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临床试验/NCT03138876
NCT03138876已完成不适用

EEG Cap Placement for Expedited Identification of Non-Convulsive Status Epilepticus

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年5月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
20
试验地点
1
主要终点
Time Difference Between EEG Cap and Standard EEG Results Reporting

研究概览

简要总结

Altered mental status (AMS) is one of the most common reasons for inpatient neurology consultation. Non-convulsive status epilepticus (NCSE) is frequently on the differential diagnosis of the patient with AMS. NCSE becomes more refractory to treatment after one hour of seizure activity, making rapid identification and treatment of NCSE of great clinical importance. Currently, an electroencephalogram (EEG) technologist must be called in from home during non-workday hours in order to obtain a stat EEG. The investigators propose the time required for diagnosis of NCSE at Mayo Clinic can be significantly decreased with rapid placement of an EEG cap by the onsite neurology residents.

详细描述

At the completion of neurology evaluation, if NCSE is in the differential diagnosis according to institution best practice, then consented participants will undergo placement of a large size, 20-channel EEG cap from Electro-Cap International with a Natus E-2-2520-26 electrode board adapter with initiation of recording. The placement of the EEG cap will be restricted to residents formally trained in its placement by an EEG tech. This study will only be performed during times when EEG techs are not available onsite for rapid placement of standard 21-channel EEG electrodes, such as during night-call shifts.

Prior to placement of EEG cap, evaluating staff member will request immediate standard-electrode EEG. The investigators will record time from neurology consultation request to placement of EEG cap as well as time from consultation request to obtaining a standard EEG. The investigators will also record time to confirmation or exclusion of NCSE. Initial diagnosis or exclusion of NCSE will be performed by on call resident, if the resident received prior training regarding EEG cap placement, and attending. Secondary quality assessment will be performed by two independent EEG interpreters blinded to clinical history. Secondary assessment will be qualified as acceptable or inacceptable interpretation based on whether greater or less than 50% of the recording is judged interpretable. Secondary assessment will also include interpretation of NCSE by a third independent reader if there is disagreement between first two. The number of patients excluded from the study will also be recorded, including the reason for exclusion.

研究设计

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

盲法说明

There will be blinded EEG assessment in terms of the EEG readers.

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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

EEG Cap

Other

Single arm study, where every participant gets assessed by EEG cap and then standard EEG. Some subjects may be treated with anti-seizure medications before standard EEG, due to ethical responsibility, if clear NCSE is identified on cap EEG. If the subject is treated with anti-seizure medication, the primary care provider will choose which medication will be given.

干预措施: EEG Cap (Device)

EEG Cap

Other

Single arm study, where every participant gets assessed by EEG cap and then standard EEG. Some subjects may be treated with anti-seizure medications before standard EEG, due to ethical responsibility, if clear NCSE is identified on cap EEG. If the subject is treated with anti-seizure medication, the primary care provider will choose which medication will be given.

干预措施: Anti-seizure medication (Drug)

EEG Cap

Other

Single arm study, where every participant gets assessed by EEG cap and then standard EEG. Some subjects may be treated with anti-seizure medications before standard EEG, due to ethical responsibility, if clear NCSE is identified on cap EEG. If the subject is treated with anti-seizure medication, the primary care provider will choose which medication will be given.

干预措施: Standard EEG (Procedure)

结局指标

主要结局

Time Difference Between EEG Cap and Standard EEG Results Reporting

时间窗: EEG order through 20 minutes of EEG recording time

The difference between EEG Cap results reporting time compared to Standard EEG results reporting time measured in minutes.

次要结局

  • Percentage of Participants Whose EEG Cap Recordings Were Interpretable(approximately 15 minutes after completion of test)
  • Number of Subjects Diagnosed With NCSE(approximately within 15 minutes after completion of test)
  • Number of Subjects for Which the EEG Cap and Standard EEG Results Are in Agreement for the Diagnosis of NCSE(approximately 24 hours after completion of both tests)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

William Tatum, DO

Professor of Neurology

Mayo Clinic

研究点 (1)

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