Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-02-21 @ 1:34 AM
Study NCT ID:
NCT00538369
Status:
TERMINATED
Last Update Posted:
2015-10-14
First Post:
2007-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combining Observational and Physiologic Sedation Assessment Tools
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056805', 'term': 'Consciousness Monitors'}], 'ancestors': [{'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'whyStopped': 'Lack of equipoise', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-11', 'studyFirstSubmitDate': '2007-10-01', 'studyFirstSubmitQcDate': '2007-10-01', 'lastUpdatePostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'How much sedative was infused', 'timeFrame': 'length of stay'}], 'secondaryOutcomes': [{'measure': 'How quickly the subject recovered from sedation', 'timeFrame': 'once'}, {'measure': 'The number of undersedation events', 'timeFrame': 'length of stay in ICU'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nursing', 'critical care', 'sedation assessment', 'Bispectral index'], 'conditions': ['Brain Injury']}, 'referencesModule': {'references': [{'pmid': '4835444', 'type': 'BACKGROUND', 'citation': 'Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.'}]}, 'descriptionModule': {'briefSummary': "When a physiologic tool to measure the patient's hypnotic state is added to current practice tools is there a decrease in the amount of drug the patient receives.", 'detailedDescription': 'The purposes of this study were to examine the effect of combining a physiologic measure of consciousness (BIS) with observational assessment of sedation (Ramsay) on infused sedation drug volumes, undersedation events, and the recovery time to arouse from sedation, in a group of neurocritically ill patients. During a 12-hour data collection period, patients received sedation assessment and management with either the current standard of care (sedation assessment with the Ramsay scale), or the standard of care plus the addition of physiologic data from BIS monitoring. Planned research questions explored how BIS monitoring impacts short-term sedation-related outcomes.\n\nResearch Questions\n\n* Is there less sedation drug use for patients when nurses monitor sedation with BIS augmentation of Ramsay than when nurses monitor patients with Ramsay alone?\n* Is sedation assessment augmented by BIS use associated with a decreased time to wake-up (recovery time) when nurses are instructed to interrupt sedation and obtain a neurologic examination, compared to use of Ramsay alone?\n* Are there differences in the number of events associated with undersedation (e.g., self-extubation) for patients assigned to BIS augmentation compared to patients assigned to Ramsay alone?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult\n* admitted with a neurological or neurosurgical diagnosis\n* intubated and on mechanical ventilatory support\n* receiving continuous sedation with propofol\n* Glasgow Coma Score \\<12\n\nExclusion Criteria:\n\n* bifrontal brain injury\n* status epilepticus\n* barbiturate coma therapy\n* continuous benzodiazepine administration'}, 'identificationModule': {'nctId': 'NCT00538369', 'acronym': 'COST', 'briefTitle': 'Combining Observational and Physiologic Sedation Assessment Tools', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Combining Observational and Physiologic Sedation Assessment Tools', 'orgStudyIdInfo': {'id': 'Pro00008519'}, 'secondaryIdInfos': [{'id': '8771-06 - 8RO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard-of-care', 'description': 'The standard-of-care group will receive sedation assessment and monitoring with the Ramsay scale, which is the accepted tool at this university', 'interventionNames': ['Other: Ramsay Scale']}, {'type': 'EXPERIMENTAL', 'label': 'standard + BIS', 'description': 'Subjects in the standard-of-care + BIS group will receive sedation assessment and monitoring using the Ramsay scale and values from the bispectral index (BIS) monitor.', 'interventionNames': ['Other: Ramsay Scale', 'Device: Bispectral index monitor']}], 'interventions': [{'name': 'Ramsay Scale', 'type': 'OTHER', 'otherNames': ['Ramsay sedation scale'], 'description': 'While receiving sedation, subjects will be monitored with the Ramsay scale', 'armGroupLabels': ['standard + BIS', 'standard-of-care']}, {'name': 'Bispectral index monitor', 'type': 'DEVICE', 'otherNames': ['BIS'], 'description': 'While receiving sedation, subjects will receive BIS monitoring', 'armGroupLabels': ['standard + BIS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'DaiWai M Olson, PhD RN CCRN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Suzanne M Thoyre, PhD RN', 'role': 'STUDY_CHAIR', 'affiliation': 'University of North Carolina, Chapel Hill'}, {'name': 'Carmelo Graffagnino, MD FRCPC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of North Carolina', 'class': 'OTHER'}, {'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}