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临床试验/NCT02901262
NCT02901262已完成不适用

Utility of Continuous Electroencephalogram and Derived Variables in NeuroIntensive Care

Azienda Ospedaliera San Gerardo di Monza2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Number of Correct qEEG Evaluations

研究概览

简要总结

To evaluate the ability of NICU (NeuroIntensive Care Unit) staff to interpret, before and after a training period, symmetry, sedation level, seizures activities and artefact on continuous cEEG/qEEG (continuous electroencephalography/quantitative electroencephalography) tracings.

详细描述

Using a web based tool, the clinicians of the two study centers will review 24 hours of recording (raw EEG data + derived qEEG variables).

The intensivists will evaluate:

  • simmetry,
  • sedation level,
  • seizures activities and
  • artefact on continuous cEEG/qEEG tracings. The same tracings will be blindly reviewed by a certified neurophysiologist (using the app). The neurophysiologist evaluation will be considered as "reference".

The results of the evaluation will be compared (intensivists vs. neurophysiologist) in order to understand if the intensivists are able to adequately identify the pathological findings.

The study period will be:

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

入选标准

  • Intensivists wil evaluate daily qEEG recordings of:
  • Patients in coma after a traumatic/vascular event
  • Admitted to neurointensive care and
  • Recorded with continuous EEG for clinical reasons

排除标准

  • No EEG recording > 24 hours

结局指标

主要结局

Number of Correct qEEG Evaluations

时间窗: 2 months

Percentage of correct evaluation of qEEG tracings by intensivists vs. neurophysiologist. The result will be expressed as percentage of correct evaluations for each domain.

次要结局

  • Kappa Coefficient of Agreement Between Intensivists and Neurophysiologists After Training(12 months)

研究者

发起方
Azienda Ospedaliera San Gerardo di Monza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Giuseppe Citerio

NeuroIntensive Care Director

Azienda Ospedaliera San Gerardo di Monza

研究点 (2)

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