跳至主要内容
临床试验/NCT03076983
NCT03076983已完成不适用

Assessment of the Capability of PulmoVista 500 to Continuously Monitor Changes of Ventilation Over Time

Drägerwerk AG & Co. KGaA3 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
3
主要终点
Monitoring Capabilities of PulmoVista 500

研究概览

简要总结

The results of this study will help to define the capability and reliability of PulmoVista 500 to detect changes in both global and regional ventilation.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Monitoring Capabilities of PulmoVista 500

时间窗: Day 1

The cross-correlation between the volume curve of the ventilator and the global impedance curve of PulmoVista 500 was expressed by the cross-correlation coefficient R. The cross-correlation coefficient is a measure to quantify the relationship between the volume curve and the EIT curve. The correlation coefficient R can assume values between \[-1, 1\] to describe the relationship between the two curves, as is usual for a correlation. To calculate the correlation coefficient, a phase shift between the two curves was taken into account, so the cross-correlation between them was calculated. The phase shift or delay occurs when the signal from the fan is transmitted to the PulmoVista500. The cross-correlation coefficient is determined by calculating the correlation coefficient for the curves within a narrow range of Lags(-15 to 15 ) for each pair of curves and using the maximum value as the value of correlation coefficient (therefore it is called cross-correlation coefficient)

次要结局

  • Assessing the Use Specific Clinical Helpfulness of PulmoVista 500 by Particular Questionnaire. The Questions Which Were Asked Within the Questionaire Are Listed in the "Outcome Measure Description"(Day 1)
  • Detection of Changes in Regional Ventilation(Day 1)
  • Assess Changes of Tidal Volumes(Day 1)
  • Safety - Documentation of Any Safety Events(Day 1)
  • Assess Changes of the End-expiratory Lung Volumes(Day 1)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (3)

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