跳至主要内容
临床试验/NCT05259891
NCT05259891已完成不适用

CAPTURE:eegCap Application in Paediatrics wiTh redUced GCS in REsus

University College Cork1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年7月5日最近更新:
适应症

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
The percentage of children who had EEG monitoring applied within twenty minutes and obtainment of an interpretable EEG recording with less than 25% artefact.

研究概览

简要总结

Children frequently present with altered or reduced consciousness levels to emergency departments. By using EEG monitoring, subclinical seizure activity may be detected, leading to earlier pharmacological intervention and improved outcomes. Post-ictal phases that may be interpreted as seizure activity may become less over-treated. A feasibility study will ascertain if EEG monitoring can be applied successfully in this cohort, within a specified time period, obtaining minimum artefact (defined as < 25% artefact). EEG recordings will not be used to guide clinical management during this feasibility study.

详细描述

See study protocol attached

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
0 Months 至 176 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children between 0 and 15 years and 11 months who present to Resuscitation Room, ED, CUH with a Glasgow Coma Scale (GCS) < 11 or, a reduction in baseline GCS in the case of children with significant neurodisability at baseline

排除标准

  • Polytrauma
  • Open head wounds
  • Unstable airway or requirement for bag and mask ventilation, where cap application would affect clinical management

结局指标

主要结局

The percentage of children who had EEG monitoring applied within twenty minutes and obtainment of an interpretable EEG recording with less than 25% artefact.

时间窗: Anticipated 12 month study period

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Deirdre Murray

Associate Professor and Consultant Paediatrician, Department of Paediatrics and Child Health and INFANT, UCC, Cork University Hospital

University College Cork

研究点 (1)

Loading locations...

相似试验