跳至主要内容
临床试验/NCT03087981
NCT03087981Unknown不适用

A Multicenter Prospective Observational Study to Analyze Various ICP Derived Parameters and Clinical Status in Neurosurgical Critical Patients Through Big Data Acquisition

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年10月最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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