Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT00711867
Status:
COMPLETED
Last Update Posted:
2009-12-15
First Post:
2008-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparison of Intraoperative Warming Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trentman.terrence@mayo.edu', 'phone': '480-301-8000', 'title': 'Terrence L Trentman MD', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'VH2 Temperature Management', 'description': 'Dynatherm vitalHeat2 (VH2) temperature management system.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bair Hugger Temperature Management', 'description': 'Arizant Bair Hugger temperature management system.', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sublingual Temperature.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VH2 Temperature Management', 'description': 'Dynatherm vitalHeat2 (VH2) temperature management system.'}, {'id': 'OG001', 'title': 'Bair Hugger Temperature Management', 'description': 'Arizant Bair Hugger temperature management system.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.38', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '36.73', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '-0.14', 'groupDescription': 'H0: Mu\\_VH - Mu\\_BH \\<= -0.5 C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The non-inferiority margin was defined as -0.5 C.'}], 'paramType': 'MEAN', 'timeFrame': 'Within 10 minutes of arrival in PACU', 'unitOfMeasure': 'C', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VH2 Temperature Management', 'description': 'Dynatherm vitalHeat2 (VH2) temperature management system.'}, {'id': 'FG001', 'title': 'Bair Hugger Temperature Management', 'description': 'Arizant Bair Hugger temperature management system.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '2 received additional warming. 3 missing primary measure.', 'groupId': 'FG000', 'numSubjects': '25'}, {'comment': '3 received additional warming. 1 missing primary measure.', 'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Patients were recruited sequentially and assigned to vitalHeat2 (VH2) or Bair Hugger temperature management at random in a 1:1 ratio.', 'preAssignmentDetails': '75 consented. 9 cancelled surgery or were rescheduled. 36 assigned to VH2 and 30 assigned to Bair Hugger. 6 excluded from VH2 group after randomization (2 vacuum not established, 2 research staff not available, 2 arterial line used). 5 excluded from Bair Hugger group after randomization (4 laryngeal mask airway used, 1 epidural anesthesia used).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'VH2 Temperature Management', 'description': 'Dynatherm vitalHeat2 (VH2) temperature management system.'}, {'id': 'BG001', 'title': 'Bair Hugger Temperature Management', 'description': 'Arizant Bair Hugger temperature management system.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.9', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '67.0', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '68.0', 'spread': '10.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-09', 'studyFirstSubmitDate': '2008-07-07', 'resultsFirstSubmitDate': '2009-10-28', 'studyFirstSubmitQcDate': '2008-07-08', 'lastUpdatePostDateStruct': {'date': '2009-12-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-10-28', 'studyFirstPostDateStruct': {'date': '2008-07-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sublingual Temperature.', 'timeFrame': 'Within 10 minutes of arrival in PACU'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Total Knee Arthroplasty']}, 'referencesModule': {'references': [{'pmid': '19779953', 'type': 'DERIVED', 'citation': 'Trentman TL, Weinmeister KP, Hentz JG, Laney MB, Simula DV. Randomized non-inferiority trial of the vitalHEAT temperature management system vs the Bair Hugger warmer during total knee arthroplasty. Can J Anaesth. 2009 Dec;56(12):914-20. doi: 10.1007/s12630-009-9199-2. Epub 2009 Sep 25.'}]}, 'descriptionModule': {'briefSummary': 'The sublingual (under the tongue) core temperature within 10 minutes of arrival in the post anesthesia care unit (PACU) for patients warmed with the Dynatherm vitalHeat2 (VH2) System under general anesthesia for total knee arthroplasty will be equivalent to that of patients warmed with the Arizant Bair Hugger System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Initial total knee arthroplasty.\n* Expected duration of surgery at least 2 hours.\n* General anesthesia.\n* American Society of Anesthesiologists (ASA) classification I-III.\n* Age \\>= 18 years.\n\nExclusion Criteria:\n\n* Skin abrasion at the device application site.\n* History of peripheral vascular disease.\n* History of allergic skin conditions of the upper extremities.\n* History of malignant hyperthermia.'}, 'identificationModule': {'nctId': 'NCT00711867', 'briefTitle': 'Comparison of Intraoperative Warming Devices', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Intraoperative Warming: Comparison of Performance of the Dynatherm Medical vitalHeat™ Temperature Management System (vH2) and the Arizant Bair Hugger System', 'orgStudyIdInfo': {'id': '07-003313'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VH2', 'description': 'Dynatherm vitalHeat2 (VH2) temperature management system.', 'interventionNames': ['Device: VH2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bair Hugger', 'description': 'Arizant Bair Hugger temperature management system.', 'interventionNames': ['Device: Bair Hugger']}], 'interventions': [{'name': 'VH2', 'type': 'DEVICE', 'description': 'Dynatherm vitalHeat2 (VH2) temperature management system.', 'armGroupLabels': ['VH2']}, {'name': 'Bair Hugger', 'type': 'DEVICE', 'description': 'Arizant Bair Hugger temperature management system.', 'armGroupLabels': ['Bair Hugger']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Kent Weinmeister, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dynatherm Medical Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Kent Weinmeister M.D.', 'oldOrganization': 'Mayo Clinic'}}}}