Skin Tone Measurement Method Investigation for Pulse Oximetry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Preferred skin PMM in the context of pulse-oximetry.
研究概览
简要总结
The primary objective is to gather missing information in order to form a well-founded recommendation on which is the preferred skin pigmentation measurement (PPM) methods in the context of pulse-oximetry.
详细描述
Skin tone bias in pulse-oximetry (SpO2) needs to be addressed urgently. While skin pigmentation is a prime candidate for the root cause of skin tone bias in SpO2, more research is needed. F A solid comparison and recommendation requires evaluation of several additional aspects that affect accuracy, precision, and reproducibility of the PMMs.
Briefly, these additional aspects that are evaluated in this study are listed below:
- operator bias
- impact of operator color blindness
- probe pressure
- probe aperture size
- device stability
- impact of blood on pigmentation measurement
- feasibility of skin tone measurement on sides of fingers
- intra-operator variability
PMMs included in this study are:
Subjective color matching methods by using:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18-65 years)
- •Fluent in either English or Dutch
- •Participants who are willing and able to provide informed consent themselves.
- •People with Von Luschan scores <18 ('light skin' group) or > 25 ('dark skin' group).
排除标准
- •Skin conditions that could potentially interfere with the measurements:
- •piercings/ink/henna tattoos that cover the left forearm, hands, fingers or forehead
- •vascular or pigmentary or renal psoriasis
- •epidermal bullosum
- •other diseases that affect the skin (tone) of the body
- •COVID-19 exclusion criteria*:
- •Currently displaying COVID-19-related symptoms, namely a fever, cough and/or difficulty breathing
- •Having been positively tested as infected with COVID-19 in the past 14 days
- •Travelled to or from high risk COVID-19 areas in the past 14 days
- •Been in contact with a (suspected) COVID-infected person in the past 14 days
- •Not being able to travel to Eindhoven 3 times, and/or not being able to comply with the study procedures
- •Sunbathing during the study duration or substantial sun exposure (due to holidays for example).
- •Known allergic reaction to facial make-up
- •Usage of tanning sprays/cremes
- •Wearing make-up during the study visits (mascara is allowed)
- •No testing will be performed in the study. Participants will be asked if they have been positively tested.
结局指标
主要结局
Preferred skin PMM in the context of pulse-oximetry.
时间窗: 10 months
The primary objective is to complement a previous skin pigmentation study executed by Philips to gather missing information in order to form a well-founded recommendation on which is the preferred skin PPM in the context of pulse-oximetry.
次要结局
未报告次要终点