Neurosurgery Clinical Trial
— PANDAOfficial title:
A Multicenter Prospective Observational Study to Analyze Various ICP Derived Parameters and Clinical Status in Neurosurgical Critical Patients Through Big Data Acquisition
Verified date | March 2017 |
Source | RenJi Hospital |
Contact | Guoyi Gao, Dr. |
Phone | +86-021-68383709 |
guoyigao[@]gmail.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | July 2018 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
RenJi Hospital |
China,
Czosnyka M, Pickard JD. Monitoring and interpretation of intracranial pressure. J Neurol Neurosurg Psychiatry. 2004 Jun;75(6):813-21. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Hamilton R, Xu P, Asgari S, Kasprowicz M, Vespa P, Bergsneider M, Hu X. Forecasting intracranial pressure elevation using pulse waveform morphology. Conf Proc IEEE Eng Med Biol Soc. 2009;2009:4331-4. doi: 10.1109/IEMBS.2009.5332749. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glasgow Outcome Scale(GOS) | within 3 months after enrollment | ||
Primary | Glasgow Coma Scale(GCS) | within 3 months after enrollment | ||
Primary | Disability Rating Scale (DRS) | within 3 months after enrollment | ||
Primary | Mean intracranial pressure(ICP) value | throughout ICP monitoring, average 7 days | ||
Primary | Correlation between pulse amplitude and mean intracranial pressure(RAP) | throughout ICP monitoring, average 7 days | ||
Primary | Pressure-reactivity index(PRx) | throughout ICP monitoring, average 7 days | ||
Primary | Pulse amplitude of ICP(AMP) | throughout ICP monitoring, average 7 days | ||
Primary | ICP-arterial blood pressure(ABP) wave amplitude correlation(IAAC) | throughout ICP monitoring, average 7 days | ||
Primary | Cerebral perfusion pressure(CPP) | throughout ICP monitoring, average 7 days |
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