Hypothermia, AccidentalNCT05779722
The Effect of a Vapor Barrier in Combination With Active External Rewarming for Patients With Accidental Hypothermia
A study testing Vapor barrier in people with Hypothermia, Accidental, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
Most guidelines recommend the use of a vapor barrier when wrapping and isolating hypothermic patients from the environment, and this is especially important if the patient is wearing wet clothing. The vapor barrier will contain moisture evaporated from the wet clothes of the patient and increase the humidity. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hypothermia, Accidental
- What is being tested?
- Vapor barrier
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNorway
- Study dates
- 8 Mar 2023to 15 Mar 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy volunteers
Who cannot join
- any cronic sickness
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital
Bergen
Hanne Klausen, PhD, +4791132092, hanne.klausen@helse-bergen.no
About this study
Official title: The Effect of a Vapor Barrier in Combination With Active External Rewarming for Patients
Most guidelines recommend the use of a vapor barrier when wrapping and isolating hypothermic patients from the environment, and this is especially important if the patient is wearing wet clothing. The vapor barrier will contain moisture evaporated from the wet clothes of the patient and increase the humidity. Once the humidity levels reach 100%, the evaporation and thereby the evaporative heat loss will stop. The theory is that the addition of a vapor barrier will reduce the amount of heat loss and contribute to more efficient rewarming of wet, hypothermic patients. We aim to investigate how much more efficient a wrapping model with active external rewarming is with the addition of a vapor barrier.
Read the detailed description
The study will use a crossover design on where research participants will undergo repetitions of the same scenario with different interventions in order to serve as their own control. The research participants will be healthy volunteers providing both oral and written consent.
We intend to perform the experiments in an outdoor laboratory in order to achieve the most realistic conditions possible. The experiments will be conducted in Hemsedal, Norway in our "Mountain Lab", a climate chamber built inside a snow cave.
Before the start of the experiment, the research participants will be positioned in a supine position in the snow cave on an insulated stretcher in wet clothes saturated with a standardized amount of water.
- Conditions
- Hypothermia, Accidental
- Being tested
- Vapor barrier
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vapor barrierDevice
Vapor barrier
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | wrapping the participants in a vapor barrier as the inner layer (intervention), Receives: Device: Vapor barrier |
| No intervention | No intervention | without the vapor barrier to serve as a negative control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin temperature
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start8 Mar 2023
- Primary completion17 Mar 2023 (estimated)
- Study completion15 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypothermia, AccidentalStudies 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
- Model description
- The study will use a crossover design on where research participants will undergo repetitions of the same scenario with different interventions in order to serve as their own control. We intend to perform the experiments in an outdoor laboratory in order to achieve the most realistic conditions possible. The experiments will be conducted in Hemsedal, Norway in our "Mountain Lab", a climate chamber built inside a snow cave. Before the start of the experiment, the research participants will be positioned in a supine position in the snow cave on an insulated stretcher in wet clothes saturated with a standardized amount of water. They will stay in this position for 45 minutes to allow for a drop in the skin temperature without a drop in core body temperature. After 45 minutes, the research participant will be randomised into one of two scenarios, intervention or control.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Torbjørn Nedrebø, PhD, Study director, Research director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779722
- Sponsor's protocol ID
- 566433
- Status last verified
- Mar 2023
- First submitted
- 10 Mar 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mydske S, Brattebo G, Osteras O, Wiggen O, Assmus J, Thomassen O. Effect of a vapor barrier in combination with active external rewarming for cold-stressed patients in a prehospital setting: a randomized, crossover field study. Scand J Trauma Resusc Emerg Med. 2024 Apr 25;32(1):35. doi: 10.1186/s13049-024-01204-2.
PubMed 38664809
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Vapor Barrier in Combination With Active External Rewarming for Patients
- ClinicalTrials.gov ID
- NCT05779722
- Acronym / sponsor ID
- 566433
- Conditions
- Hypothermia, Accidental
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 17 Mar 2023 (estimated)
- Study completion
- 15 Mar 2024 (estimated)
- First posted
- 22 Mar 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.
Most guidelines recommend the use of a vapor barrier when wrapping and isolating hypothermic patients from the environment, and this is especially important if the patient is wearing wet clothing. The vapor barrier will contain moisture evaporated from the wet clothes of the patient and increase the humidity. Once the humidity levels reach 100%, the evaporation and thereby the evaporative heat loss will stop. The theory is that the addition of a vapor barrier will reduce the amount of heat loss and contribute to more efficient rewarming of wet, hypothermic patients. We aim to investigate how much more efficient a wrapping model with active external rewarming is with the addition of a vapor barrier.
Detailed description
The study will use a crossover design on where research participants will undergo repetitions of the same scenario with different interventions in order to serve as their own control. The research participants will be healthy volunteers providing both oral and written consent.
We intend to perform the experiments in an outdoor laboratory in order to achieve the most realistic conditions possible. The experiments will be conducted in Hemsedal, Norway in our "Mountain Lab", a climate chamber built inside a snow cave.
Before the start of the experiment, the research participants will be positioned in a supine position in the snow cave on an insulated stretcher in wet clothes saturated with a standardized amount of water.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will use a crossover design on where research participants will undergo repetitions of the same scenario with different interventions in order to serve as their own control. We intend to perform the experiments in an outdoor laboratory in order to achieve the most realistic conditions possible. The experiments will be conducted in Hemsedal, Norway in our "Mountain Lab", a climate chamber built inside a snow cave. Before the start of the experiment, the research participants will be positioned in a supine position in the snow cave on an insulated stretcher in wet clothes saturated with a standardized amount of water. They will stay in this position for 45 minutes to allow for a drop in the skin temperature without a drop in core body temperature. After 45 minutes, the research participant will be randomised into one of two scenarios, intervention or control.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Vapor barrierwrapping the participants in a vapor barrier as the inner layer (intervention), |
| No intervention | No intervention | –without the vapor barrier to serve as a negative control |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (1 listed)
- any cronic sickness
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 |
|---|---|---|
| Vapor barrierVapor barrier | Device | Intervention |
Primary outcome
Skin temperature
Time frame: 45 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Derived from this study: PubMed 38664809Mydske S, Brattebo G, Osteras O, Wiggen O, Assmus J, Thomassen O. Effect of a vapor barrier in combination with active external rewarming for cold-stressed patients in a prehospital setting: a randomized, crossover field study. Scand J Trauma Resusc Emerg Med. 2024 Apr 25;32(1):35. doi: 10.1186/s13049-024-01204-2.
- 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.
Torbjørn Nedrebø, PhD study director
Research director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vapor barrier in people with Hypothermia, Accidental, 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 1 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: status not confirmed, as of the sponsor's last update on 22 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sigurd Mydske, PhD student (+4790659586, sigurd.mydske@norskluftambulanse.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin temperature (time frame: 45 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 NCT05779722, which also lists 1 linked publication.
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 22 Mar 2023.