Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-02-24 @ 8:25 AM
Study NCT ID:
NCT05996757
Status:
COMPLETED
Last Update Posted:
2023-08-18
First Post:
2023-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Wet Clothing Removal Compared to Use of a Vapor Barrier in Accidental Hypothermia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}, {'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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-10', 'studyFirstSubmitDate': '2023-08-10', 'studyFirstSubmitQcDate': '2023-08-10', 'lastUpdatePostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean skin temperature', 'timeFrame': '60 minutes', 'description': 'Change in mean skin temperature during rewarming phase'}], 'secondaryOutcomes': [{'measure': 'Subjective thermal comfort and shivering', 'timeFrame': '60 minutes', 'description': 'Using a validated questionnaire at regular intervals'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Accidental hypothermia', 'Mountain Medicine'], 'conditions': ['Accidental Hypothermia', 'Emergencies']}, 'referencesModule': {'references': [{'pmid': '25712295', 'type': 'RESULT', 'citation': 'Henriksson O, Lundgren PJ, Kuklane K, Holmer I, Giesbrecht GG, Naredi P, Bjornstig U. Protection against cold in prehospital care: wet clothing removal or addition of a vapor barrier. Wilderness Environ Med. 2015 Mar;26(1):11-20. doi: 10.1016/j.wem.2014.07.001.'}, {'pmid': '38273259', 'type': 'DERIVED', 'citation': 'Hagen LT, Brattebo G, Dipl-Math JA, Wiggen O, Osteras O, Mydske S, Thomassen O. Effect of wet clothing removal on skin temperature in subjects exposed to cold and wrapped in a vapor barrier: a human, randomized, crossover field study. BMC Emerg Med. 2024 Jan 25;24(1):18. doi: 10.1186/s12873-024-00937-8.'}]}, 'descriptionModule': {'briefSummary': 'The optimal method of prehospital insulation and rewarming of hypothermic patients have been subject of debate, and there is a substantial lack og high-quality evidence to guide providers.\n\nOne question concerns whether or not the patients clothing should be removed prior to being wrapped in an insulating model with a vapor barrier. Evaporative heat loss is one of four mechanisms of heat loss, and preventing evaporative heat loss should be a prioritized task for providers. Removal of wet clothing usually means subjecting the patient to the environment, but will reduce the evaporative heat loss considerably. An other alternative is to encapsulate the patient in a vapor barrier. Evaporative heat loss will stop when the humidity inside the vapor barrier reaches 100%.\n\nWe aim to investigate whether it is recommended to removed wet clothing or encase the patient in a vapor barrier.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\<18\n* American Society of Anaesthesiologists class 1\n* No nicotine use\n\nExclusion Criteria:\n\n* Acute illness on study day, fever or malaise'}, 'identificationModule': {'nctId': 'NCT05996757', 'briefTitle': 'Effect of Wet Clothing Removal Compared to Use of a Vapor Barrier in Accidental Hypothermia', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': 'Effect of Wet Clothing Removal in the Treatment of Accidental Hypothermia: A Human Crossover Field Study', 'orgStudyIdInfo': {'id': '2017/150'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Wet clothing removal', 'interventionNames': ['Procedure: Wet clothing removal']}, {'type': 'NO_INTERVENTION', 'label': 'Vapor barrier'}], 'interventions': [{'name': 'Wet clothing removal', 'type': 'PROCEDURE', 'description': 'The participants in the intervention group will have their clothing removed prior to insulation.', 'armGroupLabels': ['Wet clothing removal']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bergen', 'country': 'Norway', 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'Øyvind Thomassen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Haukeland University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}