The Effect of a Vapor Barrier in Combination With Active External Rewarming for Patients With Accidental Hypothermia
Primary Purpose
Hypothermia, Accidental
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Vapor barrier
Sponsored by
About this trial
This is an interventional treatment trial for Hypothermia, Accidental
Eligibility Criteria
Inclusion Criteria: healthy volunteers Exclusion Criteria: any cronic sickness
Sites / Locations
- Haukeland University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
No intervention
Arm Description
wrapping the participants in a vapor barrier as the inner layer (intervention),
without the vapor barrier to serve as a negative control
Outcomes
Primary Outcome Measures
Skin temperature
Secondary Outcome Measures
Full Information
NCT ID
NCT05779722
First Posted
March 10, 2023
Last Updated
March 10, 2023
Sponsor
Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05779722
Brief Title
The Effect of a Vapor Barrier in Combination With Active External Rewarming for Patients With Accidental Hypothermia
Official Title
The Effect of a Vapor Barrier in Combination With Active External Rewarming for Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2023 (Actual)
Primary Completion Date
March 17, 2023 (Anticipated)
Study Completion Date
March 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia, Accidental
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
wrapping the participants in a vapor barrier as the inner layer (intervention),
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
without the vapor barrier to serve as a negative control
Intervention Type
Device
Intervention Name(s)
Vapor barrier
Intervention Description
Vapor barrier
Primary Outcome Measure Information:
Title
Skin temperature
Time Frame
45 minutes
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy volunteers
Exclusion Criteria:
any cronic sickness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sigurd Mydske, PhD student
Phone
+4790659586
Email
sigurd.mydske@norskluftambulanse.no
First Name & Middle Initial & Last Name or Official Title & Degree
Øyvind Thomassen, PhD
Phone
+4797718721
Email
oyvind.thomassen1@helse-bergen.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torbjørn Nedrebø, PhD
Organizational Affiliation
Research director
Official's Role
Study Director
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanne Klausen, PhD
Phone
+4791132092
Email
hanne.klausen@helse-bergen.no
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of a Vapor Barrier in Combination With Active External Rewarming for Patients With Accidental Hypothermia
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