Appraisal of the Exactness of a Method to Semiinvasively Evaluate the Cardiac Output of ICU-Patients Through the Use of the Pulsioflex Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Bias of proAQT measurement
研究概览
简要总结
Goal of the Study is to Study the precision of semi-invasive cardiac index monitoring by means of the ProAQT (PULSION Medical Systems SE) sensor, whereby the pulmonary artery catheter will serve as gold standard.
详细描述
Goal of the Study is to Study the precision of semi-invasive cardiac index monitoring by means of the ProAQT (PULSION Medical Systems SE) sensor, whereby the pulmonary artery catheter will serve as gold standard.
Measurements will be performed contemporaly with both devices every 4 hours and all clinical and hemodynmaic parameters will be recorded, including but not limited to central venous pressure, wege pressure, mechanical ventilation pressures, blood pressures, volume balance as well as vasoaktive medikation doses. This precise evaluation shall serve to evaluate the precision of the ProAQT to estimate the cardiac index under different clinical situation in the intensive care unit. A precision difference of below 30% between both methods will be regarded as clinically irrelevant, suggesting equipoise between both methods.
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
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In situ pulmonary artery catheter
- •Above 16 years of age
- •At least 36 hours of continuous hemodynamic monitoring with the pulmonary artery catheter planed
排除标准
- •Patients with:
- •Permanent or pesisting Atrial Fibrilation or Ventricular Arrythmias
- •Moderate to Severe Aortic Insuficiency or Aortic Stenosis
- •Intravascular Cardiac Assist Device
- •Planed removal of the pulmonary artery catheter <36 hours
结局指标
主要结局
Bias of proAQT measurement
时间窗: 51 Hours
Bias between the Pulsion CI measurement and the gold standard CI measurement by Pulmonary artery catheterisation
次要结局
- Percentage Error of CI Measurement(51 Hours)
