Hypothermia Due to Cold EnvironmentNCT07450092
Prehospital Use of Forced Air Warming
A study testing Forced air warming in people with Hypothermia Due to Cold Environment, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypothermia Due to Cold Environment
- What is being tested?
- Forced air warming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteNorway
- Study dates
- 10 Mar 2026to 11 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: Participant must be over 18 and under 45 years of age at the time of signing the informed consent.
- 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.
- Weight: BMI under 30 kg/m2
- 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.
- 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.
Who cannot join
- 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).
- History of drug dependency: Recent head injury (last. 12 months), known increased ICP, seizures or epilepsy
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prehospital Use of Forced Air Warming for Treatment of Accidental Hypothermia - A Pilot Study
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.
Read the detailed description
Accidental hypothermia is defined as an involuntary drop in core body temperature below 35°C.
Hypothermia 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.
When 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.
Until 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.
Given 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.
One 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.
Standardization 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.
Inhibition 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.
- Conditions
- Hypothermia Due to Cold Environment
- Being tested
- Forced air warming
- Keywords
- hypothermia, accidental hypothermia, mountain medicine
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forced air warmingDevice
Prehospital use of forced air warming
| Study group | Role | What they receive |
|---|---|---|
| Forced air warming group | Experimental | All participants. Receives: Device: Forced air warming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal temperature
Changes in body temperature of participants measured in the esophagus
Measured: 1 hour
Secondary outcomes (6)
Feasibility of the experimental procedure
Practical problems involving the experimental design.
Measured: 3 hours
Air temperature
We will measure the temperature of the air warming the patient.
Measured: 1 hour
Air velocity
We will measure the air velocity entering the wrap where the patient is placed.
Measured: 1 hour
Air particle concentration
We will measure the amounts of oxygen (o2) and carbon dioxide (CO2) in the warmed air.
Measured: 1 hour
Subjective comfort
We will regularly ask the participants how they are feeling using a validated subjective scoring form.
Measured: 3 hours
Ambient air temperature
We will measure the temperature in the cold chamber continously
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start10 Mar 2026 (estimated)
- Primary completion11 Mar 2026 (estimated)
- Study completion11 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypothermia Due to Cold EnvironmentStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study to investigate feasibility
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450092
- Sponsor's protocol ID
- 2026/963234
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: GDPR
Publications
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.
PubMed 38664809
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehospital Use of Forced Air Warming for Treatment of Accidental Hypothermia - A Pilot Study
- ClinicalTrials.gov ID
- NCT07450092
- Acronym / sponsor ID
- 2026/963234
- Conditions
- Hypothermia Due to Cold Environment
- Keywords
- hypothermia, accidental hypothermia, mountain medicine
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 10 Mar 2026 (estimated)
- Primary completion
- 11 Mar 2026 (estimated)
- Study completion
- 11 Mar 2026 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Accidental hypothermia is defined as an involuntary drop in core body temperature below 35°C.
Hypothermia 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.
When 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.
Until 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.
Given 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.
One 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.
Standardization 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.
Inhibition 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study to investigate feasibility
| Arm | Type | Receives |
|---|---|---|
| Forced air warming group | Experimental | Device: Forced air warmingAll participants. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: Participant must be over 18 and under 45 years of age at the time of signing the informed consent.
- 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.
- Weight: BMI under 30 kg/m2
- 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.
- 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.
Key exclusion criteria (3 listed)
- 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).
- History of drug dependency: Recent head injury (last. 12 months), known increased ICP, seizures or epilepsy
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forced air warmingPrehospital use of forced air warming | Device | Forced air warming group |
Primary outcome
Esophageal temperature
Time frame: 1 hour
Changes in body temperature of participants measured in the esophagus
6 secondary outcomes
Feasibility of the experimental procedure
Time frame: 3 hours
Air temperature
Time frame: 1 hour
Air velocity
Time frame: 1 hour
Air particle concentration
Time frame: 1 hour
Subjective comfort
Time frame: 3 hours
Ambient air temperature
Time frame: 3 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Background: PubMed 38664809Mydske 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.
- Individual participant dataSharing planned: No. GDPR
Related trials for Hypothermia Due to Cold Environment
Enrolling by invitation
Pulmonary Function by Litter Position
Hypothermia Due to Cold Environment, Trauma Patients
Enrolling by invitation
Clinical Evaluation of Effectiveness of the "Therm'Up" Heating Device
Hypothermia Due to Cold Environment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forced air warming in people with Hypothermia Due to Cold Environment, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophageal temperature (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07450092, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.