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

• Sponsor: Haukeland University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05996757
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arms: 2
• Actual Duration (Days): 1
• Patients Per Site Per Month: 243.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Accidental Hypothermia; Emergencies	Procedure: Wet clothing removal	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Effect of Wet Clothing Removal in the Treatment of Accidental Hypothermia: A Human Crossover Field Study
• Actual Study Start Date: Mar 20, 2017
• Actual Primary Completion Date: Mar 21, 2017
• Actual Study Completion Date: Mar 21, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Mean skin temperature [60 minutes]

   Change in mean skin temperature during rewarming phase

Secondary Outcome Measures

1. Subjective thermal comfort and shivering [60 minutes]

   Using a validated questionnaire at regular intervals

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age <18

• American Society of Anaesthesiologists class 1

• No nicotine use

Exclusion Criteria:

• Acute illness on study day, fever or malaise

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Haukeland University Hospital	Bergen		Norway

Sponsors and Collaborators

• Haukeland University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Haukeland University Hospital
• ClinicalTrials.gov Identifier: NCT05996757
• Other Study ID Numbers: 2017/150
• First Posted: Aug 18, 2023
• Last Update Posted: Aug 18, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Haukeland University Hospital: Accidental hypothermia; Mountain Medicine
• Additional relevant MeSH terms: Emergencies; Hypothermia

Study Results

No Results Posted as of Aug 18, 2023