Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-02-19 @ 9:16 PM
Study NCT ID:
NCT03975751
Status:
COMPLETED
Last Update Posted:
2019-06-05
First Post:
2019-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Practice of Sedation and Analgesia in Patients With Severe Brain Injury in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D000377', 'term': 'Agnosia'}], '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'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 387}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-03', 'studyFirstSubmitDate': '2019-06-02', 'studyFirstSubmitQcDate': '2019-06-03', 'lastUpdatePostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance of sedation assessment', 'timeFrame': 'The previous 24 hours prior to the on-site investigation', 'description': 'The percentage of patients receiving sedation assessment'}, {'measure': 'Performance of pain assessment', 'timeFrame': 'The previous 24 hours prior to the on-site investigation', 'description': 'The percentage of patients receiving pain assessment'}], 'secondaryOutcomes': [{'measure': 'Use of sedatives', 'timeFrame': 'The previous 24 hours prior to the on-site investigation', 'description': 'The percentage of patients receiving sedatives'}, {'measure': 'Use of analgesics', 'timeFrame': 'The previous 24 hours prior to the on-site investigation', 'description': 'The percentage of patients receiving analgesics'}, {'measure': 'ICU mortality', 'timeFrame': 'Within 60 days after on-site investigation', 'description': 'The percentage of patients dead in the ICU'}, {'measure': 'Hospital mortality', 'timeFrame': 'Within 60 days after on-site investigation', 'description': 'The percentage of patients dead in the hospital'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['severe brain injuries', 'sedation and analgesia', 'intensive care unit', 'survey'], 'conditions': ['Intensive Care Unit']}, 'referencesModule': {'references': [{'pmid': '33627067', 'type': 'DERIVED', 'citation': "Chen K, Yang YL, Li HL, Xiao D, Wang Y, Zhang L, Zhou JX. A gap existed between physicians' perceptions and performance of pain, agitation-sedation and delirium assessments in Chinese intensive care units. BMC Anesthesiol. 2021 Feb 25;21(1):61. doi: 10.1186/s12871-021-01286-w."}]}, 'descriptionModule': {'briefSummary': 'Sedation and analgesia is necessary management for patients in the intensive care units. The high-level studies of sedation and analgesia in China are still deficient, especially in patients with brain injuries who even have been excluded from the relevant studies.', 'detailedDescription': 'Sedation and analgesia is necessary management for patients in the intensive care units. The high-level studies of sedation and analgesia in China are still deficient, especially in patients with brain injuries who even have been excluded from the relevant studies. In the present study, a multicenter, 1-day point cross-sectional study about the sedation and analgesia among patients in China, particularly brain-injured will be investigated. The objectives are to investigate sedation and analgesia among patients in China and to compare sedation and analgesia between brain injuries and other patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the patients at 9am on the on-site investigation day in the participating ICUs will be screened and enrolled according to the inclusion and exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult patients admitted to the participating ICUs on the investigation day\n\nExclusion Criteria:\n\n* Age under 18 years\n* Less than 24 hours of ICU stay before screening\n* Taking part in other studies'}, 'identificationModule': {'nctId': 'NCT03975751', 'briefTitle': 'Practice of Sedation and Analgesia in Patients With Severe Brain Injury in China', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'A Survey on the Practice of Sedation and Analgesia Among Patients With Severe Brain Injury in China: a Prospective Observational Study', 'orgStudyIdInfo': {'id': 'KY2017-062-02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'The Glasgow Coma Scale (GCS)', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['The Richmond Agitation-Sedation Scale (RASS)', 'The self-reported pain assessment'], 'description': 'Use the common GCS, RASS and self-reported pain assessment for evaluating consciousness, agitation/sedation and analgesia.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'ICU, Beijing Tiantan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Jian-Xin Zhou, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Beijing Tiantan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jian-Xin Zhou', 'investigatorAffiliation': 'Capital Medical University'}}}}