Active External Rewarming from Accidental Hypothermia - a Dose-response Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active external rewarming device, Active external rewarming device 2, Active external rewarming device 3, Active external rewarming device 4.
- Who it may be relevant to
- Registry conditions: Accidental Hypothermia. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Active external rewarming device
Electrical heating blanket - Device Active external rewarming device 2
Electrical heating blanket - Device Active external rewarming device 3
Electric heating blanket - Device Active external rewarming device 4
Electric heating blanket
Primary outcome measures
- Esophageal temperature rewarming rate [Time frame: 1 hour]
Eligibility criteria
Inclusion criteria
- Healthy
Exclusion criteria
- Normal BMI
- Smoking
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Norway · 1 center
- Haukeland University Hospital — Bergen
Identifiers
NCT: NCT06855173 · 2025/855256