Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-03-01 @ 4:45 PM
Study NCT ID:
NCT02031159
Status:
COMPLETED
Last Update Posted:
2014-05-16
First Post:
2014-01-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation, Accuracy, Precision and Practicability of Zero Heat Flux Temperature Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-15', 'studyFirstSubmitDate': '2014-01-01', 'studyFirstSubmitQcDate': '2014-01-07', 'lastUpdatePostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'body core temperature (°C)', 'timeFrame': 'body core temperature taken at 75 min after induction of anesthesia'}], 'primaryOutcomes': [{'measure': 'body core temperature (°C)', 'timeFrame': 'body core temperature taken at 15 min after induction of anesthesia'}], 'secondaryOutcomes': [{'measure': 'body core temperature (°C)', 'timeFrame': 'body core temperature taken at 45 min after induction of anesthesia'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['perioperative hypothermia', 'zero heat flux', 'non-invasive measurement of body core temperature'], 'conditions': ['Hypothermia']}, 'referencesModule': {'references': [{'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': '25693138', 'type': 'DERIVED', 'citation': 'Iden T, Horn EP, Bein B, Bohm R, Beese J, Hocker J. Intraoperative temperature monitoring with zero heat flux technology (3M SpotOn sensor) in comparison with sublingual and nasopharyngeal temperature: An observational study. Eur J Anaesthesiol. 2015 Jun;32(6):387-91. doi: 10.1097/EJA.0000000000000232.'}]}, 'descriptionModule': {'briefSummary': 'Hypothermia is common in patients undergoing general anesthesia. There have been several negative outcomes reported. Zero heat flux is a non-invasive method for measurement of body core temperature. The aim of this study is to see if this method is comparable in terms of correlation, accuracy, precision and practicability to commonly used sublingual and nasopharyngeal temperature monitoring.', 'detailedDescription': 'Hypothermia is common in patients undergoing general anesthesia. There have been several negative outcomes reported such as bleeding, infection rate, cardiac complications, prolonged wound healing and patient discomfort. Zero heat flux is a non-invasive method for measurement of body core temperature. The aim of this study is to see if this method is comparable in terms of correlation, accuracy, precision and practicability to commonly used sublingual and nasopharyngeal temperature monitoring. Measurements are performed with the SpotOn® sensor by Arizant Healthcare, Inc..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients older than 16 years undergoing elective surgery in either gynecology or trauma surgery with a planned surgery time \\> 60 min.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* elective surgery in gynecology or trauma surgery\n* planned surgery time \\> 60 min\n* patients older than 16 years\n\nExclusion Criteria:\n\n* emergency surgery\n* need for post-surgery ventilation\n* patient's denial to take part in the study"}, 'identificationModule': {'nctId': 'NCT02031159', 'briefTitle': 'Correlation, Accuracy, Precision and Practicability of Zero Heat Flux Temperature Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Schleswig-Holstein'}, 'officialTitle': 'Correlation, Accuracy, Precision and Practicability of Zero Heat Flux Method in Comparison With Sublingual and Nasopharyngeal Temperature Measurement', 'orgStudyIdInfo': {'id': 'THER-ZeroHeatFlux'}}, 'contactsLocationsModule': {'locations': [{'zip': '24105', 'city': 'Kiel', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Anästhesiologie und Operative Intensivmedizin', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}], 'overallOfficials': [{'name': 'Jan Hoecker, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Klinik fur Anästhesiologie und Operative Intensivmedizin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Schleswig-Holstein', 'class': 'OTHER'}, 'collaborators': [{'name': '3M', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. Jan Höcker', 'investigatorFullName': 'PD Dr. Jan Hoecker', 'investigatorAffiliation': 'University Hospital Schleswig-Holstein'}}}}