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

Haukeland University Hospital

Status: Invitation-only

Conditions: Accidental Hypothermia

Treatments: Device: Active external rewarming device 4; Device: Active external rewarming device 3; Device: Active external rewarming device; Device: Active external rewarming device 2

Study type: Interventional

Funder types: Other

Identifiers

NCT06855173

2025/855256

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy

Exclusion criteria

• Normal BMI
• Smoking

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 3 patient groups

One active external rewarming device

Experimental group

Description:

Participants in this group will recieve one active external rewarming device

Treatment:

Device: Active external rewarming device

Two active external rewarming devices

Experimental group

Description:

Participants in this group will recieve two active external rewarming devices

Treatment:

Device: Active external rewarming device 2

Device: Active external rewarming device

Four active external rewarming devices

Experimental group

Description:

Participants in this group will recieve four active external rewarming devices

Treatment:

Device: Active external rewarming device 2

Device: Active external rewarming device

Device: Active external rewarming device 3

Device: Active external rewarming device 4