Accidental HypothermiaNCT05996757
Effect of Wet Clothing Removal Compared to Use of a Vapor Barrier in Accidental Hypothermia
A study testing Wet clothing removal in people with Accidental Hypothermia and Emergencies, run by Haukeland University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Hypothermia, Emergencies
- What is being tested?
- Wet clothing removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNorway
- Study dates
- 20 Mar 2017to 21 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age <18
- American Society of Anaesthesiologists class 1
- No nicotine use
Who cannot join
- Acute illness on study day, fever or malaise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Wet Clothing Removal in the Treatment of Accidental Hypothermia: A Human Crossover Field Study
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.
- Conditions
- Accidental Hypothermia, Emergencies
- Being tested
- Wet clothing removal
- Keywords
- Accidental hypothermia, Mountain Medicine
- Medical subject headings
- Hypothermia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wet clothing removalProcedure or surgery
The participants in the intervention group will have their clothing removed prior to insulation.
| Study group | Role | What they receive |
|---|---|---|
| Wet clothing removal | Active comparator | Not described Receives: Procedure: Wet clothing removal |
| Vapor barrier | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean skin temperature
Change in mean skin temperature during rewarming phase
Measured: 60 minutes
Secondary outcomes (1)
Subjective thermal comfort and shivering
Using a validated questionnaire at regular intervals
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start20 Mar 2017
- Primary completion21 Mar 2017
- Study completion21 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Accidental HypothermiaStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Øyvind Thomassen, MD, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996757
- Sponsor's protocol ID
- 2017/150
- Status last verified
- Aug 2023
- First submitted
- 10 Aug 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 25712295Hagen 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.
PubMed 38273259
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Wet Clothing Removal in the Treatment of Accidental Hypothermia: A Human Crossover Field Study
- ClinicalTrials.gov ID
- NCT05996757
- Acronym / sponsor ID
- 2017/150
- Conditions
- Accidental Hypothermia, Emergencies
- Keywords
- Accidental hypothermia, Mountain Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 21 Mar 2017 (actual)
- Study completion
- 21 Mar 2017 (actual)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wet clothing removal | Active comparator | Procedure: Wet clothing removal |
| Vapor barrier | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age <18
- American Society of Anaesthesiologists class 1
- No nicotine use
Key exclusion criteria (1 listed)
- Acute illness on study day, fever or malaise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wet clothing removalThe participants in the intervention group will have their clothing removed prior to insulation. | Procedure or surgery | Wet clothing removal |
Primary outcome
Mean skin temperature
Time frame: 60 minutes
Change in mean skin temperature during rewarming phase
1 secondary outcome
Subjective thermal comfort and shivering
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Results publication: PubMed 25712295Henriksson 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.
- Derived from this study: PubMed 38273259Hagen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Øyvind Thomassen, MD, PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wet clothing removal in people with Accidental Hypothermia and Emergencies, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean skin temperature (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05996757, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.