Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-03-03 @ 12:24 PM
Study NCT ID:
NCT02742818
Status:
COMPLETED
Last Update Posted:
2019-12-30
First Post:
2016-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nwolosker@yahoo.com.br', 'phone': '+55 11 2151-5423', 'title': 'Dr. Nelson Wolosker', 'organization': 'Hospital Israelita Albert Einstein'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Upper Body Blanket', 'description': 'Patients undergoing EVAR and LEA will use this type of warming blanket.\n\n522 upper body blanket, Bair Hugger, 3M', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Underbody Blanket', 'description': 'Patients undergoing EVAR and LEA will use this type of warming blanket.\n\n635 full access underbody blanket, Bair Hugger, 3M', 'otherNumAtRisk': 25, 'otherNumAffected': 1, 'seriousNumAtRisk': 25, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaphylatic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Anaphylatic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Values of Body Temperature ( in Celsius Degree ) in Two Groups of Patients Undergoing EVAR and LEA That Will Use Two Different Types of Bair Hugger 3M Body Warming Blankets, Namely: 522 Upper Body Blanket and 635 Full Access Underbody Blanket.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Upper Body Blanket', 'description': 'Patients undergoing EVAR and LEA will use this type of warming blanket.\n\n522 upper body blanket, Bair Hugger, 3M'}, {'id': 'OG001', 'title': 'Underbody Blanket', 'description': 'Patients undergoing EVAR and LEA will use this type of warming blanket.\n\n635 full access underbody blanket, Bair Hugger, 3M'}], 'classes': [{'categories': [{'measurements': [{'value': '36.2', 'groupId': 'OG000', 'lowerLimit': '35.1', 'upperLimit': '37.3'}, {'value': '36.1', 'groupId': 'OG001', 'lowerLimit': '34.3', 'upperLimit': '37.1'}]}]}], 'analyses': [{'pValue': '0.190', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Generalized Estimation Equations (GEE)', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Model assuming Gaussian distribution and AR-1 correlation structure, considering repeated measures in time.', 'otherAnalysisDescription': 'Through inference, changes in body temperature and proportional occurrence of hypothermia during surgery were evaluated using general models of estimating equations (GEE, Liang e Zeger, 1986). Binominal and normal distributions were taken into account, respectively, and assumptions for errors normalities were verified using residual plot graphs and fitted values. The significance of other associated factors and probable outcomes were verified, including gender, age, surgery type and total surgery duration, in minutes. Since analyses were longitudinal, AR-1 working correlation matrix was created.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Across duration of surgery (up to 210 minutes)', 'description': 'After tracheal intubation, upper body or underbody blanket will be turned on at the highest temperature of the warming unit ( 43 celsius degree) and the body temperatures will be measured and registered with an esophageal thermometer every 15 minutes until tracheal extubation. Temperatures will be compared with the purposes of determining which one of the two models tested are more effective in keeping patient warm. Values of body temperature across duration of surgery will be compared by models of variance analysis with repeated measurements. Duration of surgery will be used as a control variable.', 'unitOfMeasure': 'Celsius degrees', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'In the Underbody blanket group 2 patients were excluded from analysis. One of the patients due to anaphylactic reaction and the other framed exclusion criteria (Surgery time lesser than 45 minutes)'}, {'type': 'SECONDARY', 'title': 'Age ( in Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Upper Body Blanket', 'description': 'Patients undergoing EVAR and LEA will use this type of warming blanket.\n\n522 upper body blanket, Bair Hugger, 3M'}, {'id': 'OG001', 'title': 'Underbody Blanket', 'description': 'Patients undergoing EVAR and LEA will use this type of warming blanket.