Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:33 PM
Study NCT ID:
NCT03575169
Status:
COMPLETED
Last Update Posted:
2023-01-10
First Post:
2018-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-09', 'studyFirstSubmitDate': '2018-06-21', 'studyFirstSubmitQcDate': '2018-06-21', 'lastUpdatePostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean BIS', 'timeFrame': '24 hours', 'description': 'Mean BIS of patients sedated'}], 'secondaryOutcomes': [{'measure': 'Mean ICP', 'timeFrame': '24 hours', 'description': 'Mean ICP of sedated patient'}, {'measure': 'Incidence of osmotherapy use', 'timeFrame': '24 hours', 'description': 'Number of instances of osmotherapy use in sedated patients'}, {'measure': 'Vasopressor dose', 'timeFrame': '24 hours', 'description': 'Total vasopressor dose for sedated patients'}, {'measure': 'Sedative dose', 'timeFrame': '24 hours', 'description': 'Total sedative dose for sedated patients'}, {'measure': 'Length of ICU stay', 'timeFrame': 'Days to weeks', 'description': 'Number of days admitted to ICU'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bispectral index', 'Monitoring', 'Sedation', 'Traumatic Brain Injury'], 'conditions': ['Traumatic Brain Injury']}, 'referencesModule': {'references': [{'pmid': '38868457', 'type': 'DERIVED', 'citation': 'Kaye C, Rhodes J, Austin P, Casey M, Gould R, Sira J, Treweek S, MacLennan G. Assessment of depth of sedation using Bispectral Index monitoring in patients with severe traumatic brain injury in UK intensive care units. BJA Open. 2024 May 28;10:100287. doi: 10.1016/j.bjao.2024.100287. eCollection 2024 Jun.'}]}, 'descriptionModule': {'briefSummary': 'An observational study to assess the BIS reported level of sedation of patients with traumatic brain injury in the ICU.', 'detailedDescription': 'Patients admitted to Aberdeen ICU with severe traumatic brain injury will have a BIS electrode placed and observed for 24 hours. The study team will be blinded to the result, so not to influence treatment.\n\nAll clinical care is at the discretion of the clinical team.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with severe traumatic brain injury requiring sedation and mechanical ventilation who are admitted to Aberdeen ICU.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (over 18)\n* Diagnosis of traumatic brain injury\n* Expected to survive\n* Expected to require greater than 24 hours of sedation and mechanical ventilation\n\nExclusion Criteria:\n\n* Brain injury thought to be unsurvivable by ICU clinical team\n* Frontal decompressive craniectomy\n* Use of ketamine infusion at recruitment or planned use within 24 hours\n* Fractured frontal bone or severe overlying soft tissue injury\n* Simple extradural haemorrhage with no other obvious intracranial injury\n* Pregnant patient'}, 'identificationModule': {'nctId': 'NCT03575169', 'acronym': 'BIS-TBI', 'briefTitle': 'The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Aberdeen'}, 'officialTitle': 'The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury', 'orgStudyIdInfo': {'id': '1-063-18'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with TBI', 'description': 'Admitted to Aberdeen ICU with diagnosis of TBI and expected to require greater than 24 hours sedation.', 'interventionNames': ['Device: BIS Monitor']}], 'interventions': [{'name': 'BIS Monitor', 'type': 'DEVICE', 'description': 'Unilateral BIS electrode', 'armGroupLabels': ['Patients with TBI']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'AB25 2ZN', 'city': 'Aberdeen', 'country': 'United Kingdom', 'facility': 'Intensive Care Unit, Aberdeen Royal Infirmary', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'city': 'Dundee', 'country': 'United Kingdom', 'facility': 'NHS Tayside', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'NHS Lothian', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Leeds Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aberdeen', 'class': 'OTHER'}, 'collaborators': [{'name': 'NHS Grampian', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}