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临床试验/NCT02458820
NCT02458820已完成不适用

Prompt Diagnosis and Treatment of Subclinical Seizures After Cardiac Arrest

Children's Hospital of Philadelphia2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2015年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
2
主要终点
Average time from EEG seizure onset to seizure recognition

研究概览

简要总结

Non-convulsive seizures (NCS) following cardiac arrest are common and are associated with worse neurologic outcomes and increased mortality. More prolonged seizures (status epilepticus) are associated with worse outcomes. Earlier diagnosis and treatment of seizures may lead to earlier termination of seizures and decreased seizure burden.

This study will evaluate whether bedside intensive care unit (ICU) provider interpretation of a type of EEG called DSA EEG can be used by non-neurologists to diagnosis seizures more rapidly than continuous EEG's routinely read by neurologists.

详细描述

Acute symptomatic electroencephalographic (EEG) seizures are common in children who experience a cardiac arrest, and are associated with worse short term survival. In larger studies of critically ill children with heterogeneous acute encephalopathy etiologies, EEG seizures occur in 10-40% of monitored patients, and there is increasing evidence that high seizure burdens are associated with worse outcomes. Furthermore, status epilepticus treatment delays are associated with reduced medication efficacy for status epilepticus termination. The majority of EEG seizures in critically ill children have no clinical correlate and therefore detection requires EEG monitoring. Many institutions do not have access to continuous EEG monitoring services. Additionally, even when EEG "monitoring" is performed, data review is generally intermittent, leading to delays between seizure onset and detection.The purpose of the study is to determine the efficacy of real-time DSA pattern interpretation for the detection of seizures by bedside ICU practitioners.The primary objective of this study is to determine the whether the real-time DSA patterns interpreted by bedside ICU practitioners can decrease the time to accurate NCS detection following pediatric cardiac arrest. All subjects who receive chest compressions and have return of spontaneous circulation and are cared for the CHOP Pediatric Intensive Care Unit (PICU) will be screened. If patients meet inclusion criteria they will be approached for consent. Written informed consent will be obtained from parents/guardians. Assent will not be obtained as these children are intubated and comatose after arrest.Patients will be randomly assigned to receive standard of care, continuous EEG monitoring, versus continuous EEG monitoring plus real-time ICU provider DSA interpretation. This will go on for the duration of clinically indicated EEG monitoring.

For patients enrolled in the standard continuous EEG arm of the study, EEG will be recorded and interpreted as per standard of care. If a seizure is noted by the neurology service, the standard seizure treatment protocol will be used by the clinical team.Patients monitored with standard EEG and DSA will undergo at least hourly interpretation of DSA by the ICU bedside care provider. If the bedside care provider is concerned that there is a seizure on DSA they will contact the EEG tech on call for confirmation. If a seizure is confirmed by neurology, the standard seizure treatment protocol will be used by the clinical team.Following completion of EEG intervention arms, the patients will be followed and discharge survival and discharge Pediatric Cerebral Performance Category (PCPC) will be documented.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
2 Days 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects age > 48 hours
  • Return of Spontaneous Circulation (ROSC) for > 20 minutes after a cardiac arrest
  • Treated in the PICU
  • Clinical team ordering continuous EEG monitoring

排除标准

  • Age < 48 hours old and < 38 weeks gestational age
  • No available computers with DSA software

研究组 & 干预措施

Usual Care

No Intervention

Patients will be recorded and interpreted as per standard of care. If a seizure is noted by the neurology service, the standard seizure treatment protocol will be used by the clinical team.

DSA EEG + Usual Care

Experimental

Patients will undergo at least hourly interpretation of DSA by the ICU bedside care provider. If the bedside care provider is concerned that there is a seizure on DSA they will contact the EEG tech on call for confirmation. If a seizure is confirmed by neurology, the standard seizure treatment protocol will be used by the clinical team.

干预措施: DSA EEG (Procedure)

结局指标

主要结局

Average time from EEG seizure onset to seizure recognition

时间窗: 3 days

EEG monitoring and DSA interpretation by ICU practitioners will continue for the duration of clinically indicated EEG monitoring which will be no more than 3 days. The average time from seizure onset to seizure recognition between the EEG group and the EEG + DSA group will be compared.

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 (2)

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