\n\n635 full access underbody blanket, Bair Hugger, 3M'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '73'}, {'value': '71', 'groupId': 'OG001', 'lowerLimit': '60.5', 'upperLimit': '76.5'}]}]}], 'analyses': [{'pValue': '0.820', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'At time of surgery ( in minutes)', 'description': 'The investigators will observe the profile of the patients and the mean of age in two groups.', 'unitOfMeasure': 'years', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gender', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Underbody Blanket', 'description': 'Patients undergoing EVAR and LEA will use this type of warming blanket.\n\n635 full access underbody blanket, Bair Hugger, 3M'}, {'id': 'OG001', 'title': 'Upper Body Blanket', 'description': 'Patients undergoing EVAR and LEA will use this type of warming blanket.\n\n522 upper body blanket, Bair Hugger, 3M'}], 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.529', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At time of surgery ( in minutes)', 'description': 'The investigators will observe gender distribution in the two groups studied.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Type of Surgery ( LEA and EVAR )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Upper Body Blanket', 'description': 'Patients undergoing EVAR and LEA will use this type of warming blanket.\n\n522 upper body blanket, Bair Hugger, 3M'}, {'id': 'OG001', 'title': 'Underbody Blanket', 'description': 'Patients undergoing EVAR and LEA will use this type of warming blanket.\n\n635 full access underbody blanket, Bair Hugger, 3M'}], 'classes': [{'categories': [{'title': 'EVAR', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'LEA', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.999', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At time of surgery ( in minutes)', 'description': 'The investigators will observe the type of surgery distribution profile in the two groups studied.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Surgery ( in Minutes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Upper Body Blanket', 'description': 'Patients undergoing EVAR and LEA will use this type of warming blanket.\n\n522 upper body blanket, Bair Hugger, 3M'}, {'id': 'OG001', 'title': 'Underbody Blanket', 'description': 'Patients undergoing EVAR and LEA will use this type of warming blanket.\n\n635 full access underbody blanket, Bair Hugger, 3M'}], 'classes': [{'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000', 'lowerLimit': '150', 'upperLimit': '210'}, {'value': '210', 'groupId': 'OG001', 'lowerLimit': '135', 'upperLimit': '232.5'}]}]}], 'analyses': [{'pValue': '0.462', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Across duration of surgery ( in minutes)', 'description': 'The investigators will observe the duration of surgery (in minutes) in the two groups studied.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Models of generalized estimation equations will be used to evaluate the evolution of body temperature across duration of surgery (in minutes)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Upper Body Blanket', 'description': 'Patients undergoing EVAR and LEA will use this type of warming blanket.\n\n522 upper body blanket, Bair Hugger, 3M'}, {'id': 'FG001', 'title': 'Underbody Blanket', 'description': 'Patients undergoing EVAR and LEA will use this type of warming blanket.\n\n635 full access underbody blanket, Bair Hugger, 3M'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Underbody Blanket', 'description': 'Patients undergoing EVAR and LEA will use this type of warming blanket.\n\n635 full access underbody blanket, Bair Hugger, 3M'}, {'id': 'BG001', 'title': 'Upper Body Blanket', 'description': 'Patients undergoing EVAR and LEA will use this type of warming blanket.\n\n522 upper body blanket, Bair Hugger, 3M'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000', 'lowerLimit': '60.5', 'upperLimit': '76.5'}, {'value': '70', 'groupId': 'BG001', 'lowerLimit': '62', 'upperLimit': '73'}, {'value': '70.5', 'groupId': 'BG002', 'lowerLimit': '60.25', 'upperLimit': '74.75'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-20', 'studyFirstSubmitDate': '2016-03-30', 'resultsFirstSubmitDate': '2017-11-05', 'studyFirstSubmitQcDate': '2016-04-18', 'lastUpdatePostDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-22', 'studyFirstPostDateStruct': {'date': '2016-04-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Values of Body Temperature ( in Celsius Degree ) in Two Groups of Patients Undergoing EVAR and LEA That Will Use Two Different Types of Bair Hugger 3M Body Warming Blankets, Namely: 522 Upper Body