PANDA: Parameters Analysis in Neurosurgical Critical Patients Through Big Data Acquisition
Study Details
Study Description
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.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18-65 years old
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Intracranial lesion underwent ICP sensor implantation
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Informed consent obtained
Exclusion Criteria:
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No consent
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A life-threatening injury to an organ other than the brain
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Known pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | Shanghai | China | 200127 |
Sponsors and Collaborators
- RenJi Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Czosnyka M, Pickard JD. Monitoring and interpretation of intracranial pressure. J Neurol Neurosurg Psychiatry. 2004 Jun;75(6):813-21. Review.
- Czosnyka M, Smielewski P, Timofeev I, Lavinio A, Guazzo E, Hutchinson P, Pickard JD. Intracranial pressure: more than a number. Neurosurg Focus. 2007 May 15;22(5):E10.
- Di Ieva A, Schmitz EM, Cusimano MD. Analysis of intracranial pressure: past, present, and future. Neuroscientist. 2013 Dec;19(6):592-603. doi: 10.1177/1073858412474845. Epub 2013 Feb 6. Review.
- Eide PK, Sorteberg A, Bentsen G, Marthinsen PB, Stubhaug A, Sorteberg W. Pressure-derived versus pressure wave amplitude-derived indices of cerebrovascular pressure reactivity in relation to early clinical state and 12-month outcome following aneurysmal subarachnoid hemorrhage. J Neurosurg. 2012 May;116(5):961-71. doi: 10.3171/2012.1.JNS111313. Epub 2012 Feb 10.
- Hamilton R, Xu P, Asgari S, Kasprowicz M, Vespa P, Bergsneider M, Hu X. Forecasting intracranial pressure elevation using pulse waveform morphology. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:4331-4. doi: 10.1109/IEMBS.2009.5332749.
- Renjineuro-BDA(2017)