Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-03-07 @ 10:18 PM
Study NCT ID:
NCT01670760
Status:
COMPLETED
Last Update Posted:
2020-09-22
First Post:
2012-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Zero Heat Flux Thermometry System Comparison Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'twhite3@mmm.com', 'phone': '651-733-0228', 'title': 'Terri White', 'organization': '3M'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'For the duration of the surgery from the time of incision to the time of closure. The average duration of surgery was 57 minutes.', 'eventGroups': [{'id': 'EG000', 'title': 'Zero-Heat-Flux', 'description': "This is a single arm study. All patients will have deep tissue temperature monitored from the nasopharyngeal and lateral forehead sites simultaneously.\n\nZero-heat-flux thermometry: The zero-heat-flux thermometer will be placed on the subject's lateral forehead for the duration of the surgery to measure deep tissue temperature.", 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 11, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Redness at attachment site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Body Temperature Difference in Degrees Celsius', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Observation', 'counts': [{'value': '247', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zero-Heat-Flux', 'description': "This is a single arm study. All patients will have deep tissue temperature monitored from the nasopharyngeal and lateral forehead sites simultaneously.\n\nZero-heat-flux thermometry: The zero-heat-flux thermometer will be placed on the subject's lateral forehead for the duration of the surgery to measure deep tissue temperature."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.027', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.69', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.69', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Every 5 to 10 minutes, or as clinically indicated, for the duration of the surgery from the time of incision to the time of closure. The average duration of surgery was 57 minutes.', 'description': 'Body temperature difference as defined by Agreement (bias - Zero heat flux thermometry minus nasopharyngeal) between simultaneously-acquired nasopharyngeal and forehead deep tissue temperatures as assessed by Bland and Altman repeated measures technique.', 'unitOfMeasure': 'Degrees Celsius', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Observation', 'denomUnitsSelected': 'Observation'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zero-Heat-Flux', 'description': "This is a single arm study. All patients will have deep tissue temperature monitored from the nasopharyngeal and lateral forehead sites simultaneously.\n\nZero-heat-flux thermometry: The zero-heat-flux thermometer will be placed on the subject's lateral forehead for the duration of the surgery to measure deep tissue temperature."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Zero-Heat-Flux', 'description': "This is a single arm study. All patients will have deep tissue temperature monitored from the nasopharyngeal and lateral forehead sites simultaneously.\n\nZero-heat-flux thermometry: The zero-heat-flux thermometer will be placed on the subject's lateral forehead for the duration of the surgery to measure deep tissue temperature."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '20', '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': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '5.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-01', 'studyFirstSubmitDate': '2012-08-16', 'resultsFirstSubmitDate': '2019-08-12', 'studyFirstSubmitQcDate': '2012-08-17', 'lastUpdatePostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-11', 'studyFirstPostDateStruct': {'date': '2012-08-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Temperature Difference in Degrees Celsius', 'timeFrame': 'Every 5 to 10 minutes, or as clinically indicated, for the duration of the surgery from the time of incision to the time of closure. The average duration of surgery was 57 minutes.', 'description': 'Body temperature difference as defined by Agreement (bias - Zero heat flux thermometry minus nasopharyngeal) between simultaneously-acquired nasopharyngeal and forehead deep tissue temperatures as assessed by Bland and Altman repeated measures technique.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Deep Tissue Temperature', 'Zero Heat Flux Thermometry', 'Thermometry', 'Core Temperature'], 'conditions': ['Body Temperature', 'Thermosensing', 'Temperature']}, 'referencesModule': {'references': [{'pmid': '19512860', 'type': 'BACKGROUND', 'citation': 'Langham GE, Maheshwari A, Contrera K, You J, Mascha E, Sessler DI. Noninvasive temperature monitoring in postanesthesia care units. Anesthesiology. 2009 Jul;111(1):90-6. doi: 10.1097/ALN.0b013e3181a864ca.'}, {'pmid': '21444968', 'type': 'BACKGROUND', 'citation': 'Teunissen LP, Klewer J, de Haan A, de Koning JJ, Daanen HA. Non-invasive continuous core temperature measurement by zero heat flux. Physiol Meas. 2011 May;32(5):559-70. doi: 10.1088/0967-3334/32/5/005. Epub 2011 Mar 28.'