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

Sponsor

Haukeland University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05779722

Collaborator

(none)

Enrollment

Location

Arms

12.3

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypothermia, Accidental	Device: Vapor barrier	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 8, 2023

Anticipated Primary Completion Date :

Mar 17, 2023

Anticipated Study Completion Date :

Mar 15, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Skin temperature [45 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

healthy volunteers

Exclusion Criteria:

any cronic sickness

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Haukeland University Hospital	Bergen		Norway

Sponsors and Collaborators

Haukeland University Hospital

Investigators

Study Director: Torbjørn Nedrebø, PhD, Research director

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Haukeland University Hospital

ClinicalTrials.gov Identifier:

NCT05779722

Other Study ID Numbers:

566433

First Posted:

Mar 22, 2023

Last Update Posted:

Mar 22, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypothermia

Study Results

No Results Posted as of Mar 22, 2023