Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2026-01-05 @ 6:46 PM
Study NCT ID:
NCT00703495
Status:
COMPLETED
Last Update Posted:
2009-04-06
First Post:
2008-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Invasive and Non-Invasive Assessment of Cerebral Oxygenation in Patients With Severe Traumatic Brain Injury (TBI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2009-08-10', 'releaseDate': '2009-06-23'}], 'estimatedResultsFirstSubmitDate': '2009-06-23'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}], '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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-03', 'studyFirstSubmitDate': '2008-06-19', 'studyFirstSubmitQcDate': '2008-06-20', 'lastUpdatePostDateStruct': {'date': '2009-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correlation between rSO2 and PbtO2', 'timeFrame': 'four months'}], 'secondaryOutcomes': [{'measure': 'correlation between rSO2 and CPP', 'timeFrame': 'four months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['traumatic', 'brain injury', 'brain regional oxygen saturation (rSO2)', 'brain tissue oxygenation (PbtO2)', 'cerebral perfusion pressure (CPP)'], 'conditions': ['Brain Injuries']}, 'referencesModule': {'references': [{'pmid': '20502869', 'type': 'DERIVED', 'citation': 'Leal-Noval SR, Cayuela A, Arellano-Orden V, Marin-Caballos A, Padilla V, Ferrandiz-Millon C, Corcia Y, Garcia-Alfaro C, Amaya-Villar R, Murillo-Cabezas F. Invasive and noninvasive assessment of cerebral oxygenation in patients with severe traumatic brain injury. Intensive Care Med. 2010 Aug;36(8):1309-17. doi: 10.1007/s00134-010-1920-7. Epub 2010 May 26.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the relationship among regional transcranial oxygen saturation (rSO2), brain tissue oxygen pressure (PbtO2) and cerebral perfusion pressure (CPP) in patients with severe traumatic brain injury (TBI).', 'detailedDescription': 'Experience with rsO2 assessed by near infrared spectroscopy (NIRS) in patients with severe TBI is lacking. Reports about the usefulness of rSO2 are contradictory as regards its technical reliability and clinical value. Continuous time-domain analysis comparing rSO2, PbtO2 and CPP has never been carried out and the correlation among these variables remains largely unknown. A significant association between rSO2 and these clinically important variables would suggest that cerebral oximetry provides relevant data signifying that rSO2 might be a useful tool assessing cerebral oxygenation in selected patients with TBI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Stable patients with severe traumatic brain injury (Glasgow Coma Scale \\< 9) monitored through intracranial pressure (ICP) and brain tissue partial pressure of oxygen (PbtO2) probe, inserted for indications other than inclusion in this study', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Severe Traumatic Brain Injury (Glasgow Coma Scale \\< 9)\n* Having an intraparenchymal cerebral ICP/PbtO2 catheter previously inserted.\n* Expected length of ICU stay \\> 1 days\n\nExclusion Criteria:\n\n* Patient's relatives refusal to patient's inclusion in the study\n* Patients necessitating ongoing resuscitation\n* End-stage in which death is imminent\n* Deficient signal of rSO2 impeding its proper valuation"}, 'identificationModule': {'nctId': 'NCT00703495', 'briefTitle': 'Invasive and Non-Invasive Assessment of Cerebral Oxygenation in Patients With Severe Traumatic Brain Injury (TBI)', 'organization': {'class': 'OTHER', 'fullName': 'Hospitales Universitarios Virgen del Rocío'}, 'officialTitle': 'Validation of Non- Invasive Regional Transcranial Oxygen Saturation (rSO2) by Comparison With Invasive Brain Tissue Oxygenation (PbtO 2) Measurement in Patients With Severe Traumatic Brain Injury', 'orgStudyIdInfo': {'id': 'PI 06/2008'}}, 'armsInterventionsModule': {'interventions': [{'name': 'transcranial oxygen saturation measurement (INVOS Somanetics 5100C)', 'type': 'DEVICE', 'otherNames': ['INVOS Somanetics 5100C'], 'description': 'rSO2 measurement'}]}, 'contactsLocationsModule': {'locations': [{'zip': '41013', 'city': 'Seville', 'state': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario "Virgen del Rocío"', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'overallOfficials': [{'name': 'Santiago R Leal-Noval, M.D., PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario "Virgen del Rocío", Seville, Spain'}, {'name': 'Aurelio Cayuela, M.D., PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario "Virgen del Rocío", Seville, Spain'}, {'name': 'Victoria Arellano, M.D., PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario "Virgen del Rocío", Seville, Spain'}, {'name': 'Yael Corcia, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario "Virgen del Rocío", Seville, Spain'}, {'name': 'Vicente Padilla, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario "Virgen del Rocío", Seville, Spain'}, {'name': 'Claudio Garcia-Alfaro, M.D., PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario "Virgen del Rocío", Seville, Spain'}, {'name': 'Antonio Marín, M.D., PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario "Virgen del Rocío", Seville, Spain'}, {'name': 'Francisco Murillo, M.D., PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Universitario "Virgen del Rocío", Seville, Spain'}, {'name': 'Rosario Amaya, M.D., PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario "Virgen del Rocío", Seville, Spain'}, {'name': 'Maria Dolores Rincón, M.D., PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario "Virgen del Rocío", Seville, Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospitales Universitarios Virgen del Rocío', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Leal Noval, Santiago R.', 'oldOrganization': 'Hospitales Universitarios "Virgen del Rocio"'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2009-06-23', 'type': 'RELEASE'}, {'date': '2009-08-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Hospitales Universitarios "Virgen del Rocio" (Leal Noval, Santiago R.)'}}}}