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

NCT05779722 | Unknown

• 1 other identifier: 566433
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia, Accidental

Outcome Measures

Primary Outcomes (1)

• Skin temperature

  45 minutes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Device: Vapor barrier

No intervention

NO INTERVENTION

without the vapor barrier to serve as a negative control

Interventions

Vapor barrier DEVICE

Vapor barrier

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy volunteers

You may not qualify if:

• any cronic sickness

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, Norway

RECRUITING

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: 38664809 DERIVED

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Torbjørn Nedrebø, PhD

  Research director

  STUDY DIRECTOR

Central Study Contacts

Sigurd Mydske, PhD student

CONTACT

+4790659586; sigurd.mydske@norskluftambulanse.no

Øyvind Thomassen, PhD

CONTACT

+4797718721; oyvind.thomassen1@helse-bergen.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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. 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. They will stay in this position for 45 minutes to allow for a drop in the skin temperature without a drop in core body temperature. After 45 minutes, the research participant will be randomised into one of two scenarios, intervention or control.

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 22, 2023
• Study Start: March 8, 2023
• Primary Completion: March 17, 2023
• Study Completion: March 15, 2024
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)