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Active External Rewarming from Accidental Hypothermia - a Dose-response Pilot Study

Active External Rewarming from Accidental Hypothermia - a Dose-response Pilot Study

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06855173
Enrollment
12
Registered
2025-03-03
Start date
2025-03-11
Completion date
2025-03-12
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accidental Hypothermia

Keywords

hypothermia, active external rewarming

Brief 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. 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

DEVICEActive external rewarming device

Electrical heating blanket

DEVICEActive external rewarming device 2

Electrical heating blanket

DEVICEActive external rewarming device 3

Electric heating blanket

DEVICEActive external rewarming device 4

Electric heating blanket

Sponsors

Haukeland University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy

Exclusion criteria

* Normal BMI * Smoking

Design outcomes

Primary

MeasureTime frameDescription
Esophageal temperature rewarming rate1 hourDevelopement of esophageal temperature during the rewarming phase after cooling. Participants will be shiver-inhibited in this phase of the trial

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026