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Parameters Analysis in Neurosurgical Critical Patients Through Big Data Acquisition

NCT ID: NCT03087981

Last Updated: 2017-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-31

Study Completion Date

2018-07-31

Brief Summary

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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

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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.

Conditions

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Intracranial Pressure Neurosurgery Information Management

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guoyi Gao, Dr.

Role: CONTACT

[email protected]
+86-021-68383709

Facility Contacts

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Guoyi Gao, M.D.

Role: primary

[email protected]
+86-021-68383709

References

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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.

Reference Type BACKGROUND
PMID: 23389057 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22324419 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17613228 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15145991 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19963821 (View on PubMed)

Other Identifiers

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Renjineuro-BDA(2017)

Identifier Type: -

Identifier Source: org_study_id