时间窗: 30 minutes

次要结局

  • Trending ability of blood pressure monitoring by applanation tonometry(30 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验