Accidental HypothermiaNCT06855173
Active External Rewarming from Accidental Hypothermia - a Dose-response Pilot Study
A study testing Active external rewarming device, Active external rewarming device 2 and Active external rewarming device 3 in people with Accidental Hypothermia, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The aim of this pilot study is to evaluate if there is a dose-response relationship between the use of active external rewarming devices and core temperature rewarming rate from simulated accidental hypothermia. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Accidental Hypothermia
- What is being tested?
- Active external rewarming device, Active external rewarming device 2 and Active external rewarming device 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNorway
- Study dates
- 11 Mar 2025to 12 Mar 2025
- 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
- Healthy
Who cannot join
- Normal BMI
- Smoking
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
The aim of this pilot study is to evaluate if there is a dose-response relationship between the use of active external rewarming devices and core temperature rewarming rate from simulated accidental hypothermia. Volunteer research participants will be cooled in a field laboratory, and they will recieve medications to inhibit shivering, enabeling a drop in core temperature. Subsequently, they will be treated with either one, two or four heating blankets, and analyses will be performed to investigate whether we are able to find a difference between the three groups.
Read the detailed description
The aim of this pilot study is to evaluate if there is a dose-response relationship between the use of active external rewarming devices and core temperature rewarming rate from simulated accidental hypothermia. Volunteer research participants will be cooled in a field laboratory, and they will recieve medications to inhibit shivering, enabeling a drop in core temperature. All participants will be monitored extensively using a trans-nasal esophageal temperature probe, ECG, SpO2, Blood pressure, skin temperature and with subjective scores. After the cooling phase, the participants will be treated with either one, two or four heating blankets assigned in a randomized order, and analyses will be performed to investigate whether we are able to find a difference between the three groups.
- Conditions
- Accidental Hypothermia
- Being tested
- Active external rewarming device, Active external rewarming device 2, Active external rewarming device 3, Active external rewarming device 4
- Keywords
- hypothermia, active external rewarming
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active external rewarming deviceDevice
Electrical heating blanket
Active external rewarming device 2Device
Electrical heating blanket
Active external rewarming device 3Device
Electric heating blanket
Active external rewarming device 4Device
Electric heating blanket
| Study group | Role | What they receive |
|---|---|---|
| One active external rewarming device | Experimental | Participants in this group will recieve one active external rewarming device Receives: Device: Active external rewarming device |
| Two active external rewarming devices | Experimental | Participants in this group will recieve two active external rewarming devices Receives: Device: Active external rewarming device; Device: Active external rewarming device 2 |
| Four active external rewarming devices | Experimental | Participants in this group will recieve four active external rewarming devices Receives: Device: Active external rewarming device; Device: Active external rewarming device 2; Device: Active external rewarming device 3; Device: Active external rewarming device 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal temperature rewarming rate
Developement of esophageal temperature during the rewarming phase after cooling. Participants will be shiver-inhibited in this phase of the trial
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start11 Mar 2025 (estimated)
- Primary completion12 Mar 2025 (estimated)
- Study completion12 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental HypothermiaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Øyvind Thomassen, MD, PhD, Study director, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855173
- Sponsor's protocol ID
- 2025/855256
- Other IDs
- 2025
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Risk of identifiable data due to a low number of participants
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active External Rewarming from Accidental Hypothermia - a Dose-response Pilot Study
- ClinicalTrials.gov ID
- NCT06855173
- Acronym / sponsor ID
- 2025/855256
- Conditions
- Accidental Hypothermia
- Keywords
- hypothermia, active external rewarming
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 11 Mar 2025 (estimated)
- Primary completion
- 12 Mar 2025 (estimated)
- Study completion
- 12 Mar 2025 (estimated)
- First posted
- 3 Mar 2025 (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.
The aim of this pilot study is to evaluate if there is a dose-response relationship between the use of active external rewarming devices and core temperature rewarming rate from simulated accidental hypothermia. Volunteer research participants will be cooled in a field laboratory, and they will recieve medications to inhibit shivering, enabeling a drop in core temperature. Subsequently, they will be treated with either one, two or four heating blankets, and analyses will be performed to investigate whether we are able to find a difference between the three groups.
Detailed description
The aim of this pilot study is to evaluate if there is a dose-response relationship between the use of active external rewarming devices and core temperature rewarming rate from simulated accidental hypothermia. Volunteer research participants will be cooled in a field laboratory, and they will recieve medications to inhibit shivering, enabeling a drop in core temperature. All participants will be monitored extensively using a trans-nasal esophageal temperature probe, ECG, SpO2, Blood pressure, skin temperature and with subjective scores. After the cooling phase, the participants will be treated with either one, two or four heating blankets assigned in a randomized order, and analyses will be performed to investigate whether we are able to find a difference between the three groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| One active external rewarming device | Experimental | Device: Active external rewarming deviceParticipants in this group will recieve one active external rewarming device |
| Two active external rewarming devices | Experimental | Device: Active external rewarming device, Device: Active external rewarming device 2Participants in this group will recieve two active external rewarming devices |
| Four active external rewarming devices | Experimental | Device: Active external rewarming device, Device: Active external rewarming device 2, Device: Active external rewarming device 3, Device: Active external rewarming device 4Participants in this group will recieve four active external rewarming devices |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy
Key exclusion criteria (2 listed)
- Normal BMI
- Smoking
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 |
|---|---|---|
| Active external rewarming deviceElectrical heating blanket | Device | Four active external rewarming devices, One active external rewarming device, Two active external rewarming devices |
| Active external rewarming device 2Electrical heating blanket | Device | Four active external rewarming devices, Two active external rewarming devices |
| Active external rewarming device 3Electric heating blanket | Device | Four active external rewarming devices |
| Active external rewarming device 4Electric heating blanket | Device | Four active external rewarming devices |
Primary outcome
Esophageal temperature rewarming rate
Time frame: 1 hour
Developement of esophageal temperature during the rewarming phase after cooling. Participants will be shiver-inhibited in this phase of the trial
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 3 Mar 2025.
- Individual participant dataSharing planned: Undecided. Risk of identifiable data due to a low number of participants
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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.
Øyvind Thomassen, MD, PhD study director
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active external rewarming device, Active external rewarming device 2 and Active external rewarming device 3 in people with Accidental Hypothermia, 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 1 inclusion and 2 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 3 Mar 2025. 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 rewarming rate (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2025; AzTrials last refreshed its copy on 30 Oct 2026.