Clinical trial NCT03087981: Parameters Analysis in Neurosurgical Critical Patients Through Big Data Acquisition
Official title: A Multicenter Prospective Observational Study to Analyze Various ICP Derived Parameters and Clinical Status in Neurosurgical Critical Patients Through Big Data Acquisition
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Pressure
Neurosurgery
Information Management
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2017-03-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with intracranial lesion

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.

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

Primary outcomes:
measure: Glasgow Outcome Scale(GOS)
timeFrame: within 3 months after enrollment
measure: Glasgow Coma Scale(GCS)
timeFrame: within 3 months after enrollment
measure: Disability Rating Scale (DRS)
timeFrame: within 3 months after enrollment
measure: Mean intracranial pressure(ICP) value
timeFrame: throughout ICP monitoring, average 7 days
measure: Correlation between pulse amplitude and mean intracranial pressure(RAP)
timeFrame: throughout ICP monitoring, average 7 days
measure: Pressure-reactivity index(PRx)
timeFrame: throughout ICP monitoring, average 7 days
measure: Pulse amplitude of ICP(AMP)
timeFrame: throughout ICP monitoring, average 7 days
measure: ICP-arterial blood pressure(ABP) wave amplitude correlation(IAAC)
timeFrame: throughout ICP monitoring, average 7 days
measure: Cerebral perfusion pressure(CPP)
timeFrame: throughout ICP monitoring, average 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
References:
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.
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.
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. doi: 10.3171/foc.2007.22.5.11.
citation: Czosnyka M, Pickard JD. Monitoring and interpretation of intracranial pressure. J Neurol Neurosurg Psychiatry. 2004 Jun;75(6):813-21. doi: 10.1136/jnnp.2003.033126.
citation: 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.