NCT05996757

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2017

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2017

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

1 day

First QC Date

August 10, 2023

Last Update Submit

August 10, 2023

Conditions

Keywords

Accidental hypothermiaMountain Medicine

Outcome Measures

Primary Outcomes (1)

  • Mean skin temperature

    Change in mean skin temperature during rewarming phase

    60 minutes

Secondary Outcomes (1)

  • Subjective thermal comfort and shivering

    60 minutes

Study Arms (2)

Wet clothing removal

ACTIVE COMPARATOR
Procedure: Wet clothing removal

Vapor barrier

NO INTERVENTION

Interventions

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

Wet clothing removal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Acute illness on study day, fever or malaise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, Norway

Location

Related Publications (2)

  • 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.

  • Hagen LT, Brattebo G, Dipl-Math JA, Wiggen O, Osteras O, Mydske S, Thomassen O. Effect of wet clothing removal on skin temperature in subjects exposed to cold and wrapped in a vapor barrier: a human, randomized, crossover field study. BMC Emerg Med. 2024 Jan 25;24(1):18. doi: 10.1186/s12873-024-00937-8.

MeSH Terms

Conditions

HypothermiaEmergencies

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Øyvind Thomassen, MD, PhD

    Haukeland University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2023

First Posted

August 18, 2023

Study Start

March 20, 2017

Primary Completion

March 21, 2017

Study Completion

March 21, 2017

Last Updated

August 18, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations