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

February 25, 2025 updated by: Haukeland University Hospital
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5009
        • Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy

Exclusion Criteria:

  • Normal BMI
  • Smoking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: One active external rewarming device
Participants in this group will recieve one active external rewarming device
Device: Active external rewarming device
Electrical heating blanket
Experimental: Two active external rewarming devices
Participants in this group will recieve two active external rewarming devices
Device: Active external rewarming device
Electrical heating blanket
Device: Active external rewarming device 2
Electrical heating blanket
Experimental: Four active external rewarming devices
Participants in this group will recieve four active external rewarming devices
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Investigators

  • Study Director: Øyvind Thomassen, MD, PhD, Haukeland University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 11, 2025

Primary Completion (Estimated)

March 12, 2025

Study Completion (Estimated)

March 12, 2025

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/855256

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Risk of identifiable data due to a low number of participants

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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