A Multicenter Prospective Observational Study to Analyze Various ICP Derived Parameters and Clinical Status in Neurosurgical Critical Patients Through Big Data Acquisition
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Glasgow Outcome Scale(GOS)
研究概览
简要总结
The PANDA trial is a multicenter prospective observational study designed to analyze various ICP derived parameters and clinical status in neurosurgical critical patients through a new big data acquisition system.
详细描述
Nowadays, intracranial pressure (ICP) monitoring is widely used as a way to evaluate intracranial status in neurosurgery department especially in neurosurgical critical patients. Most of us focus only on the mean ICP value while ignoring other ICP derived parameters, such ICP waveform, AMP, RAP, PRx, IAAC and so on. However, it is reported that these parameters can reflect the status of intracerebral circulation, cerebrospinal compensatory reserve and brain compliance and can often be indicative of impending neurological deterioration and even outcome of patients. The PANDA trial is a multicenter prospective observational study designed to investigate the relationship between these ICP derived parameters and clinical status and to uncover the mechanism behind it. We will use a brand-new automatic big data collecting and storing system to continuously acquire patients' physiological information such as blood pressure, ICP, ETCO2,EEG etc. before analysis. Hopefully, this trial will reveal what is happening in the cranial cavity through the natural history of different kinds of intracranial lesion.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years old
- •Intracranial lesion underwent ICP sensor implantation
- •Informed consent obtained
排除标准
- •No consent
- •A life-threatening injury to an organ other than the brain
- •Known pregnancy
结局指标
主要结局
Glasgow Outcome Scale(GOS)
时间窗: within 3 months after enrollment
Glasgow Coma Scale(GCS)
时间窗: within 3 months after enrollment
Disability Rating Scale (DRS)
时间窗: within 3 months after enrollment
ICP-arterial blood pressure(ABP) wave amplitude correlation(IAAC)
时间窗: throughout ICP monitoring, average 7 days
Mean intracranial pressure(ICP) value
时间窗: throughout ICP monitoring, average 7 days
Correlation between pulse amplitude and mean intracranial pressure(RAP)
时间窗: throughout ICP monitoring, average 7 days
Pressure-reactivity index(PRx)
时间窗: throughout ICP monitoring, average 7 days
Pulse amplitude of ICP(AMP)
时间窗: throughout ICP monitoring, average 7 days
Cerebral perfusion pressure(CPP)
时间窗: throughout ICP monitoring, average 7 days
次要结局
未报告次要终点
