Non-invasive Near-infrared Spectroscopy (NIRS) Versus Invasive Licox Intracranial Pressure Monitoring in Neurocritical Care
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 试验地点
- 1
- 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
- •Subjects with acute brain injury who are age ≥ 18
- •Glasgow coma scale score (GCS) ≤ 8
- •Neuroimaging concerning for ICP crises, or have active ICP treatment
- •Have Licox Brain Tissue Oxygen monitor placed as standard of care treatment
排除标准
- •CNS infection
- •Bleeding diathesis or thrombocytopenia < 50,000 platelets
- •Subjects with subdural hematomas who have had surgical decompression and bone flap removal
研究组 & 干预措施
Subjects with acute brain injury
Subjects requiring placement of a Licox Brain Tissue Oxygen device for their clinical care will also have Near-infrared spectroscopy (NIRS) monitoring system placed
干预措施: Near-infrared spectroscopy (NIRS) (Device)
Subjects with acute brain injury
Subjects requiring placement of a Licox Brain Tissue Oxygen device for their clinical care will also have Near-infrared spectroscopy (NIRS) monitoring system placed
干预措施: Licox® Brain Tissue Oxygen Monitoring System (Device)
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