Parameters Analysis in Neurosurgical Critical Patients Through Big Data Acquisition

Neurosurgery Clinical Trial

— PANDA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03087981
• Other study ID #: Renjineuro-BDA(2017)
• Status: Recruiting
• Phase: N/A
• First received: March 12, 2017
• Last updated: September 13, 2017
• Start date: October 2017
• Est. completion date: July 2018

Study information

• Verified date: March 2017
• Source: RenJi Hospital
• Contact: Guoyi Gao, Dr.
• Phone: +86-021-68383709
• Email: guoyigao[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Information Management
• Intracranial Pressure
• Neurosurgery

Locations

Country	Name	City	State
China	Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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

Outcome

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