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临床试验/NCT03653806
NCT03653806已完成不适用

Comparing the Results of a Computer Analysis Algorithm With Clinical Decisions in a Patient With Electrical Impedance Tomography Guided Ventilator Settings Regarding Optimal Positive End Expiratory Pressure and Inspiratory Pressure

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年11月21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
40
试验地点
1
主要终点
develop automated EIT data algorithm for PEEP setting

研究概览

简要总结

First: to develop a computerized algorithm for automated analysis of the electrical impedance tomography (EIT) data. The algorithm calculates the "optimal" positive end-expiratory pressure (PEEP) and inspiratory pressure defined as the "optimal" balance between stretch, ventilation distribution and collapse.

Second: to compare the results of the algorithm with the current standard of care clinical judgement of an experienced ventilation practitioner.

详细描述

The study will be performed at the Intensive Care Unit, Maastricht University Medical Centre. The investigators routinely apply EIT (Pulmovista, Dräger, Lübeck. Germany) in mechanically ventilated patients to optimize the ventilator settings .

An algorithm will be developed by the Institute of Technical Medicine, Furtwangen University, Germany. The algorithm will automatically detect changes in both PEEP and inspiratory pressures. For each PEEP step and/or changes in inspiratory pressure the difference in regional alveolar overdistension and alveolar collapse will be calculated. This makes it possible to select the optimal ventilator setting depending on the best compromise between alveolar overdistension and alveolar collapse.

The algorithm will be tested in 40 EIT guided mechanically ventilated patients. EIT measurements will be performed during an incremental and decremental PEEP trial. The EIT measurement will be performed in the same way as during standard clinical care. EIT data will be analysed offline by a ventilation practitioner with experience in EIT and with the newly developed algorithm. The resulting advice on optimal ventilator settings will be compared for inter-observer variability.

研究设计

研究类型
Observational
观察模型
Other
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
否

入选标准

  • •Mechanically ventilated in a volume or pressure controlled mode
  • •ventilator settings guided by EIT

排除标准

  • •Participants who specifically opt-out regarding the use of the data for research purpose
  • •Internal pacemaker, Implantable Cardioverter Defibrillator
  • •Skin lesions, dressings at the thorax, hindering belt placement
  • •Thoracic circumference < 70 cm
  • •Thoracic circumference > 150 cm
  • •BMI > 50

结局指标

主要结局

develop automated EIT data algorithm for PEEP setting

时间窗: 4 months

The automated algorithm will give an advise on PEEP and delta pressure settings, based upon the EIT data, which is in accordance with the decision of the investigator

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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