NCT06855173

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

March 11, 2025

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2025

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

1 day

First QC Date

February 25, 2025

Last Update Submit

February 25, 2025

Conditions

Accidental Hypothermia

Keywords

hypothermiaactive external rewarming

Outcome Measures

Primary Outcomes (1)

  • 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

    1 hour

Study Arms (3)

One active external rewarming device

EXPERIMENTAL

Participants in this group will recieve one active external rewarming device

Device: Active external rewarming device

Two active external rewarming devices

EXPERIMENTAL

Participants in this group will recieve two active external rewarming devices

Device: Active external rewarming deviceDevice: Active external rewarming device 2

Four active external rewarming devices

EXPERIMENTAL

Participants in this group will recieve four active external rewarming devices

Device: Active external rewarming deviceDevice: Active external rewarming device 2Device: Active external rewarming device 3Device: Active external rewarming device 4

Interventions

Active external rewarming deviceDEVICE

Electrical heating blanket

Four active external rewarming devicesOne active external rewarming deviceTwo active external rewarming devices
Active external rewarming device 2DEVICE

Electrical heating blanket

Four active external rewarming devicesTwo active external rewarming devices
Active external rewarming device 3DEVICE

Electric heating blanket

Four active external rewarming devices
Active external rewarming device 4DEVICE

Electric heating blanket

Four active external rewarming devices

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy

You may not qualify if:

  • Normal BMI
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, Bergen, 5009, Norway

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Øyvind Thomassen, MD, PhD

    Haukeland University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 3, 2025

Study Start

March 11, 2025

Primary Completion

March 12, 2025

Study Completion

March 12, 2025

Last Updated

March 3, 2025

Record last verified: 2025-02

Locations

NO(1)