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临床试验/NCT04815109
NCT04815109已完成不适用

Prospective Evaluation of Aggravated Sedation in COVID-19 ARDS Patients Using Electroencephalography

Goethe University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Raw data encephalography measurement

研究概览

简要总结

Sedation of severe COVID-19 disease are often complicated. We try to find a correlate for this observation by encephalographic studies.

详细描述

Sedation of critically ill ventilated coronavirus patients, continues to be a challenging issue. Also, neurological symptoms of severe COVID-19 disease have been described frequently. Difficulties in sedation of these patients have been discussed repeatedly. The aim of this study is to investigate whether an encephalographic correlate can be found. Appropriate processed encephalographic techniques have been used for anesthesia monitoring for many years.

The aim of our study is to collect unrelated processed and raw EEG data of sedated COVID-19 patients and to investigate the correlation to the necessary sedation.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Intubated ventilated patients with SARS-CoV-2 associated acute respiratory distress syndrome and sedation difficulty.

排除标准

  • Pre-existing severe cerebral brain damage and dysfunction. For example: previous medial infarction, cerebral hemorrhage, structural epilepsy.

结局指标

主要结局

Raw data encephalography measurement

时间窗: From the beginning of the measurement until the end of the examination (10 to 20 minutes).

Measurement of the brain activity detectable for the examination procedure in the surface encephalogram.

Processed encephalography measurement

时间窗: From the beginning of the measurement until the end of the examination (10 to 20 minutes).

Measurement of detectable algorithm based patient sedation score based on brain activity in the surface encephalogram.

次要结局

  • Dosage of continuously delivered opioid based analgesia.(From 90 minutes before to 10 minutes after encephalographic measurement)
  • Dosage of continuously delivered central GABA receptor active substances.(From 90 minutes before to 10 minutes after encephalographic measurement)
  • Dosage of continuously delivered central NMDA receptor active substances.(From 90 minutes before to 10 minutes after encephalographic measurement)
  • Dosage of continuously administered centrally acting alpha2 agonists.(From 90 minutes before to 10 minutes after encephalographic measurement)

研究者

发起方
Goethe University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Armin N. Flinspach

Principal Investigator

Goethe University

研究点 (1)

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