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

Primary Purpose

Accidental Hypothermia, Emergencies

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Wet clothing removal
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Accidental Hypothermia focused on measuring Accidental hypothermia, Mountain Medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age <18 American Society of Anaesthesiologists class 1 No nicotine use Exclusion Criteria: Acute illness on study day, fever or malaise

Sites / Locations

  • Haukeland University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Wet clothing removal

Vapor barrier

Arm Description

Outcomes

Primary Outcome Measures

Mean skin temperature
Change in mean skin temperature during rewarming phase

Secondary Outcome Measures

Subjective thermal comfort and shivering
Using a validated questionnaire at regular intervals

Full Information

First Posted
August 10, 2023
Last Updated
August 10, 2023
Sponsor
Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05996757
Brief Title
Effect of Wet Clothing Removal Compared to Use of a Vapor Barrier in Accidental Hypothermia
Official Title
Effect of Wet Clothing Removal in the Treatment of Accidental Hypothermia: A Human Crossover Field Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
March 21, 2017 (Actual)
Study Completion Date
March 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accidental Hypothermia, Emergencies
Keywords
Accidental hypothermia, Mountain Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wet clothing removal
Arm Type
Active Comparator
Arm Title
Vapor barrier
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Wet clothing removal
Intervention Description
The participants in the intervention group will have their clothing removed prior to insulation.
Primary Outcome Measure Information:
Title
Mean skin temperature
Description
Change in mean skin temperature during rewarming phase
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Subjective thermal comfort and shivering
Description
Using a validated questionnaire at regular intervals
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age <18 American Society of Anaesthesiologists class 1 No nicotine use Exclusion Criteria: Acute illness on study day, fever or malaise
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Øyvind Thomassen, MD, PhD
Organizational Affiliation
Haukeland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25712295
Citation
Henriksson O, Lundgren PJ, Kuklane K, Holmer I, Giesbrecht GG, Naredi P, Bjornstig U. Protection against cold in prehospital care: wet clothing removal or addition of a vapor barrier. Wilderness Environ Med. 2015 Mar;26(1):11-20. doi: 10.1016/j.wem.2014.07.001.
Results Reference
result

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

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