Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT04489927
Status:
TERMINATED
Last Update Posted:
2023-08-22
First Post:
2020-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of the Measurement Accuracy of the Tcore Thermometer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001832', 'term': 'Body Temperature Changes'}], 'ancestors': [{'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': 'ACTUAL', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'whyStopped': "Patients couldn't be recruited (no patients with fewer available)", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-17', 'studyFirstSubmitDate': '2020-07-24', 'studyFirstSubmitQcDate': '2020-07-27', 'lastUpdatePostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Temperature', 'timeFrame': 'within 24 hours', 'description': 'Temperature measurements with reference thermometer Tcore®'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Temperature Change, Body']}, 'descriptionModule': {'briefSummary': 'The aim of the study conducted at the UKSH is to investigate the measuring accuracy of the body core temperature thermometer Tcore®. Therefore the bias of the measurements to the reference measurements of the bladder catheter thermometer is determined.', 'detailedDescription': 'The aim of the study conducted at the UKSH is to investigate the measuring accuracy of the body core temperature thermometer Tcore®. Therefore the bias of the measurements to the reference measurements of the bladder catheter thermometer is determined.\n\nPatients included are in the ICU of the UKSH and awake. They already have the reference thermometer in the catheter. The patient investigation time is limited to maximum 2 hours, SAEs will be recorded for 24 hours. The temperature of the two temperature sensors will be compared on three timepoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients in the ICU of the University Hospital Schleswig-Holstein', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body temperature \\> 34 °C\n* Signed consent\n* Bladder catheter with temperature sensor\n\nExclusion Criteria:\n\n* Inflammation of the frontal sinus or the measuring point of the reference measurement (bladder)\n* Skin irritation to the adhesive or other materials used\n* medication that locally affects the body temperature or the temperature of the reference body site (barbiturates, thyroid preparations, antipsychotics, new vaccines, aspirin, acetaminophen, ibuprofen, or similar)\n* Taking antipyretics in the last 120 minutes before measurement'}, 'identificationModule': {'nctId': 'NCT04489927', 'acronym': 'T-CORE-PMCF', 'briefTitle': 'Validation of the Measurement Accuracy of the Tcore Thermometer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Drägerwerk AG & Co. KGaA'}, 'officialTitle': 'Validierung Der Messgenauigkeit Des Tcore Thermometers in Der Anwendung Nicht-invasiver Temperaturmessung gegenüber herkömmlicher Invasiver Messung Auf Der Intensivstation Bei Wachen Patienten', 'orgStudyIdInfo': {'id': 'Tcore-PMCF'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tcore', 'type': 'DEVICE', 'description': 'Temperature Measurement of standard care versus the Tcore measurement'}]}, 'contactsLocationsModule': {'locations': [{'zip': '23538', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'University Schleswig-Holstein', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}], 'overallOfficials': [{'name': 'Tobias Graf, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Schleswig-Holstein Lübeck'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Drägerwerk AG & Co. KGaA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}