Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-02-18 @ 5:49 PM
Study NCT ID:
NCT02353793
Status:
COMPLETED
Last Update Posted:
2016-11-29
First Post:
2014-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trauma Patients and Hypothermia in the Emergency Room: ReadyHeat® Versus Cotton Wool Blanket
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-26', 'studyFirstSubmitDate': '2014-12-15', 'studyFirstSubmitQcDate': '2015-02-02', 'lastUpdatePostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body core temperature at the end of completed emergency room treatment', 'timeFrame': 'When handing the patient over to the next caring unit (ICU, operating theatre etc.) n most cases an average time frame < 60 min is maintained', 'description': 'Body core temperature taken after completed emergency room treatment incl. imaging. In most cases an average time frame \\< 60 min is maintained.'}], 'secondaryOutcomes': [{'measure': 'Body core temperature during emergency room treatment', 'timeFrame': 'Temperature measurement: Admission, after 15, 30, 45 minutes', 'description': 'Body core temperature taken after emergency room admission and 15, 30 and 45 minutes after beginning of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypothermia', '(Poly) Trauma', 'Emergency Room', 'Warming Blanket'], 'conditions': ['Hypothermia', 'Trauma']}, 'referencesModule': {'references': [{'pmid': '22487163', 'type': 'BACKGROUND', 'citation': "Curry N, Davis PW. What's new in resuscitation strategies for the patient with multiple trauma? Injury. 2012 Jul;43(7):1021-8. doi: 10.1016/j.injury.2012.03.014. Epub 2012 Apr 7."}, {'pmid': '18648241', 'type': 'BACKGROUND', 'citation': 'Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76.'}, {'pmid': '23832738', 'type': 'BACKGROUND', 'citation': 'Kapan M, Onder A, Oguz A, Taskesen F, Aliosmanoglu I, Gul M, Tacyildiz I. The effective risk factors on mortality in patients undergoing damage control surgery. Eur Rev Med Pharmacol Sci. 2013 Jun;17(12):1681-7.'}]}, 'descriptionModule': {'briefSummary': 'Hypothermia is a common problem in traumatized patients leading to severe complications such as impaired coagulation, increased rate of wound infections and overall patient discomfort among others. Therefore, the investigators test out the new self warming ReadyHeat® blanket device against the currently used cotton wool blanket in terms of effects on the prevention and treatment of hypothermia.', 'detailedDescription': 'Hypothermia is a common problem in traumatized patients leading to severe complications such as impaired coagulation, increased rate of wound infections and overall patient discomfort among others. Therefore, the investigators test out the new self warming (via an exothermic reaction) ReadyHeat® blanket device against the currently used cotton wool blanket in terms of effects on the prevention and treatment of hypothermia. Near body core temperature is measured by a sublingual sensor as the "gold standard" of body core temperature measurement - the pulmonary artery catheter - is too invasive and not suited for this collective of patients in the emergency room setting. Blanket use will be randomized. Temperature will be taken at emergency room admission, after 15, 30 and 45 minutes of treatment as well as right before handing the patient over to the next caring unit (ICU, IMC, operating theatre etc.). If treatment time is shorter than expected measurement will stop at the latest possible point. Blankets will be applied to the patient once admission in the emergency room is complete and will only be lifted for interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Trauma patients ≥ 18 years of all severity stages including poly traumatized patients admissioned through the emergency room\n\nExclusion Criteria:\n\n* Patients \\< 18 years\n* Patients after pre-hospital cardiac arrest or ongoing CPR at time of admission'}, 'identificationModule': {'nctId': 'NCT02353793', 'briefTitle': 'Trauma Patients and Hypothermia in the Emergency Room: ReadyHeat® Versus Cotton Wool Blanket', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Schleswig-Holstein'}, 'officialTitle': 'Trauma Patients and Hypothermia in the Emergency Room: a Trial Between Self-warming ReadyHeat® Blanket and Traditional Cotton Wool Blanket', 'orgStudyIdInfo': {'id': 'ReadyHeat'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ReadyHeat® blanket', 'description': 'Patient warming with ReadyHeat® blanket', 'interventionNames': ['Device: ReadyHeat® blanket']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cotton wool blanket', 'description': 'Patient warming with cotton wool blanket', 'interventionNames': ['Device: Cotton wool blanket']}], 'interventions': [{'name': 'ReadyHeat® blanket', 'type': 'DEVICE', 'description': 'Using ReadyHeat® blanket for patient warming', 'armGroupLabels': ['ReadyHeat® blanket']}, {'name': 'Cotton wool blanket', 'type': 'DEVICE', 'description': 'Using cotton wool blanket for patient warming', 'armGroupLabels': ['Cotton wool blanket']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24105', 'city': 'Kiel', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'University Hospital Schleswig-Holstein, Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}], 'overallOfficials': [{'name': 'Jan Höcker, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Klinik für Anästhesiologie und Operative Intensivmedizin, Arnold-Heller-Str. 3, Haus 12, 24105 Kiel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Schleswig-Holstein', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Timo Iden', 'investigatorAffiliation': 'University Hospital Schleswig-Holstein'}}}}