A Prospective Trial of Nonconvulsive Electrographic Seizure Detection by Nurses in the Adult Neuro ICU Using a Panel of Quantitative EEG Trends
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Sensitivity of nurses ability to detect recurrent NCS on QEEG
研究概览
简要总结
This research is being conducted to determine if Neuroscience intensive care unit (ICU) nurses are able to identify seizures by reviewing quantitative EEG (qEEG) that is running at the bedside. QEEG is the application of mathematical and analytical techniques to analyze EEG signals. Several hours of data can be displayed on a single screen in several graphical panels. Routine evaluation of EEG data consists of manual inspection of each page of EEG data by a trained neurophysiologist (a neuro ICU doctor) and can be quite time-consuming. In most cases, this data can only be reviewed intermittently and interpretation is almost always relayed to the primary clinical team after the seizures have occurred. Theoretically,qEEG graphical displays can provide a simplified view of complex EEG data that could possibly be used by non-neurophysiologists, such as Neuro ICU nurses. Our hypothesis is that Neuro ICU nurses are able to accurately identify recurrent seizures in real-time.
详细描述
PROTOCOL TITLE A prospective trial of nonconvulsive electrographic seizure detection by nurses in the adult Neuro ICU using a panel of quantitative EEG trends
PURPOSE OF STUDY The primary objective of this prospective study is to determine the sensitivity and specificity of quantitative EEG (qEEG) trends in the identification of recurrent nonconvulsive electrographic seizures by non-neurophysiologists in adult patients admitted to the Duke Neuro Intensive Care Unit (Neuro ICU). Our hypothesis is that bedside Neuro ICU nurses using a panel of qEEG trends can identify recurrent nonconvulsive seizures (NCS) with adequate sensitivity and specificity.
Secondary objectives include identifying seizure and EEG characteristics that make NCS more or less likely to be detected on qEEG. These characteristics include average seizure duration, spatial extent of the seizure (focal, hemispheric or bilateral/generalized) and the EEG background (periodic vs. non-periodic and epileptiform vs. non-epileptiform).
PRINCIPLE INVESTIGATOR Dr. Saurabh R. Sinha MD, will be the principal investigator (PI) on this project and is responsible for the study design, generation and analysis of data, presentation of reports, and protection of human subjects in the performance of the clinical investigation. His contact information is provided below.
Saurabh R. Sinha, M.D. 295 Hanes House, 330 Trent Drive. Box 102350 Duke University Medical Center. Durham, NC 27710. Phone: 919-684-8485. Fax: 919-684-8955. Email: saurabh.sinha@duke.edu
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 years or older at time of consent
- •Patients undergoing cEEG monitoring to evaluate for the presence of NCS
- •Admission or pending transfer to the adult Neuro ICU
- •Informed consent by patient or patient's legally authorized representative (LAR)
- •One or more NCS identified on cEEG monitoring, confirmed by the clinical neurophysiology team
排除标准
- •Anticipated discharge from NICU < 24 hours
- •Anticipated duration of cEEG monitoring < 24 hours
- •Suspected diagnosis of brain death
- •Open head wound or bandage preventing application of majority of EEG electrodes
- •Treating physician deems not appropriate for subject participation
- •Seizures lasting more than 1 hour in duration
- •Convulsive seizures without concern for NCS
结局指标
主要结局
Sensitivity of nurses ability to detect recurrent NCS on QEEG
时间窗: within 3 months after patient enrollment
Neuro ICU nurses will be asked to check the qEEG screen hourly and record the number of seizures (similar in appearance to the sentinel seizure qEEG print out) seen on the qEEG display. At one hour intervals the nurse will mark one of the following options: no seizures, 1-2 seizures, 3-5 seizures, 6-10 seizures or \>10 seizures. The total duration of the study will be for 24 hours or when the treating physician discontinues continuous EEG monitoring, whichever is shorter. After completing enrollment, board-certified neurophysiologists and study authors (SS and CS) will review the raw EEG data independently to identify seizures. Each hour of raw EEG will be placed into the follow categories: no seizures, 1-2 seizure, 3-5 seizures, 6-10 seizures or \>10 seizures. Standard test characteristics (sensitivity, specificity, ect) will be calculated comparing the nurses responses to the gold standard of raw EEG review.
次要结局
- Specificity of nurses ability to detect recurrent NCS on QEEG(Within 3 months of patient enrollment)