NCT07450092

Brief Summary

Forced air warming may be a feasible strategy for prehospital rewarming of patients with accidental hypothermia. This pilot study will explore the feasibility of this technique which has not been studied outside of hospital.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2026

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 23, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

March 10, 2026

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2026

Completed
Last Updated

March 4, 2026

Status Verified

February 1, 2026

Enrollment Period

1 day

First QC Date

February 23, 2026

Last Update Submit

February 27, 2026

Conditions

Hypothermia Due to Cold Environment

Keywords

hypothermiaaccidental hypothermiamountain medicine

Outcome Measures

Primary Outcomes (1)

  • Esophageal temperature

    Changes in body temperature of participants measured in the esophagus

    1 hour

Secondary Outcomes (6)

  • Feasibility of the experimental procedure

    3 hours

  • Air temperature

    1 hour

  • Air velocity

    1 hour

  • Air particle concentration

    1 hour

  • Subjective comfort

    3 hours

  • +1 more secondary outcomes

Study Arms (1)

Forced air warming group

EXPERIMENTAL

All participants.

Device: Forced air warming

Interventions

Forced air warmingDEVICE

Prehospital use of forced air warming

Forced air warming group

Eligibility Criteria

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

You may qualify if:

  • Age: Participant must be over 18 and under 45 years of age at the time of signing the informed consent.
  • Type of Participant and Disease Characteristics: Participants who are overtly healthy as determined by their medical history. The participants will be asked to fill out a health report stating to be healthy, using no relevant medication, and having no relevant allergies or hypersensitivity to the active substances or to any of the excipients of the medications used.
  • Weight: BMI under 30 kg/m2
  • Sex and Contraceptive/Barrier Requirements: Both male and female participants can be included. Female participants of childbearing potential will be asked to take a pregnancy test to confirm the absence of pregnancy prior to study drug administration on both visit 1 and 2.
  • Informed Consent: Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

You may not qualify if:

  • Drugs: Concomitant use of sedatives, MAO-inhibitors, SSRI, ritonavir, cimetidine, chlorpromazine, phenytoin, erythromycin, itraconazole, platelet inhibitors, Apomorphine, alcohol (during the trial period) or other opioids or opioid antagonists (during the trial period).
  • History of drug dependency: Recent head injury (last. 12 months), known increased ICP, seizures or epilepsy
  • Other: Known reduced liver- or kidney function, reduced respiratory drive, known supraventricular tachycardia or prolonged QTc, hypertrophy of the prostate or urinary constriction, ongoing pregnancy or breastfeeding. Known acute glaucoma, myasthenia gravis. History of cold injuries or frostbites.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, 5022, Norway

Location

Related Publications (1)

  • Mydske S, Brattebo G, Osteras O, Wiggen O, Assmus J, Thomassen O. Effect of a vapor barrier in combination with active external rewarming for cold-stressed patients in a prehospital setting: a randomized, crossover field study. Scand J Trauma Resusc Emerg Med. 2024 Apr 25;32(1):35. doi: 10.1186/s13049-024-01204-2.

    PMID: 38664809BACKGROUND

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Pilot study to investigate feasibility
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2026

First Posted

March 4, 2026

Study Start

March 10, 2026

Primary Completion

March 11, 2026

Study Completion

March 11, 2026

Last Updated

March 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

GDPR

Locations

NO(1)