Electrographic Seizure Management and Neurobehavioral Outcomes in Critically Ill Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Electrographic Seizure Occurrence
研究概览
简要总结
Electrographic seizures are common in critically ill patients leading to increased use of resource-intense continuous EEG monitoring for seizure identification and management. When identified, electrographic seizures are generally treated with anti-seizure medications, but there are very limited data available regarding optimal treatment in terms of the efficacy or safety of specific anti-seizure medications or overall management strategies.
This is a single-center prospective observational study. The investigators aim to: (1) track critically ill patients undergoing clinically indicated EEG monitoring and seizure management to identify risk factors for electrographic seizures, (2) create prediction models guiding EEG monitoring resources to the patients at highest risk for seizures, and (3) evaluate our current management strategy in terms of safety.
详细描述
Context: Electrographic seizures are common in critically ill patients leading to increased use of resource-intense continuous EEG monitoring for seizure identification and management. When identified, electrographic seizures are generally treated with anti-seizure medications, but there are very limited data available regarding optimal treatment in terms of specific medication selections or overall management strategies. The Children's Hospital of Philadelphia (CHOP) has a formal ICU EEG Monitoring Pathway aiming to standardize EEG monitoring and seizure management. This is a single-center prospective observational study of patients undergoing clinically indicated EEG monitoring to identify risk factors for electrographic seizures and create prediction models guiding limited EEG monitoring resources to the patients at highest risk for seizures, and also to evaluate the current seizure management strategy in terms of safety.
Objectives: The primary objective is to identify risk factors for electrographic seizures in critically ill patients and use these risk factors to create and validate a seizure prediction model. The secondary objective is to evaluate the safety of a targeted and timely electrographic seizure identification and management strategy among critically ill patients guided by a CHOP ICU EEG Monitoring Pathway.
Study Design: Single center observational study of consecutive patients undergoing clinically indicated EEG monitoring.
Setting/Participants: Single-center study of critically ill children in the Pediatric ICU at CHOP undergoing clinically indicated EEG monitoring and seizure management.
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
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Care in the Children's Hospital of Philadelphia Pediatric ICU.
- •Clinically indicated continuous EEG monitoring.
- •Age > 1 month to 18 years.
排除标准
- •Admitted for Phase 2 (intracranial) EEG monitoring.
- •Intensivist expects to discontinue technological support in the next two days given underlying medical or neurological problems.
研究组 & 干预措施
Cohort
Critically ill child undergoing clinically indicated EEG monitoring and electrographic seizure management.
干预措施: Clinically indicated EEG monitoring. (Other)
结局指标
主要结局
Electrographic Seizure Occurrence
时间窗: 3 days
Percentage of subjects who experience electrographic seizures.
次要结局
- Safety -Occurrence of Hospital Acquired Infections(5 days)
- Safety - Mortality(5 days)
- Safety - Occurrence of Cardiopulmonary adverse effects(5 days)
- Safety - Occurrence of Organ Dysfunction(5 days)