Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT01126658
Status:
UNKNOWN
Last Update Posted:
2010-05-24
First Post:
2010-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation the Intracranial Volume Pressure Response in Increased Intracranial Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D019586', 'term': 'Intracranial Hypertension'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 41}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-05-20', 'studyFirstSubmitDate': '2010-05-18', 'studyFirstSubmitQcDate': '2010-05-18', 'lastUpdatePostDateStruct': {'date': '2010-05-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intracranial pressure', 'timeFrame': 'one minute.', 'description': 'The ICP values were obtained from the bedside ICU monitor. Once the ICP values exceed 20-25 mmHg, 1 ml of CSF was withdrawn from EVD and the corresponding change of ICP value was recorded. The withdrawn drainage of CSF continued until the final ICP value declined to 10 mmHg and the whole drainage procedure was completed within one minute.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pressure-volume curve', 'intracranial pressure', 'volume pressure response', 'pressure-volume relationship', 'mathematical model'], 'conditions': ['Brain Injury', 'Intracranial Hypertension']}, 'referencesModule': {'references': [{'pmid': '20714759', 'type': 'DERIVED', 'citation': 'Lai HY, Lee CY, Hsu HH, Lee ST. The intracranial volume pressure response in increased intracranial pressure patients: Part 1. Calculation of the volume pressure indicator. Acta Neurochir (Wien). 2012 Dec;154(12):2271-5; discussion 2275. doi: 10.1007/s00701-010-0765-8. Epub 2010 Aug 18.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to discover a mathematic equation to express the intracranial pressure-volume (P-V) curve and a single indicator to reflect the status of the curve.', 'detailedDescription': 'Monitoring of intracranial pressure (ICP) has been used in the management of patients with increased ICP, or in whom increased ICP was suspected. ICP depends on the relative constancy of total volume inside the skull, comprising cerebrospinal fluid (CSF), blood, and brain tissue. The changes of CSF volume affect the ventricular fluid pressure and defined it as volume pressure response (VPR). The shape or curve of the intracranial volume-pressure (V-P) relationship is well known in daily neurosurgical practice. If the P-V curve can be expressed by mathematic manner, then there should be an indicator to reflect the status of the curve. This study is conducted in order to understand the difference of each P-V curve in patients with increased intracranial pressure. The individual VPR values have been tested with three mathematical models (linear, parabolic and exponential regression equation).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'over 30 patients with severe brain injury and underwent bilateral external ventricular drainage in situ.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with severe brain damage\n* Underwent bilateral external ventricular drainage (EVD)\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01126658', 'briefTitle': 'Evaluation the Intracranial Volume Pressure Response in Increased Intracranial Pressure', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Evaluation of the Intracranial Volume Pressure Relationship in Increased Intracranial Pressure Patients by a Mathematic Manner', 'orgStudyIdInfo': {'id': 'CMRPG 371581'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All subjects act as their own contral', 'interventionNames': ['Other: drainage of cerebrospinal fluid (CSF)']}], 'interventions': [{'name': 'drainage of cerebrospinal fluid (CSF)', 'type': 'OTHER', 'description': 'Once the ICP exceed 20-25 mmHg, 1 ml of CSF was withdrawn from EVD and the corresponding change of ICP value was recorded. The withdrawn drainage of CSF continued until the final ICP value declined to 10 mmHg.', 'armGroupLabels': ['All subjects act as their own contral']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan District', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Shih-Tseng Lee, MD', 'role': 'CONTACT', 'email': 'yun0710@adm.cgmh.org.tw', 'phone': '886-3-3281200', 'phoneExt': '2119'}, {'name': 'Hung-Yi Lai, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Neurosurgery,Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'centralContacts': [{'name': 'Shih-Tseng Lee, MD', 'role': 'CONTACT', 'email': 'yun0710@adm.cgmh.org.tw', 'phone': '886-3-3281200', 'phoneExt': '2119'}], 'overallOfficials': [{'name': 'Shih-Tseng Lee, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Neurosurgery,Chang Gung Memorial Hospital'}, {'name': 'Hung-Yi Lai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurosurgery,Chang Gung Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Chang Gung Memorial Hospital', 'oldOrganization': 'Chang Gung Medical Research Council'}}}}