Combined Amplitude-integrated and Conventional EEG Monitoring in High-risk Critically Ill Neonates: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Number of seizures detected
研究概览
简要总结
Over the past decade, technical advances have improved the efficiency of continuous EEG recording and remote review, leading to a steep increase in the number of continuous EEGs performed, and to an emerging change in what is considered the standard of care with regards to brain monitoring. Critically ill patients are at high risk for CNS insults, which can result in permanent neurologic disability if untreated. Non-convulsive status epilepticus and other secondary brain injuries are often unrecognized without continuous EEG monitoring. There is increasing evidence that continuous EEG monitoring facilitates early identification and management of changes in brain function, and a recent consensus statement concludes that "each center should provide critical care continuous EEG at the highest level that local resources allow". Neonatal neuro-intensive care is a rapidly developing field with a focus on monitoring of the developing brain. Without continuous EEG monitoring, neonates with paroxysmal events that are suspicious for seizures are treated with phenobarbital, often for many months, with inherent risks of side effects. Because paroxysmal events in neonates may or may not represent seizures, and electrographic seizures may have no discernable clinical correlate, this approach fails to adequately diagnose seizures and exposes neonates to possible harm, either by medication overuse for paroxysmal events that have no electrographic correlate, or by under-treatment of seizures without clinical manifestations. Amplitude-integrated EEG technology is now increasingly used as a simplified monitoring method, using fewer numbers of electrodes and usually being interpreted by a neonatologist or trainee. This model has been implemented at the investigators NICU. However, a recent systematic review came to the conclusion that amplitude-integrated EEG has relatively low and variable sensitivity and specificity, and therefore should not be the mainstay for diagnosis and management of neonatal seizures. Continuous video EEG monitoring is recommended as the gold standard for critically ill neonates, but is a very expensive and resource-intense method. An approach combining both techniques in a standardized algorithm may provide improved patient care in a resource-restricted environment. The investigators are planning to test this hypothesis in a pilot project.
详细描述
HYPOTHESIS
An algorithm combining conventional and amplitude-integrated EEG monitoring will increase specificity and sensitivity of seizure detection in critically ill high-risk neonates in a resource-restricted environment.
OBJECTIVES
- To describe the sensitivity and specificity of amplitude-integrated EEG (aEEG) relative to conventional EEG (cEEG) monitoring in high-risk critically ill neonates
- To evaluate the feasibility of an algorithm combining amplitude-integrated and conventional EEG monitoring in high-risk critically ill neonates
Long-term Objectives
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
入排标准
- 年龄范围
- 1 Day 至 6 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates admitted to our NICU
- •Neonates identified to require aEEG monitoring as per current NICU guidelines (all neonates receiving therapeutic hypothermia as well as neonates with clinical events suggestive of seizures)
排除标准
- •Neonates not eligible for EEG monitoring (e.g. patients with extensive cephalhematoma or subgaleal hemorrhage, interfering with the application of electrodes)
结局指标
主要结局
Number of seizures detected
时间窗: Through study completion, an average of 3 days
1. Number of seizures detected via conventional, but not amplitude-integrated EEG 2. Number of seizures detected via amplitude-integrated EEG that in fact were not seizures on interpretation via conventional EEG
次要结局
- Number of events providing treatment-relevant information(Through study completion, an average of 3 days)
