Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-04-21 @ 9:13 AM
Study NCT ID:
NCT02674334
Status:
COMPLETED
Last Update Posted:
2017-09-11
First Post:
2015-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prospective Evaluation of Cognitive Outcomes After Anesthesia on Patients in the Beach Chair Position
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019265', 'term': 'Spectroscopy, Near-Infrared'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gbal@hsc.wvu.edu', 'phone': '304-293-1310', 'title': 'Dr. George K Bal', 'organization': 'West Virginia University Department of Orthopaedics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'It is difficult to generalize the results of the study, few CDEs, to similar populations. Intubation may be related to the occurrence of CDEs or may have been related to patient co-morbidities and not the actual intubation.'}}, 'adverseEventsModule': {'timeFrame': '1 day', 'description': 'Shoulder surgeries done as same-day surgery.', 'eventGroups': [{'id': 'EG000', 'title': 'NIRS Monitored Not Treated', 'description': 'Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists were blinded to the NIRS data and treated participants based on standard of care treatment.', 'otherNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'NIRS Monitored and Treated', 'description': 'Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists treated participants based on the NIRS monitoring in addition to standard of care.', 'otherNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With 20+% Cerebral Desaturation Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NIRS Monitored Not Treated', 'description': 'Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists were blinded to the NIRS monitoring and treated participants per standard of care based on MAP.'}, {'id': 'OG001', 'title': 'NIRS Monitored and Treated', 'description': 'Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists treated participants based on NIRS monitoring results in addition to standard of care treatment based on MAP.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'one day', 'description': 'Cerebral desaturation event defined as a 20% or greater decrease from baseline Mean Arterial Pressure, while undergoing elective ambulatory surgery in the beach chair position', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants undergoing elective shoulder surgery in the beach chair position at West Virginia University Medicine Hospital.'}, {'type': 'SECONDARY', 'title': 'Change in Mini Mental State Exam (MMSE) > 2 or a Score of 23 up to Two Weeks After Surgery Minus Baseline Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NIRS Monitored Not Treated', 'description': 'Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists were blinded to the NIRS monitoring and treated participants per standard of care based on MAP.'}, {'id': 'OG001', 'title': 'NIRS Monitored and Treated', 'description': 'Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists treated participants based on NIRS monitoring results in addition to standard of care treatment based on MAP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.33', 'spread': '.82', 'groupId': 'OG000'}, {'value': '-.17', 'spread': '.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.165', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '-.49', 'ciUpperLimit': '2.82', 'pValueComment': 'P-values were not adjusted for multiple inferences', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.83', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Continuous responses were tested using RCB ANOVA.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and up to two weeks', 'description': 'Change in total score of the MMSE measurement taken at baseline before surgery compared to the follow up measurement taken up to two weeks after surgery. Total range is zero to 30 with higher values indicating a better outcome. Indicator of cognitive decline measured by a change in Mini Mental State Exam (MMSE) \\> 2 or a score of 23 for two time points; up to two weeks after surgery minus the baseline value.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'participants', 'denomUnitsSelected': 'participants', 'populationDescription': 'Participants who underwent elective shoulder surgery in the beach chair position at West Virginia University Medicine Hospital.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NIRS Monitored Not Treated', 'description': 'Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists were blinded to the NIRS data and treated participants based on standard of care treatment.'}, {'id': 'FG001', 'title': 'NIRS Monitored and Treated', 'description': 'Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists treated participants based on the NIRS monitoring in addition to standard of care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'participant difficulty breathing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NIRS not recording', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were informed of the study in the Orthopaedic clinic at the visit prior to surgery. The consent form and pre- and post-testing using the Mini Mental State Examination (MMSE) was reviewed. Following consent, the baseline MMSE was administered. A score below 24 disqualified participants. Recruitment began October 2012 and ended May 2013.', 'preAssignmentDetails': 'Excluded reasons: anesthesiologist availability; surgery started early; illiteracy; less than 24 on the pre-operative MMSE; supine and BCP; no surgery; surgery delayed; operating suite could not accommodate NIRS monitor; data not recorded; previous difficult intubation; surgeon in two operating suites simultaneously; not needed, quota met.