Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2026-02-10 @ 6:28 PM
Study NCT ID:
NCT02651103
Status:
COMPLETED
Last Update Posted:
2018-10-15
First Post:
2016-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Changes in Cerebral Oxygenation Based on Intraoperative Ventilation Strategy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'heather.dellinger@nationwidechildrens.org', 'phone': '6147222997', 'title': 'Clinical Research Coordinator', 'organization': "Nationwide Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'through study completion, an average of 2 years', 'description': 'All-Cause Mortality, Serious, or Other (non-serious) Adverse Events were monitored/assessed, but none observed', 'eventGroups': [{'id': 'EG000', 'title': 'Posterior Spinal Fusion', 'description': 'Patients undergoing spinal fusion surgery\n\nNIRS: Cerebral oxygenation monitor which is standard of care for this surgery.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Cerebral Oxygenation Values Throughout the Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterior Spinal Fusion', 'description': 'Patients undergoing spinal fusion surgery\n\nNIRS: Cerebral oxygenation monitor which is standard of care for this surgery.'}], 'classes': [{'title': 'Phase 1', 'categories': [{'measurements': [{'value': '83', 'spread': '8', 'groupId': 'OG000'}]}]}, {'title': 'Phase 2', 'categories': [{'measurements': [{'value': '79', 'spread': '8', 'groupId': 'OG000'}]}]}, {'title': 'Phase 3', 'categories': [{'measurements': [{'value': '81', 'spread': '9', 'groupId': 'OG000'}]}]}, {'title': 'Phase 4', 'categories': [{'measurements': [{'value': '83', 'spread': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'prior to induction of anesthesia in the awake patient and following four ventilation strategies (average time frame of 15 mins. to 5 hours)', 'description': 'Measured on the NIRS cerebral oxygenation monitor attached to the patient', 'unitOfMeasure': 'rSO2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Posterior Spinal Fusion', 'description': 'Patients undergoing spinal fusion surgery\n\nNIRS: Cerebral oxygenation monitor which is standard of care for this surgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Posterior Spinal Fusion', 'description': 'Patients undergoing spinal fusion surgery\n\nNIRS: Cerebral oxygenation monitor which is standard of care for this surgery.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-15', 'size': 335434, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-12-14T08:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-14', 'studyFirstSubmitDate': '2016-01-07', 'resultsFirstSubmitDate': '2017-09-28', 'studyFirstSubmitQcDate': '2016-01-07', 'lastUpdatePostDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-14', 'studyFirstPostDateStruct': {'date': '2016-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cerebral Oxygenation Values Throughout the Procedure', 'timeFrame': 'prior to induction of anesthesia in the awake patient and following four ventilation strategies (average time frame of 15 mins. to 5 hours)', 'description': 'Measured on the NIRS cerebral oxygenation monitor attached to the patient'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Posterior Spinal Fusion']}, 'descriptionModule': {'briefSummary': 'The proposed research aims to investigate how different ventilation strategies may affect cerebral tissue oxygenation in the pediatric population. It will contribute to the literature exploring the NIRS monitoring device which is becoming increasingly utilized in a variety of anesthetic and critical care settings. It may help to guide clinical practice regarding optimal ventilation strategies, and how ventilation may be altered to correct suboptimal cerebral tissue oxygenation.\n\nThis prospective study will include 50 patients undergoing posterior spinal fusion that requires placement of an arterial cannulation. There will be no change in the anesthetic or perioperative care of these patients. Tissue and cerebral oxygenation will be monitored using near infrared spectroscopy (NIRS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing posterior spinal fusion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient undergoing spinal surgery\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02651103', 'briefTitle': 'Changes in Cerebral Oxygenation Based on Intraoperative Ventilation Strategy', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Changes in Cerebral Oxygenation Based on Intraoperative Ventilation Strategy', 'orgStudyIdInfo': {'id': 'IRB15-01073'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Posterior spinal fusion', 'description': 'Patients undergoing spinal fusion surgery', 'interventionNames': ['Device: NIRS']}], 'interventions': [{'name': 'NIRS', 'type': 'DEVICE', 'description': 'Cerebral oxygenation monitor which is standard of care for this surgery.', 'armGroupLabels': ['Posterior spinal fusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Joseph D Tobias, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nationwide Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joseph D. Tobias', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chairman: Professor of Anesthesiology', 'investigatorFullName': 'Joseph D. Tobias', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}