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Enrolling by Invitation

NCT Number: NCT06855173

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

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.

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Key information

Conditions

Accidental Hypothermia Body Temperature Changes Hypothermia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital

Bergen, 5009, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy

Exclusion criteria

  • Normal BMI
  • Smoking

Treatment and study plan

Active external rewarming device

Device

Electrical heating blanket

Active external rewarming device 2

Device

Electrical heating blanket

Active external rewarming device 3

Device

Electric heating blanket

Active external rewarming device 4

Device

Electric heating blanket

Primary outcomes

  1. Esophageal temperature rewarming rate

    Time frame: 1 hour

    Developement of esophageal temperature during the rewarming phase after cooling. Participants will be shiver-inhibited in this phase of the trial

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 3, 2025
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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