Blanket and 635 Full Access Underbody Blanket.', 'timeFrame': 'Across duration of surgery (up to 210 minutes)', 'description': 'After tracheal intubation, upper body or underbody blanket will be turned on at the highest temperature of the warming unit ( 43 celsius degree) and the body temperatures will be measured and registered with an esophageal thermometer every 15 minutes until tracheal extubation. Temperatures will be compared with the purposes of determining which one of the two models tested are more effective in keeping patient warm. Values of body temperature across duration of surgery will be compared by models of variance analysis with repeated measurements. Duration of surgery will be used as a control variable.'}], 'secondaryOutcomes': [{'measure': 'Age ( in Years)', 'timeFrame': 'At time of surgery ( in minutes)', 'description': 'The investigators will observe the profile of the patients and the mean of age in two groups.'}, {'measure': 'Gender', 'timeFrame': 'At time of surgery ( in minutes)', 'description': 'The investigators will observe gender distribution in the two groups studied.'}, {'measure': 'Type of Surgery ( LEA and EVAR )', 'timeFrame': 'At time of surgery ( in minutes)', 'description': 'The investigators will observe the type of surgery distribution profile in the two groups studied.'}, {'measure': 'Duration of Surgery ( in Minutes)', 'timeFrame': 'Across duration of surgery ( in minutes)', 'description': 'The investigators will observe the duration of surgery (in minutes) in the two groups studied.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['forced-air warming', 'hypothermia', 'endovascular surgery', 'blanket'], 'conditions': ['Hypothermia']}, 'descriptionModule': {'briefSummary': 'Prospective randomized trial comparing effectiveness of two different forced-air warming blankets in patients undergoing lower extremity angioplasty (LEA) and endovascular abdominal aortic aneurysm repair (EVAR).', 'detailedDescription': 'Fifty patients undergoing LEA and EVAR will be randomized into two groups: Group upper body blanket and Group underbody blanket. All patients will receive general anesthesia and body temperature will be measured and registered by an esophageal thermometer with 15 minutes interval beginning immediately after tracheal intubation up to tracheal extubation. The warming unit used (Bair Hugger 750 warming unit, Arizant Healthcare) will be the same for both groups and the blankets tested will be: upper body blanket (Bair Hugger 522 upper body blanket, 3M) and underbody blanket (Bair Hugger 635 full acess underbody blanket, 3M). Surgical and anesthetic complications will be noted. Only surgeries with minimum 45 minutes duration will be accepted for the purposes of this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing LEA and EVAR\n* American Society of Anesthesiologists physical status (ASA) : 1-4\n\nExclusion Criteria:\n\n* Non-endovascular surgery\n* pregnant patients\n* patient refusal\n* less than 45 minutes duration of surgery'}, 'identificationModule': {'nctId': 'NCT02742818', 'briefTitle': 'Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Israelita Albert Einstein'}, 'officialTitle': 'Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models', 'orgStudyIdInfo': {'id': 'Forced-air warming in ES'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Upper body blanket, Bair Hugger', 'description': 'Patients undergoing EVAR and LEA will use this type of warming blanket.', 'interventionNames': ['Device: Upper body blanket, Bair Hugger']}, {'type': 'OTHER', 'label': 'Underbody blanket, Bair Hugger', 'description': 'Patients undergoing EVAR and LEA will use this type of warming blanket.', 'interventionNames': ['Device: Underbody blanket, Bair Hugger']}], 'interventions': [{'name': 'Upper body blanket, Bair Hugger', 'type': 'DEVICE', 'description': 'Upper body warming blanket will be used in patients undergoing LEA and EVAR.', 'armGroupLabels': ['Upper body blanket, Bair Hugger']}, {'name': 'Underbody blanket, Bair Hugger', 'type': 'DEVICE', 'description': 'Underbody warming blanket will be used in patients undergoing LEA and EVAR.', 'armGroupLabels': ['Underbody blanket, Bair Hugger']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nelson Wolosker', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, PHD', 'investigatorFullName': 'Nelson Wolosker', 'investigatorAffiliation': 'Hospital Israelita Albert Einstein'}}}}