Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-03-06 @ 8:52 AM
Study NCT ID:
NCT02009059
Status:
UNKNOWN
Last Update Posted:
2015-10-29
First Post:
2013-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of Non-invasive Temperature Measurement in Deep Hypothermia
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-28', 'studyFirstSubmitDate': '2013-11-11', 'studyFirstSubmitQcDate': '2013-12-06', 'lastUpdatePostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Temperature in degrees celsius', 'timeFrame': 'The patients will be followed during the induced per-operative hypothermia, an expected average of 1,5 hours.', 'description': 'The temperature reading from the epitympanic thermometer will be recorded every two minutes during deep hypothermia and compared to the temperature measured in the cardiopulmonary bypass circuit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hypothermia', 'Temperature', 'epitympanic', 'pre-hospital'], 'conditions': ['Hypothermia']}, 'descriptionModule': {'briefSummary': 'In pre-hospital care, there are few non-invasive thermometers that are proved both robust and accurate. The aim of this study is to investigate the accuracy of a certain ear-canal based thermometer on patients undergoing thoracic surgery in deep hypothermia.', 'detailedDescription': 'The study is a prospective cohort study on patients undergoing elective thoracic surgery in deep hypothermia. The goal is to assess the accuracy of non-invasive temperature devices compared to a gold standard representing core temperature.\n\nAt the study hospital, Oslo University Hospital Rikshospitalet, patients undergoing thoracic surgery will already have several routes of temperature monitoring as part of standard procedure. Before cardiopulmonary bypass bladder temperature is normally used as a reference for core temperature. After cardiopulmonary bypass is established, temperature is monitored directly in the circulating blood, hence reflecting core temperature.\n\nFor measuring the epitympanic temperature we will use the Metraux Epitympanic Thermometer (Walpoth, Galdikas et al. 1994), a nasopharyngeal temperature probe (Mon-a-Therm, General Purpose Temperature Probe 12Fr/Ch, Covidien) and a new transcutaneous device (SpotOn 3M). The temperature will be measured in degrees Celsius. The first reading will be noted just after induction of anaesthesia and compared to the bladder temperature. After cardiopulmonary bypass (CPB) is established and therapeutic hypothermia is induced, the values for both non-invasive and blood temperature will be recorded every minute. After reaching the target temperature according to the blood temperature, we will continue recording the non-invasive temperature until relative similarity is established. The process will be repeated during re-warming.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing elective thoracic surgery in deep hypothermia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult \\>18 years\n* Elektive cardiac surgery in deep hypothermia\n* No pathology in ear canal on otoscopy\n\nExclusion Criteria:\n\n* Pathology in ear canal\n* non-consent'}, 'identificationModule': {'nctId': 'NCT02009059', 'briefTitle': 'Accuracy of Non-invasive Temperature Measurement in Deep Hypothermia', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Accuracy of Non-invasive Temperature Measurement in Deep Hypothermia; a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'scs-2013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-invasive temperature in hypothermia', 'description': 'Adult patients undergoing elective thoracic surgery in deep hypothermia', 'interventionNames': ['Device: Non-invasive temperature in hypothermia']}], 'interventions': [{'name': 'Non-invasive temperature in hypothermia', 'type': 'DEVICE', 'otherNames': ['metraux epitympanic, nasopharyngeal, 3M spotOn'], 'description': 'accuracy of non-invasive temperature measurement in deep hypothermia compared to core temperature', 'armGroupLabels': ['Non-invasive temperature in hypothermia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0372', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital, Rikshospitalet', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Leiv Arne Rosseland, MD, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}