An interventional study of Active external rewarming device and Active external rewarming device 2 in Accidental Hypothermia, sponsored by Haukeland University Hospital. Enrolling by invitation at 1 site in Norway. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-03.
Sponsored by Haukeland University Hospital · Not applicable, Interventional, and Treatment
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.
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.
449 studies on the registry are indexed under Hypothermia; 54 are open to participants now.
This study's planned enrollment of 12 is below the median of 77 across 328 interventional studies indexed under Hypothermia.
Browse Hypothermia studies →Haukeland University Hospital is the lead sponsor of 284 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will recieve one active external rewarming device
Device: Active external rewarming device
Participants in this group will recieve two active external rewarming devices
Device: Active external rewarming device · Device: Active external rewarming device 2
Participants in this group will recieve four active external rewarming devices
Device: Active external rewarming device · Device: Active external rewarming device 2 · Device: Active external rewarming device 3 · Device: Active external rewarming device 4
Electrical heating blanket
Electrical heating blanket
Electric heating blanket
Electric heating blanket
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
Time frame: 1 hour
Plan to share: Undecided — Risk of identifiable data due to a low number of participants
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