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临床试验/NCT05418634
NCT05418634已完成不适用

The Role of Point-of-care EEG in the Pediatric Emergency Department

University Children's Hospital, Zurich1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年8月24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
200
试验地点
1
主要终点
Number of participants diagnosed with SE, NCSE, and encephalitis by pocEEG

研究概览

简要总结

The researchers investigate the use of a simplified electroencephalogram (point-of-care EEG) in the pediatric emergency department for children with impaired consciousness or an ongoing epileptic seizure ("status epilepticus"). In addition, the researchers will compare the simplified EEG with the conventional EEG in the epilepsy outpatient clinic.

详细描述

Non-traumatic, acute central nervous system (CNS) disorders are amongst the most frequent emergencies in childhood. In Switzerland, CNS disorders are the top ranking presentation of critically ill children. Many pediatric neurological emergencies such as coma, acute encephalopathies with impaired consciousness or agitation, or acute focal deficits, are associated with changes of cortical electrical activity detectable by the electroencephalogram (EEG). Of particular concern are status epilepticus (SE) and non-convulsive status epilepticus (NCSE). Previous studies have shown that an EEG can yield important diagnostic information and aid in decision-making. However, conventional EEG-recordings are resource intensive (time, staff), and hardly available outside of regular working hours. Point-of-care EEG (pocEEG) has proven helpful for evaluating impaired consciousness, detecting NCSE, and monitoring therapy in ongoing SE. In a retrospective cohort study from Japan patients with impaired consciousness were diagnosed with non-convulsive seizures in pocEEG, supporting the view that pocEEG can be applied by ED physicians, even in the absence of a neurologist, and can aid the detection and treatment of non-convulsive seizures. Another study, also from Japan, reported that abnormalities were detected in 20% of patients by using pocEEG in an ED setting. The aims of this study are:

  • To prospectively assess the feasibility and utility of pocEEG for NCSE detection in children presenting with impaired consciousness in the PED
  • To evaluate the interpretation accuracy of pocEEG by pediatric emergency medicine (PEM) providers after a teaching module.
  • To compare pocEEG to the "gold standard" of simultaneously recorded conventional EEG in patients undergoing routine cEEG in the epilepsy outpatient clinics.

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
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients with unexplained impaired consciousness, suspicion of NCSE, active SE presenting to the PED
  • Informed consent of patient of parents/persons responsible, if possible, otherwise emergency situation procedure (according to national regulations for research in emergency situations)
  • Informed consent as documented by signature
  • Pediatric patients undergoing cEEG in the outpatient epilepsy clinics
  • Either suspected/ to rule out epilepsy or established diagnosis of epilepsy

排除标准

  • AMS of known etiology or another diagnosis
  • Declined informed consent
  • Failure to provide signed informed consent
  • Changes in health condition which might interfere with the EEG recording.

结局指标

主要结局

Number of participants diagnosed with SE, NCSE, and encephalitis by pocEEG

时间窗: Baseline

All patients with impaired consciousness presenting to the PED will receive a pocEEG. We analyse the number of patients with SE, NCSE, and encephalitis diagnosed by pocEEG

Agreement pocEEG vs. conventional EEG in epilepsy clinic

时间窗: Baseline

Agreement of pocEEG and cEEG findings in simultaneous tracings carried out during routine care in the epilepsy clinic.

次要结局

未报告次要终点

研究者

发起方
University Children's Hospital, Zurich
申办方类型
Other
责任方
Principal Investigator
主要研究者

Leopold Simma

PEM Attending

University Children's Hospital, Zurich

研究点 (1)

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