Non-invasive Epicutaneous Transfontanel Intracranial Pressure Monitoring in Children Under the Age of One: a Novel Technique
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 主要终点
- Comparison of ICP values (mmHg), intracranial pressure obtained invasive and noninvasive in mmHg will be compared. Either there is a significant difference or not. The data will be collected hourly. Device: Spiegelberg ICP Probe.
研究概览
简要总结
Investigators compare the ICP of two standard Spiegelberg ICP-probes in children, which underwent an operation due to craniosynostosis.
详细描述
The investigators compare the ICP of two standard Spiegelberg ICP-probes in children, which underwent an operation and Implantation of an external ventricle drain or a subdural ICP Monitoring devise. The second ICP probe is fixed epicutaneously on the skin over the frontal fontanel. The hourly measured ICPs within 24 hours postoperatively were compared with the Bland-Altman two methods analysis.
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 Day 至 15 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child with open fontanel Need of ICP monitoring
排除标准
- •closed fontanel No Need of ICP monitoring
结局指标
主要结局
Comparison of ICP values (mmHg), intracranial pressure obtained invasive and noninvasive in mmHg will be compared. Either there is a significant difference or not. The data will be collected hourly. Device: Spiegelberg ICP Probe.
时间窗: 24 hours
ICP values in mmHg will be collected in both arms
次要结局
未报告次要终点
研究者
Bedjan Behmanesh
MD
University Clinic Frankfurt