A Clinical Investigation With BARRIER® EasyWarm®

Study Overview
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Brief Summary
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This investigation is a prospective, open, non-comparative, single-center investigation with the aim to investigate the effect of BARRIER EasyWarm active self-warming blanket on skin- and body core temperatures. The investigation will enroll approximately 20 healthy volunteers in one investigation site and each subject will be evaluated for up to 10 hours in one visit.

Detailed Description
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This investigation is a prospective, open, non-comparative, single-center investigation with the aim to investigate the effect of BARRIER EasyWarm active self-warming blanket on skin- and body core temperatures. The investigation will enroll approximately 20 healthy volunteers in one investigation site. Each subject will be evaluated for up to 10 hours in one visit on site. Body core- and skin reference temperatures will be established before applying the blanket. After reference temperature assessments, the BARRIER EasyWarm is positioned on the subject with the neckline at the collarbone. Skin temperatures will be assessed with an IR camera and body core temperatures will be assessed with an ear thermometer at 30 min, 1 hour, 2, 3, 4, 5, 6, 7, 8, 9, and 10 hours post blanket application. Subject perception of heat from the blanket will be assessed at 30 minutes, 5 hours and 10 hours post blanket application by means of a five graded question.

Official Title
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A Prospective, Open, Non-comparative, Single-centre Investigation to Study the Effect of BARRIER® EasyWarm® Active Self-warming Blanket on Skin- and Body Core Temperatures in Healthy Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Device: BARRIER EasyWarm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent Adult males and females ≥ 18 years old Able to maintain a supine position up to 10 hours. Exclusion Criteria: Diseases/medical treatments that affect normal body temperature control: I. Persons who have/have had thyroid disease or who are treated with medications affecting the thyroid hormones II. Persons being treated with medication affecting normal body temperature control, based on investigator judgement. Impaired circulation/vascular disease Impaired sensitivity/neuropathy Active skin disease Female with temperature variations due to menopause Pregnancy or lactation at time of study participation. Person not suitable for the investigation according to the clinician's judgement.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BARRIER EasyWarm<br>This is an open, non randomised, single arm study | Device: BARRIER EasyWarm<br>* Application of BARRIER EasyWarm for 10 hours. The treatment with the investigational device will be according to the instruction stated on the investigational device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin temperature | Relative change in average skin temperature (ºC) | 10 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin temperature 1 | Relative change in average skin temperature at 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8 and 9 hours (ºC). Assessed with an IR camera. | 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 hours | 
| Skin temperature 2 | Maximum skin temperature at 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours (ºC). Assessed with an IR camera. | 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and10 hours | 
| Skin temperature 3 | Average skin temperature at 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours (ºC). Assessed with an IR camera. | 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours | 
| Body Core Temperature 1 | Body core temperature (ºC) at 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours. Assessed with an ear thermometer. | 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours | 
| Body Core temperature 2 | Relative change in body core temperature (ºC) at 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours compared to baseline. Assessed with an ear thermometer. | 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours | 
| Heat perception | Five-point question related to perception of heat from the BARRIER EasyWarm. Assessed at 30 minutes, 5 hours and 10 hours post application. Scale: Cold, cool, not cool or warm, warm, hot. | 30 minutes, 5 hours and 10 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Body temperature, Healthy volunteers, EasyWarm