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CompletedNCT05996757Updated Aug 18, 2023

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

An interventional study of Wet clothing removal in Accidental Hypothermia and Emergencies, sponsored by Haukeland University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-18.

Sponsored by Haukeland University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 years 4 months after the study started (first participant enrolled Mar 2017, registered Aug 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Accidental Hypothermia
  • Emergencies

Keywords

  • Accidental hypothermia
  • Mountain Medicine
03

In context

Emergencies

1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.

This study's enrollment of 8 is below the median of 145 across 931 interventional studies indexed under Emergencies.

Browse Emergencies studies →

Lead sponsor

Haukeland University Hospital is the lead sponsor of 276 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Acute illness on study day, fever or malaise
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
8 participants (actual)

Study arms

  • Active comparator
    Wet clothing removal

    Procedure: Wet clothing removal

  • No intervention
    Vapor barrier

Interventions

  • ProcedureWet clothing removal

    The participants in the intervention group will have their clothing removed prior to insulation.

06

What researchers measure

Primary outcomes

  1. Mean skin temperature

    Change in mean skin temperature during rewarming phase

    Time frame: 60 minutes

Secondary outcomes

  1. Subjective thermal comfort and shivering

    Using a validated questionnaire at regular intervals

    Time frame: 60 minutes

07

Study locations

1 site
  • Haukeland University Hospital
    Bergen, Norway
08

References and documents

Publications

  • 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. PubMed 25712295 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05996757
Lead sponsor
Haukeland University Hospital
Responsible party
Sponsor
First posted
Aug 18, 2023
Start date
Mar 20, 2017
Primary completion
Mar 21, 2017
Completion
Mar 21, 2017
Last update
Aug 18, 2023

Study contacts

Øyvind Thomassen, MD, PhD
principal investigator · Haukeland University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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