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
About this trial
This is an interventional treatment trial for Accidental Hypothermia focused on measuring Accidental hypothermia, Mountain Medicine
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
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
NCT ID
NCT05996757
First Posted
August 10, 2023
Last Updated
August 10, 2023
Sponsor
Haukeland University Hospital
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
Learn more about this trial
Effect of Wet Clothing Removal Compared to Use of a Vapor Barrier in Accidental Hypothermia
We'll reach out to this number within 24 hrs