Observational Single-Center Study: Improving Timely Detection of Electrographic Seizures by Use of Rapid-Response EEG in Children With Suspected Status Epilepticus Admitted to the Pediatric ICU
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time from order of electroencephalogram (EEG) to EEG reading
研究概览
简要总结
Seizures are common in children (~350 per 100,000 patients per year) and require immediate medical attention. If the seizure is prolonged (> 5 minutes) it is called status epilepticus and delayed treatment leads to higher risk in drug resistance and brain injury. The current standard of care for children admitted to the ICU with established or suspected status epilepticus is to start a conventional continuous EEG study that helps diagnosing seizures by typical electro graphic patterns. It takes on average 4 hours to start and another two hours to obtain a reading by epileptologists. This is far beyond the time window of starting an EEG study (60 minutes) as recommended by the neurocritical care society. In adult ICUs, point of care "Rapid Response EEG" are becoming a new standard of care and our ICU adopted this practice in 2020. It can be easily placed by the ICU staff rather than a specifically trained EEG technician but has a lower resolution due to fewer leads (10 vs. 20). The purpose of this study is to determine wether and by how much time RR-EEG yields faster preliminary EEG reports that the previously available conventional EEG (cEEG) and wether the detection of electro graphic seizures is comparable. This is a retrospective cohort study following patients who are admitted to the PICU and are placed on either cEEG or RR-EEG for status epilepticus.
详细描述
The primary aim of this study is to investigate by how much faster EEG results can be obtained using the Ceribell® Rapid Response EEG (RR-EEG) device (CERIBELL, INC., Sunnyvale, CA) as compared to conventional continuous 20-channel EEG (cEEG). The study is conducted in a single urban academic pediatric hospital 26-bed ICU as a retrospective cohort study by chart review of pediatric patients who either underwent conventional continuous EEG (cEEG) or rapid response EEG (RR-EEG) as their first EEG study within 24 hours of admission. The indication for an EEG study was determined by the treating ICU team based on the suspicion of status epilepticus and the choice of EEG modality was at the primary physician's discretion. This retrospective study was approved with a waiver for consent by the Institutional Review Board at Albert Einstein College of Medicine (IRB # 2021-13666).
Subjects:
Pediatric patients (0-21 years) primarily admitted to the pediatric ICU (PICU) with a neurological diagnosis, diminished level of consciousness, and established or suspected status epilepticus are included. Exclusion criteria are rapid neurological improvement, traumatic brain injury and incomplete (<1 hour recorded) EEG data.
The investigators will query all studies on Natus® (Middleton, WI) NeuroWorks® (cEEG) and the online Ceribell® portal (RR-EEG) to review continuous EEG studies between January and December 2020 to capture patients admitted to PICU with complete EEG data. Through chart review the investigators verified that EEG studies were started within 24 hours of admission. If the numbers obtained aren't sufficient (see statistics section) the data collection will be expanded to include the years 2021-2022.
The primary outcome is times from EEG order to first EEG report. The time of EEG order will be used as a surrogate for the treatment team's decision to obtain an EEG. Data collection also includes covariables that could potentially affect the primary outcome (potential confounders) based on patient factors (age, sex, race, head circumference, known epilepsy, baseline pediatric Glasgow Outcomes Score Extended [GOS-E Peds] and comorbidities), clinical factors (witnessed clinical seizures, decreased level of consciousness, Glasgow Coma Scores, admission diagnosis, neurological diagnosis and Paediatric Index of Mortality score Version 2 [PIM-2]) and management factors (intubation, imaging obtained, procedures performed in the ICU, rate of admission during normal business hours). These data will be collected to address potential bias in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients with suspected status epilepticus as determined by the treating team in the pediatric ER or ICU
排除标准
- 未提供
结局指标
主要结局
Time from order of electroencephalogram (EEG) to EEG reading
时间窗: up to 24 hours
EMR order placement as a surrogate for decision making to obtain an EEG. Report time of EEG was considered the time relevant information was available to the ICU team.
次要结局
- EEG description(up to 24 hours)
- Time from EEG order to start of EEG recording(up to 24 hours)
- Time from EEG start to first EEG reading report as documented in the electronic medical record(up to 24 hours)