NCT04247321撤回不适用
Non-invasive Near-infrared Spectroscopy (NIRS) Versus Invasive Licox Intracranial Pressure Monitoring in Neurocritical Care
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 试验地点
- 2
- 主要终点
- Correlation between changes in Licox and NIRS oxygenation measurements
研究概览
简要总结
Researchers are trying to assess how accurately and safely NIRS non-invasive monitoring can detect changes in intracranial pressure to determine if this noninvasive device can be used instead of invasive monitoring with Licox in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Correlation between changes in Licox and NIRS oxygenation measurements
时间窗: 3 to 5 days of the monitoring duration
Licox measures oxygenation in terms of partial pressure (PtO2) and NIRS measures it in terms of saturation (rSO2). The changes in PtO2 versus the changes in rSO2 will be compared for equivalence.
次要结局
- Correlation between changes in pressure reactivity index and Licox versus NIRS(3 to 5 days of the monitoring duration)
研究者
Alejandro Rabinstein
Principal Investigator
Mayo Clinic
研究点 (2)
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