Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-31 @ 4:11 AM
Study NCT ID:
NCT04736303
Status:
UNKNOWN
Last Update Posted:
2022-08-19
First Post:
2020-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of the Implementation of BIS on the Incidence of Postoperative Delirium
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-17', 'studyFirstSubmitDate': '2020-10-02', 'studyFirstSubmitQcDate': '2021-02-02', 'lastUpdatePostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of POD', 'timeFrame': '1st postoperative day', 'description': 'Assess the incidence of POD with CAM and Nu-DESC tools'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Delirium']}, 'descriptionModule': {'briefSummary': 'This study will investigate the incidence of postoperative POD in patients undergoing non cardiac surgery under general anesthesia with and without the implementation of the BIS monitoring.T', 'detailedDescription': 'This study will compare the incidence of POD after elective non cardiac surgery conducted under general anesthesia before and after the implementation of BIS monitoring in our University Hospital.\n\nThe POD will be evaluated with the CAM and Nu-DESC tools, which have been adapted for the greek population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. adult patients over 60 years of age\n2. an American Society of Anesthesiologists (ASA) physical status I to III\n3. undergoing elective non cardiac surgery under general anaesthesia\n4. native speakers of the Greek language\n5. eligible to leave the post-anaesthesia care unit\n6. an expected in-hospital stay at least 24 hours following surgery\n\nExclusion Criteria:\n\n1. refused to participate or sign the informed consent form\n2. surgery or anaesthesia within the last 30 day\n3. any prior or current history involving an affliction of the central nervous system\n4. severe hearing or visual impairment\n5. psychiatric disorders\n6. a score less than 5 according the Geriatric Depression Scale (GDS-15)\n7. a score less than 4 for females and less than 2 for males according to the Lawton-Brody Instrumental Activities of Daily Living Scale (I.A.D.L.)\n8. alcohol consumption less than 35 units/week\n9. drug dependence\n10. previous neuropsychological testing\n11. haemodynamical instability\n12. peri-procedural desaturation (one or more events of SpO2\\<80% for more than 2 minutes)'}, 'identificationModule': {'nctId': 'NCT04736303', 'briefTitle': 'The Impact of the Implementation of BIS on the Incidence of Postoperative Delirium', 'organization': {'class': 'OTHER', 'fullName': 'University of Thessaly'}, 'officialTitle': 'Assessing the Impact of the Implementation of BIS on the Incidence of Postoperative Delirium - A Monocentre Prospective Trial', 'orgStudyIdInfo': {'id': 'POD and BIS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'POD without BIS', 'description': 'Assessing the incidence of POD in patients under general anethesia for elective non cardiac surgery, with CAM and Nu-DESC tools.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'POD with BIS', 'description': 'Assessing the incidence of POD in patients under general anethesia for elective non cardiac surgery with the implementation of BIS monitoring, with CAM and Nu-DESC tools.', 'interventionNames': ['Device: BIS']}], 'interventions': [{'name': 'BIS', 'type': 'DEVICE', 'description': 'The implementation of BIS monitoring', 'armGroupLabels': ['POD with BIS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41110', 'city': 'Larissa', 'state': 'Thessaly', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Eleni Arnaoutoglou, MD, PhD', 'role': 'CONTACT', 'email': 'earnaout@gmail.com', 'phone': '2413501370'}, {'name': 'Maria Ntalouka, MD', 'role': 'CONTACT', 'email': 'maria.ntalouka@icloud.com', 'phone': '+306973688099'}, {'name': 'Maria Ntalouka, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Eleni Arnaoutoglou, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Metaxia Bareka, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Konstantinos Stamoulis, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eleonora Stertsou, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Georgia Micha, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Univeristy of Thessaly', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}], 'centralContacts': [{'name': 'Eleni Arnaoutoglou, MD, PhD', 'role': 'CONTACT', 'email': 'earnaout@gmail.com', 'phone': '+306974301352'}, {'name': 'Maria Ntalouka, MD, PhD', 'role': 'CONTACT', 'email': 'maria.ntalouka@icloud.com', 'phone': '+306973688099'}], 'overallOfficials': [{'name': 'Eleni Arnaoutoglou, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Thessaly'}, {'name': 'Maria Ntalouka, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Larissa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Thessaly', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology', 'investigatorFullName': 'Elena Arnaoutoglou', 'investigatorAffiliation': 'University of Thessaly'}}}}