Clinical trial NCT05779722: The Effect of a Vapor Barrier in Combination With Active External Rewarming for Patients With Accidental Hypothermia
Official title: The Effect of a Vapor Barrier in Combination With Active External Rewarming for Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypothermia, Accidental
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model 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.

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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* any cronic sickness

Primary outcomes:
measure: Skin temperature
timeFrame: 45 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Research director
name: Torbjørn Nedrebø, PhD
role: STUDY_DIRECTOR
References: