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临床试验/NCT02545816
NCT02545816Unknown不适用

A Validation Study to Compare Bispectral Index EEG Monitoring With Full EEG in Patients With an Acute Neurological Insult

Hasselt University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
A comparison between BIS derived EEG and standard full EEG

研究概览

简要总结

After any acute brain injury, a primary pathophysiological response arises, enabling the brain to develop seizures and/or a status epilepticus (SE). These are frequently reported in patients admitted to the intensive care unit (ICU) with traumatic brain injury and brain injury caused by subarachnoid or intracerebral hemorrhage. Seizures can be presented without any clinical motor signs, which are then termed as nonconvulsive, and therefore remain frequently clinically unrecognized. As such, it is of great importance that these patients are diagnosed as early as possible since the increased metabolic demand and blood flow associated with an epileptic insult may further compromise the brain at risk. Thus far, continuous EEG (cEEG) is the only clinical instrument that is able to detect the development of early epileptic activity. Unfortunately, cEEG is not available in most ICUs and is labor-intensive, expensive and difficult to interpret for non-trained physicians. Therefore, a more simple and prognostic accurate EEG device is highly warranted to detect seizures in an early stage so that patients might benefit from a specific and early treatment. A validation study in comatose patients with an acute neurological insult will be conducted to provide evidence that simplified Bispectral Index EEG monitoring has the potential to detect epileptic activity as reliable as its gold standard, full EEG monitoring. Thereby, BIS EEG monitoring could possibly be used to facilitate the prognostication and management of epileptic seizures in this patient cohort which could eventually improve the clinical outcome.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

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

  • Patients (age ≥ 18 years) admitted to the ICU with an acute neurological insult which will be sedated/ventilated (Glasgow Coma Scale (GCS) ≤ 8).
  • Ability to place BIS sensors on the forehead
  • Written informed consent form has to be obtained from the patient's next of kin and has to be reconfirmed if the patient regains consciousness

排除标准

  • Age < 18 years
  • Inability to place BIS sensors on the forehead (e.g. due to frontal decompression)

结局指标

主要结局

A comparison between BIS derived EEG and standard full EEG

时间窗: 15 minutes before or after the acquisition of standard full EEG monitoring.

Unfiltered BIS derived EEG data from 15 minutes before or after the acquisition of a full intermittent EEG will be used to compare BIS derived EEG traces with full intermittent EEG traces. These data will be (retrospectively) analyzed by experienced neurophysiologists for the presence of seizures and/or status epilepticus.

次要结局

未报告次要终点

研究者

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

prof. dr. Frank Jans

prof. dr.

Hasselt University

研究点 (2)

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