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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypothermia, Accidental
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sigurd Mydske, PhD student; Phone Number: +4790659586; Email: sigurd.mydske@norskluftambulanse.no
• Study Contact Backup: Name: Øyvind Thomassen, PhD; Phone Number: +4797718721; Email: oyvind.thomassen1@helse-bergen.no

Study Locations

• Norway
  • Bergen, Norway
    • Recruiting
    • Haukeland University Hospital
    • Contact: Hanne Klausen, PhD; Phone Number: +4791132092; Email: hanne.klausen@helse-bergen.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy volunteers

Exclusion Criteria:

• any cronic sickness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; wrapping the participants in a vapor barrier as the inner layer (intervention),	Device: Vapor barrier; Vapor barrier
No Intervention: No intervention; without the vapor barrier to serve as a negative control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Skin temperature	45 minutes

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Investigators: Study Director: Torbjørn Nedrebø, PhD, Research Director

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2023
• Primary Completion (Anticipated): March 17, 2023
• Study Completion (Anticipated): March 15, 2024

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: March 10, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 10, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: 566433

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No