NCT06855173

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Accidental Hypothermia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-03-11
• Primary completion: 2025-03-12
• Completion: 2025-03-12
• First posted: 2025-03-03
• Last updated: 2025-03-03

Locations

1 site across 1 country: Norway