Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT05198635
Status:
RECRUITING
Last Update Posted:
2025-02-13
First Post:
2022-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Association Between Local Cerebral Oxygenation Monitoring and Postoperative Delirium in Carotid Endarterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2022-01-04', 'studyFirstSubmitQcDate': '2022-01-15', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative delirium', 'timeFrame': 'With postoperative 5 day', 'description': 'Postoperative delirium is assessed by the Confusion assessment method for intensive care unit (CAM-ICU) or the 3-minute diagnostic interview for CAM (3D-CAM) when the patient is in intensive care unit or general ward, respectively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Oxygen Saturation', 'Postoperative Delirium', 'Carotid Endarterectomy']}, 'descriptionModule': {'briefSummary': "Postoperative delirium (POD) is a common perioperative complication, which can lead to adverse outcomes. Patients undergoing carotid endarterectomy (CEA) were elderly, complicated with vascular risk factors, cognitive dysfunction, some also had a history of stroke, and the circulation fluctuated greatly during the operation, often resulting in hypoperfusion of cerebral tissue and hypoxia. Therefore, they're the high-risk group of POD. Near-infrared Spectroscopy (NIRS) can continuously and noninvasively monitor local cerebral oxygen saturation (SctO2) to identify the mismatch of oxygen supply and demand in brain tissue. However, for CEA patients, the association between intraoperative SctO2 changes and POD remains unclear. This study intends to explore the association between them and determine the SctO2 threshold for predicting POD. We will monitor SctO2 intraoperatively, follow up and collect data postoperatively."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Scheduled carotid endarterectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nScheduled carotid endarterectomy; Signed informed consent.\n\nExclusion Criteria:\n\nSevere cognitive impairment(Mini-Mental State Examination, MMSE\\<18); History of psychotropic drugs; Previous intracranial surgery history; Poor hearing or vision; Language barriers'}, 'identificationModule': {'nctId': 'NCT05198635', 'briefTitle': 'Association Between Local Cerebral Oxygenation Monitoring and Postoperative Delirium in Carotid Endarterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Association Between Local Cerebral Oxygen Saturation Monitoring and Postoperative Delirium in Carotid Endarterectomy：A Prospective Cohort Study', 'orgStudyIdInfo': {'id': '20220105'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'interventionNames': ['Device: local cerebral oxygen saturation']}, {'label': 'Group 2', 'interventionNames': ['Device: local cerebral oxygen saturation']}], 'interventions': [{'name': 'local cerebral oxygen saturation', 'type': 'DEVICE', 'description': 'minimum SctO2, SctO2 drop/rise defined by different thresholds, and area under/above the threshold', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100160', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuming Peng', 'role': 'CONTACT', 'email': 'florapym766@163.com', 'phone': '8610-59976658'}], 'facility': 'Beijing Tian Tan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yuming MD Peng, Ph.D', 'role': 'CONTACT', 'email': 'florapym766@163.com', 'phone': '8610-59976658'}], 'overallOfficials': [{'name': 'Yuming MD Peng, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tian Tan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Yuming Peng', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}