Parameters Analysis in Neurosurgical Critical Patients Through Big Data Acquisition

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Intracranial Pressure, Neurosurgery, Information Management

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-65 years old Intracranial lesion underwent ICP sensor implantation Informed consent obtained Exclusion Criteria: No consent A life-threatening injury to an organ other than the brain Known pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow Outcome Scale(GOS) |  | within 3 months after enrollment | 
| Glasgow Coma Scale(GCS) |  | within 3 months after enrollment | 
| Disability Rating Scale (DRS) |  | within 3 months after enrollment | 
| Mean intracranial pressure(ICP) value |  | throughout ICP monitoring, average 7 days | 
| Correlation between pulse amplitude and mean intracranial pressure(RAP) |  | throughout ICP monitoring, average 7 days | 
| Pressure-reactivity index(PRx) |  | throughout ICP monitoring, average 7 days | 
| Pulse amplitude of ICP(AMP) |  | throughout ICP monitoring, average 7 days | 
| ICP-arterial blood pressure(ABP) wave amplitude correlation(IAAC) |  | throughout ICP monitoring, average 7 days | 
| Cerebral perfusion pressure(CPP) |  | throughout ICP monitoring, average 7 days |