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'NIRS Monitored Not Treated', 'description': 'Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists were blinded to NIRS data and treated participants per standard of care.'}, {'id': 'BG001', 'title': 'NIRS Monitored and Treated', 'description': 'Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists treated participants based NIRS monitoring and per standard of care.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '>=18 years', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': '\\>=18 years', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-09', 'studyFirstSubmitDate': '2015-12-10', 'resultsFirstSubmitDate': '2016-11-09', 'studyFirstSubmitQcDate': '2016-02-03', 'lastUpdatePostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-09', 'studyFirstPostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With 20+% Cerebral Desaturation Events', 'timeFrame': 'one day', 'description': 'Cerebral desaturation event defined as a 20% or greater decrease from baseline Mean Arterial Pressure, while undergoing elective ambulatory surgery in the beach chair position'}], 'secondaryOutcomes': [{'measure': 'Change in Mini Mental State Exam (MMSE) > 2 or a Score of 23 up to Two Weeks After Surgery Minus Baseline Value', 'timeFrame': 'baseline and up to two weeks', 'description': 'Change in total score of the MMSE measurement taken at baseline before surgery compared to the follow up measurement taken up to two weeks after surgery. Total range is zero to 30 with higher values indicating a better outcome. Indicator of cognitive decline measured by a change in Mini Mental State Exam (MMSE) \\> 2 or a score of 23 for two time points; up to two weeks after surgery minus the baseline value.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['orthopedic procedures'], 'conditions': ['Injury as a Result of Positioning']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to use Near Infrared Spectroscopy (NIRS) monitoring on participants undergoing shoulder surgery in the beach chair position (BCP) to determine cerebral desaturation events (CDE) and to further determine cognitive changes pre and post surgery using the Mini Mental State Exam.', 'detailedDescription': 'In this prospective, randomized, controlled study, investigators used a standardized anesthesia protocol to maintain the Mean Arterial Pressure (MAP) during surgeries done in the Beach Chair Position (BCP). Investigators hypothesized that, if the MAP was maintained, Near Infrared Spectroscopy (NIRS) monitoring would not change intra-operative anesthesia management and would not affect the post-operative cognitive outcomes of participants undergoing surgery in the beach chair position. Investigators secondarily wanted to document the actual incidence of cerebral desaturation events (CDEs) recorded by NIRS occurring in participants placed in the BCP if the MAP was strictly maintained.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 18 years of age\n* elective shoulder surgery in the beach chair position\n\nExclusion Criteria:\n\n* less than 18 years of age\n* preoperative score of 23 or less on the pre-operative Mini Mental State Exam\n* traumatic brain injury\n* transient ischemic attack\n* cerebrovascular incident\n* any apparent clinical neurologic dysfunction\n* carotid artery stenosis\n* known vascular malformation in head\n* inability to have blood pressure measured in the opposite extremity\n* malignant hyperthermia'}, 'identificationModule': {'nctId': 'NCT02674334', 'acronym': 'BCP', 'briefTitle': 'Prospective Evaluation of Cognitive Outcomes After Anesthesia on Patients in the Beach Chair Position', 'organization': {'class': 'OTHER', 'fullName': 'West Virginia University'}, 'officialTitle': 'Prospective Evaluation of Cognitive Outcomes After Anesthesia on Patients in the Beach Chair Position', 'orgStudyIdInfo': {'id': '1409418786'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NIRS Monitored Not Treated', 'description': 'Anesthesiologist blinded to Near Infrared Spectroscopy (NIRS)', 'interventionNames': ['Device: NIRS monitored not treated']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NIRS Monitored and Treated', 'description': 'Anesthesiologist treats based on Near Infrared Spectroscopy (NIRS)', 'interventionNames': ['Device: NIRS']}], 'interventions': [{'name': 'NIRS', 'type': 'DEVICE', 'otherNames': ['Near infrared spectroscopy'], 'description': 'Near infrared spectroscopy (NIRS) monitor allows anesthesiologist to treat cerebral desaturations according to NIRS results while maintaining Mean Arterial Pressure (MAP) at least 60mmHG or at least 80% of baseline', 'armGroupLabels': ['NIRS Monitored and Treated']}, {'name': 'NIRS monitored not treated', 'type': 'DEVICE', 'otherNames': ['Near infrared spectroscopy'], 'description': 'Near infrared spectroscopy (NIRS) monitored but anesthesiologist blinded to NIRS information and treatment is standard of care.', 'armGroupLabels': ['NIRS Monitored Not Treated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26506-9196', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'George K Bal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West Virginia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only group data will be available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West Virginia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'George K Bal', 'investigatorAffiliation': 'West Virginia University'}}}}