Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 3:05 AM
Study NCT ID:
NCT07450092
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-03-04
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prehospital Use of Forced Air Warming
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pilot study to investigate feasibility'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2026-03-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-03-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Esophageal temperature', 'timeFrame': '1 hour', 'description': 'Changes in body temperature of participants measured in the esophagus'}], 'secondaryOutcomes': [{'measure': 'Feasibility of the experimental procedure', 'timeFrame': '3 hours', 'description': 'Practical problems involving the experimental design.'}, {'measure': 'Air temperature', 'timeFrame': '1 hour', 'description': 'We will measure the temperature of the air warming the patient.'}, {'measure': 'Air velocity', 'timeFrame': '1 hour', 'description': 'We will measure the air velocity entering the wrap where the patient is placed.'}, {'measure': 'Air particle concentration', 'timeFrame': '1 hour', 'description': 'We will measure the amounts of oxygen (o2) and carbon dioxide (CO2) in the warmed air.'}, {'measure': 'Subjective comfort', 'timeFrame': '3 hours', 'description': 'We will regularly ask the participants how they are feeling using a validated subjective scoring form.'}, {'measure': 'Ambient air temperature', 'timeFrame': '3 hours', 'description': 'We will measure the temperature in the cold chamber continously'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypothermia', 'accidental hypothermia', 'mountain medicine'], 'conditions': ['Hypothermia Due to Cold Environment']}, 'referencesModule': {'references': [{'pmid': '38664809', 'type': 'BACKGROUND', 'citation': 'Mydske S, Brattebo G, Osteras O, Wiggen O, Assmus J, Thomassen O. Effect of a vapor barrier in combination with active external rewarming for cold-stressed patients in a prehospital setting: a randomized, crossover field study. Scand J Trauma Resusc Emerg Med. 2024 Apr 25;32(1):35. doi: 10.1186/s13049-024-01204-2.'}]}, 'descriptionModule': {'briefSummary': 'Forced air warming may be a feasible strategy for prehospital rewarming of patients with accidental hypothermia. This pilot study will explore the feasibility of this technique which has not been studied outside of hospital.', 'detailedDescription': 'Accidental hypothermia is defined as an involuntary drop in core body temperature below 35°C.\n\nHypothermia is a risk factor for cardiac arrythmia, pulmonary oedema, coagulopathy and neurological pathology. Isolated accidental hypothermia is potentially lethal on its own, and it is also an independent risk factor for increased mortality in patients with traumatic injury.\n\nWhen core temperature drops, the body will automatically activate compensatory mechanisms in order to both increase thermic production and minimize heat loss in order to restore normal temperature. The mechanisms for thermal homeostasis are complex, strictly regulated and effective.\n\nUntil quite recently, active external rewarming was considered to be harmful and dangerous for patients with accidental hypothermia. A fear of fatal complications such as increased afterdrop and "rearming syndrome" leading to dangerous arrythmias and a drop in blood pressure which in a worstcase scenario could lead to circulatory collapse, shock and potentially death.\n\nGiven the potentially detrimental consequences of being cold, any advice to abstain from warming patients should be well-documented, and the adverse effects of warming should outweigh those of being hypothermic. The lack of evidence for this claim that active external rewarming is dangerous along with many reports of successful external rewarming is leading to a change in most guidelines where active external rewarming is now an advisable treatment option. A variety of different technological devices exist for the purpose of rewarming, but there is no established standard which is proven superior to others. Several trials have compared different rewarming methods, but evidence is limited. There is particularly deficient evidence regarding the amount of heat available for transfer from different methods and also the required amount of heat transfer for the rewarming to have a significant clinical impact. There is however reason to be cautious with active external rewarming of hypothermic patients. In a normothermic patient with normal circulatory function, thermal energy will be absorbed by the blood which flows back into central circulation distributing the heat evenly into a large volume. In a hypothermic patient there will be less cutaneous blood flow and less heat will be transferred to systemic circulation. This means that heat will accumulate on the skin surface and increase the risk of cutaneous injury, and there are several reported cases of this. Hypothermia research with volunteer research participants is a complicated matter for many reasons.\n\nOne complicating factor is shivering, which is an autonomic defense mechanism in which the muscles contract rapidly producing heat. It is the most effective method for the body to increase the metabolic heat production and re-establish normothermia. The shivering response is complicated in a research setting because there is a large interindividual variation in temperature threshold for initiation of shivering and in shivering intensity. This means that if research participants are cooled down they will start to shiver at different core temperatures and with different intensities.\n\nStandardization of data is therefore impossible, and the researcher will be measuring the interindividual shivering abilities of the different research participants instead of the effect of the intervention. Shivering must therefore be inhibited in order to achieve reliable data.\n\nInhibition of shivering for research has been done several times before. The most common method to achieve this is through intravenous administration of a drug called Meperidine which is a synthetic opioid with good shivering inhibition attributes. A protocol for inhibition of shivering in patients with simulated accidental hypothermia has been developed by Helland et. al., which we intend to use in this experiment. Given the results of our previous studies (REK 714469 and REK 855256, results not yet published) where we have documented limited effects of traditional treatment options in non-shivering participants, we believe that alternative strategies must be investigated. Forced Air Warming (FAW) is a commonly used method for rewarming from hypothermia in an in-hospital setting, but it has limited evidence for prehospital use. FAW enables heat transfer to a much larger surface area compared to, for example, an electric heating blanket, which may contribute to significantly higher rewarming rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: Participant must be over 18 and under 45 years of age at the time of signing the informed consent.\n* Type of Participant and Disease Characteristics: Participants who are overtly healthy as determined by their medical history. The participants will be asked to fill out a health report stating to be healthy, using no relevant medication, and having no relevant allergies or hypersensitivity to the active substances or to any of the excipients of the medications used.\n* Weight: BMI under 30 kg/m2\n* Sex and Contraceptive/Barrier Requirements: Both male and female participants can be included. Female participants of childbearing potential will be asked to take a pregnancy test to confirm the absence of pregnancy prior to study drug administration on both visit 1 and 2.\n* Informed Consent: Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria:\n\n* Drugs: Concomitant use of sedatives, MAO-inhibitors, SSRI, ritonavir, cimetidine, chlorpromazine, phenytoin, erythromycin, itraconazole, platelet inhibitors, Apomorphine, alcohol (during the trial period) or other opioids or opioid antagonists (during the trial period).\n* History of drug dependency: Recent head injury (last. 12 months), known increased ICP, seizures or epilepsy\n* Other: Known reduced liver- or kidney function, reduced respiratory drive, known supraventricular tachycardia or prolonged QTc, hypertrophy of the prostate or urinary constriction, ongoing pregnancy or breastfeeding. Known acute glaucoma, myasthenia gravis. History of cold injuries or frostbites.'}, 'identificationModule': {'nctId': 'NCT07450092', 'briefTitle': 'Prehospital Use of Forced Air Warming', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': 'Prehospital Use of Forced Air Warming for Treatment of Accidental Hypothermia - A Pilot Study', 'orgStudyIdInfo': {'id': '2026/963234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Forced air warming group', 'description': 'All participants.', 'interventionNames': ['Device: Forced air warming']}], 'interventions': [{'name': 'Forced air warming', 'type': 'DEVICE', 'description': 'Prehospital use of forced air warming', 'armGroupLabels': ['Forced air warming group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5022', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'GDPR'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}