Data Collection Study for RFP (Respiration From Plethysmogram)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Data collection for database for algorithm development
研究概览
简要总结
The study will be conducted in hospitalised patients who undergo spot-check monitoring of vital signs as part of their routine care.
详细描述
In an additional spot-check measurement procedure, the study will measure oxygen saturations through different Philips SpO2 finger sensors. Patients will wear a nasal cannula linked to a CO2 measuring device at the same time. The data from both devices will be used to design and improve algorithms for measurement of respiratory rate with the saturation probe and the Philips FAST pulse oximeter system. The study will include 50 adult patients and 25 pediatric patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects (aged 18 years or older) willing and able to understand and provide written informed consent
- •Paediatric subjects aged 16 years and older willing and able to understand and provide written informed consent
- •Paediatric subjects aged approx. 4-16 years and their legal guardians, willing and able to understand and provide written informed consent/assent
- •Subject weight within intended use of at least one SpO2 sensor under test at time of enrolment (M1191T: adult patients >50kg, M1196T: adult patients >40kg, M1192A: paediatric patients 15-50kg)
- •Willing and able to wear study devices during study procedures
- •Subject undergoing regular spot-check measurements as per the site's standard of care
排除标准
- •Palliative patients
- •Critically ill patients with severe physiological instability (NEWS ≥9)
- •Injury/wounds or physical malformation of sensor application site (i.e. fingers, toes, hands, feet)
- •Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors (self-reported)
- •Unwillingness or inability to remove coloured nail polish or artificial nails from application site
- •Nail fungus on application site
- •Severe dermatitis or hyperkeratosis (e.g. ichthyosis) at sensor application site
研究组 & 干预措施
In-patients with routine spot-check monitoring of vital signs
In-patients with routine spot-check monitoring of vital signs
干预措施: spot-check measurement (Device)
结局指标
主要结局
Data collection for database for algorithm development
时间窗: 6 months
Anonymized database of subject data from the Oxygen Saturation finger sensors (photoplethysmogram waveform) and the reference sensors (capnography waveform)
次要结局
未报告次要终点