The Effect of a Vapor Barrier in Combination With Active External Rewarming for Patients With Accidental Hypothermia

NCT ID: NCT05779722

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-08
• Study Completion Date: 2024-03-15

Brief Summary

Most guidelines recommend the use of a vapor barrier when wrapping and isolating hypothermic patients from the environment, and this is especially important if the patient is wearing wet clothing. The vapor barrier will contain moisture evaporated from the wet clothes of the patient and increase the humidity. Once the humidity levels reach 100%, the evaporation and thereby the evaporative heat loss will stop. The theory is that the addition of a vapor barrier will reduce the amount of heat loss and contribute to more efficient rewarming of wet, hypothermic patients. We aim to investigate how much more efficient a wrapping model with active external rewarming is with the addition of a vapor barrier.

Detailed Description

The study will use a crossover design on where research participants will undergo repetitions of the same scenario with different interventions in order to serve as their own control. The research participants will be healthy volunteers providing both oral and written consent.

We intend to perform the experiments in an outdoor laboratory in order to achieve the most realistic conditions possible. The experiments will be conducted in Hemsedal, Norway in our "Mountain Lab", a climate chamber built inside a snow cave.

Before the start of the experiment, the research participants will be positioned in a supine position in the snow cave on an insulated stretcher in wet clothes saturated with a standardized amount of water.

Conditions

Hypothermia, Accidental

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

wrapping the participants in a vapor barrier as the inner layer (intervention),

Group Type: EXPERIMENTAL

Vapor barrier

Intervention Type: DEVICE

Vapor barrier

No intervention

without the vapor barrier to serve as a negative control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vapor barrier

Vapor barrier

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• healthy volunteers

Exclusion Criteria

• any cronic sickness

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Torbjørn Nedrebø, PhD

Role: STUDY_DIRECTOR

Research director

Locations

Haukeland University Hospital

Bergen, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Sigurd Mydske, PhD student

Role: CONTACT

sigurd.mydske@norskluftambulanse.no

+4790659586

Øyvind Thomassen, PhD

Role: CONTACT

oyvind.thomassen1@helse-bergen.no

+4797718721

Facility Contacts

Hanne Klausen, PhD

Role: primary

hanne.klausen@helse-bergen.no

+4791132092

References

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.

Reference Type: DERIVED

PMID: 38664809 (View on PubMed)

Other Identifiers

566433

Identifier Type: -

Identifier Source: org_study_id