Effect of Wet Clothing Removal Compared to Use of a Vapor Barrier in Accidental Hypothermia

August 10, 2023 updated by: Haukeland University Hospital

Effect of Wet Clothing Removal in the Treatment of Accidental Hypothermia: A Human Crossover Field Study

The optimal method of prehospital insulation and rewarming of hypothermic patients have been subject of debate, and there is a substantial lack og high-quality evidence to guide providers.

One question concerns whether or not the patients clothing should be removed prior to being wrapped in an insulating model with a vapor barrier. Evaporative heat loss is one of four mechanisms of heat loss, and preventing evaporative heat loss should be a prioritized task for providers. Removal of wet clothing usually means subjecting the patient to the environment, but will reduce the evaporative heat loss considerably. An other alternative is to encapsulate the patient in a vapor barrier. Evaporative heat loss will stop when the humidity inside the vapor barrier reaches 100%.

We aim to investigate whether it is recommended to removed wet clothing or encase the patient in a vapor barrier.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bergen, Norway
        • Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age <18
  • American Society of Anaesthesiologists class 1
  • No nicotine use

Exclusion Criteria:

  • Acute illness on study day, fever or malaise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Wet clothing removal
The participants in the intervention group will have their clothing removed prior to insulation.
No Intervention: Vapor barrier

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean skin temperature
Time Frame: 60 minutes
Change in mean skin temperature during rewarming phase
60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective thermal comfort and shivering
Time Frame: 60 minutes
Using a validated questionnaire at regular intervals
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Øyvind Thomassen, MD, PhD, Haukeland University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2017

Primary Completion (Actual)

March 21, 2017

Study Completion (Actual)

March 21, 2017

Study Registration Dates

First Submitted

August 10, 2023

First Submitted That Met QC Criteria

August 10, 2023

First Posted (Actual)

August 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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