Healthy Volunteers
Conditions
Keywords
Body temperature, Healthy volunteers, EasyWarm
Brief summary
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
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.
Interventions
DEVICEBARRIER EasyWarm
Application of BARRIER EasyWarm for 10 hours. The treatment with the investigational device will be according to the instruction stated on the investigational device.
Sponsors
Molnlycke Health Care AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Provision of informed consent 2. Adult males and females ≥ 18 years old 3. Able to maintain a supine position up to 10 hours.
Exclusion criteria
1. 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. 2. Impaired circulation/vascular disease 3. Impaired sensitivity/neuropathy 4. Active skin disease 5. Female with temperature variations due to menopause 6. Pregnancy or lactation at time of study participation. 7. Person not suitable for the investigation according to the clinician's judgement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin temperature | 10 hours | Relative change in average skin temperature (ºC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin temperature 2 | 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and10 hours | 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. |
| Skin temperature 3 | 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours | 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. |
| Skin temperature 1 | 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 hours | 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. |
| Body Core temperature 2 | 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours | 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. |
| Heat perception | 30 minutes, 5 hours and 10 hours | 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. |
| Body Core Temperature 1 | 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours | 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. |
Countries
Sweden
Outcome results
None listed