}, {'pmid': '5548025', 'type': 'BACKGROUND', 'citation': 'Fox RH, Solman AJ. A new technique for monitoring the deep body temperature in man from the intact skin surface. J Physiol. 1971 Jan;212(2):8P-10P. No abstract available.'}, {'pmid': '940402', 'type': 'BACKGROUND', 'citation': 'Togwa T, Nemoto T, Yamazaki T, Kobayashi T. A modified internal temperature measurement device. Med Biol Eng. 1976 May;14(3):361-4. doi: 10.1007/BF02478138. No abstract available.'}, {'pmid': '9104528', 'type': 'BACKGROUND', 'citation': 'Matsukawa T, Sessler DI, Ozaki M, Hanagata K, Iwashita H, Kumazawa T. Comparison of distal oesophageal temperature with "deep" and tracheal temperatures. Can J Anaesth. 1997 Apr;44(4):433-8. doi: 10.1007/BF03014466.'}, {'pmid': '11032273', 'type': 'BACKGROUND', 'citation': 'Harioka T, Matsukawa T, Ozaki M, Nomura K, Sone T, Kakuyama M, Toda H. "Deep-forehead" temperature correlates well with blood temperature. Can J Anaesth. 2000 Oct;47(10):980-3. doi: 10.1007/BF03024869.'}, {'pmid': '12903922', 'type': 'BACKGROUND', 'citation': 'Yamakage M, Namiki A. Deep temperature monitoring using a zero-heat-flow method. J Anesth. 2003;17(2):108-15. doi: 10.1007/s005400300026. No abstract available.'}, {'pmid': '652707', 'type': 'BACKGROUND', 'citation': "Jost U, Hanf K, Kohler CO, Just OH. [A new method for the transcutaneous measurement of deep body temperature during anaesthesia and intensive care (author's transl)]. Prakt Anaesth. 1978 Apr;13(2):144-9. German."}, {'pmid': '11419682', 'type': 'BACKGROUND', 'citation': 'Esamai F, Mining S, Forsberg P, Lewis DH. A comparison of brain, core and skin temperature in children with complicated and uncomplicated malaria. J Trop Pediatr. 2001 Jun;47(3):170-5. doi: 10.1093/tropej/47.3.170.'}, {'pmid': '17532957', 'type': 'BACKGROUND', 'citation': 'Akata T, Setoguchi H, Shirozu K, Yoshino J. Reliability of temperatures measured at standard monitoring sites as an index of brain temperature during deep hypothermic cardiopulmonary bypass conducted for thoracic aortic reconstruction. J Thorac Cardiovasc Surg. 2007 Jun;133(6):1559-65. doi: 10.1016/j.jtcvs.2006.11.031.'}, {'pmid': '14517632', 'type': 'BACKGROUND', 'citation': 'Yamakage M, Iwasaki S, Namiki A. Evaluation of a newly developed monitor of deep body temperature. J Anesth. 2002;16(4):354-7. doi: 10.1007/s005400200056. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Nasopharyngeal and deep tissue temperatures will be measured simultaneously during surgery and compared for agreement. The hypothesis of this trial is that deep tissue temperature as measured by zero-heat-flux thermometry will agree with nasopharyngeal temperatures during surgery.', 'detailedDescription': 'The core temperature of the body normally decreases in response to anesthesia. Deep tissue temperature can be used to estimate of body core temperature. Deep tissue temperature of the forehead will be measured using a new technology known as zero-heat-flux thermometry. The usual way to measure internal body temperature is within the nasal cavity (nasopharyngeal temperature). Nasopharyngeal and deep tissue temperatures will be measured simultaneously during surgery and compared for agreement. The hypothesis of this trial is that deep tissue temperature as measured by zero-heat-flux thermometry will agree with nasopharyngeal temperatures during surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Less than or equal to 17 years old\n* patients undergoing surgery during which core temperature is estimated\n* Willing to participate in trial\n* Able to provide consent\n* Adequate forehead surface area available for probe attachment\n* Urology, orthopedic, or general abdominal surgery\n\nExclusion Criteria:\n\n* Skin lesions at thermometer target site\n* Infectious disease\n* Bleeding disorder\n* Prone intraoperative positioning anticipated\n* Head and neck procedures\n* Cardiothoracic procedures\n* Tonsillectomy, cosmetic, or other brief surgical or nonsurgical procedures'}, 'identificationModule': {'nctId': 'NCT01670760', 'briefTitle': 'Zero Heat Flux Thermometry System Comparison Trial', 'organization': {'class': 'INDUSTRY', 'fullName': '3M'}, 'officialTitle': '3M(TM)SpotOn(TM) Temperature Monitoring System Thermometry Trial', 'orgStudyIdInfo': {'id': '2012-DTT-BS-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zero-Heat-Flux', 'description': 'This is a single arm study. All patients will have deep tissue temperature monitored from the nasopharyngeal and lateral forehead sites simultaneously.', 'interventionNames': ['Device: Zero-heat-flux thermometry']}], 'interventions': [{'name': 'Zero-heat-flux thermometry', 'type': 'DEVICE', 'otherNames': ['3M(TM) SpotOn(TM) temperature monitoring system'], 'description': "The zero-heat-flux thermometer will be placed on the subject's lateral forehead for the duration of the surgery to measure deep tissue temperature.", 'armGroupLabels': ['Zero-Heat-Flux']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15241', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburg of the University of Pittsburgh Medical Center", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Peter J Davis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '3M', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}