Parameters Analysis in Neurosurgical Critical Patients Through Big Data Acquisition (PANDA)

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

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.

Study Overview

• Status: Unknown
• Conditions: Intracranial Pressure; Neurosurgery; Information Management

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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Guoyi Gao, Dr.; Phone Number: +86-021-68383709; Email: guoyigao@gmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
      • Contact: Guoyi Gao, M.D.; Phone Number: +86-021-68383709; Email: guoyigao@gmail.com
      • Principal Investigator: Guoyi Gao, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with intracranial lesion

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: RenJi Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2017
• Primary Completion (ANTICIPATED): April 1, 2018
• Study Completion (ANTICIPATED): July 1, 2018

Study Registration Dates

• First Submitted: March 12, 2017
• First Submitted That Met QC Criteria: March 19, 2017
• First Posted (ACTUAL): March 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 15, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: Renjineuro-BDA(2017)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No