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临床试验/NCT06544148
NCT06544148招募中不适用

Non-Invasive Measurements of Changes in Pulmonary Artery Pressure in Intensive Care Unit Patients Using Electrical Impedance Tomography - A Feasibility Study (PAP-EIT Study)

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2024年8月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
28
试验地点
1
主要终点
Mean difference between EIT-derived and PAC-measured changes in pulmonary artery pressure

研究概览

简要总结

To assess whether changes in electrical impedance - measured using an electrical impedance tomography (EIT) chest belt - can be used to derive changes in pulmonary artery pressure (PAP) in critically ill patients when compared to invasive gold-standard PAP measured using pulmonary artery catheter (PAC).

研究设计

研究类型
Observational
观察模型
Case Control
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

Mean difference between EIT-derived and PAC-measured changes in pulmonary artery pressure

时间窗: Up to 48 hours

The primary outcome is the difference - expressed as mean and standard deviation (SD) - between changes in EIT-derived pulmonary artery pressure (ΔPAP_EIT), derived from changes in the pulmonary pulse arrival time, and changes in pulmonary artery catheter-based pulmonary artery pressure (ΔPAP_PAC). This will be measured over recording periods of up to 48 hours.

次要结局

  • Data acceptance rate(Up to 48 hours)
  • Accuracy and trending ability of EIT-derived cardiac output compared to PAC measurements(Up to 48 hours)
  • Concordance rate (%) of directional changes in pulmonary artery pressure between EIT and PAC measurements (Trending ability)(Up to 48 hours)
  • Agreement between EIT-derived and ventilator-measured respiratory parameters(Up to 48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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