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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Skin temperature
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of informed consent
- •Adult males and females ≥ 18 years old
- •Able to maintain a supine position up to 10 hours.
排除标准
- •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.
结局指标
主要结局
Skin temperature
时间窗: 10 hours
Relative change in average skin temperature (ºC)
次要结局
- Skin temperature 2(30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and10 hours)
- Skin temperature 1(30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 hours)
- Skin temperature 3(30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours)
- Body Core Temperature 1(30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours)
- Body Core temperature 2(30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours)
- Heat perception(30 minutes, 5 hours and 10 hours)