NCT01448681已完成不适用
A Continuous, Non-Invasive, Real-time Method for Estimating and Predicting Intracranial Hypertension
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Algorithm development
研究概览
简要总结
There is statistically significant correlation between invasive measures of intracranial pressure (ICP) and non-invasive, real-time, continuous physiologic waveform data algorithms to predict ICP. Furthermore, characteristics within this physiologic waveform data will allow modeling for trend prediction of derived ICP information. Specific aims:
- Develop models to estimate ICP and cerebral perfusion pressure (CPP) after traumatic brain injury in humans.
- Predict and anticipate changes in ICP for preemptive management purposes.
- Analyze characteristics of changes in ICP after treatment failure.
- Analyze data to predict/anticipate confounding physiologic factors that affect ICP and its treatment.
- Test the resulting models in real time.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with severe traumatic brain injury resulting in motor Glasgow Coma Score (GCS) score < 5
- •age 18-89 years
- •health care provider indicating the need for hyperosmolar therapy for elevated ICP
排除标准
- •pregnancy
- •incarceration
- •brain death (GCS 3 with fixed, dilated pupils)
- •life-threatening systemic injuries (Abbreviated Injury Scale (AIS) >4 in an organ system other than CNS)
结局指标
主要结局
Algorithm development
时间窗: 24 months
Developing algorithms relating data to intracranial pressure.
次要结局
未报告次要终点
研究者
研究点 (1)
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