Vital Signs Camera Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Clinical safety and effectiveness VSC-MEDlib according to IFU
研究概览
简要总结
This study is a single center, prospective clinical investigation which is balanced for gender, age, Body Mass Index (BMI) and skin color. Simultaneous measurements of PR and RR on study participants will be collected in conditions described in IFU and various suboptimal conditions. The study participants will be recorded with the VSC demo app (together with a compatible camera and computing hardware) and reference devices. PR and RR data to be collected by the VSC demo app, will be post-processed after the clinical investigation and compared with the reference devices. Persons who are willing to participate will be asked to provide their consent.
Primary objective:
• To assess the clinical safety and effectiveness of Pulse Rate (PR) and Respiration Rate (RR) measured with the VSC-MEDlib within the intended use compared to the gold-standard reference devices.
Exploratory objective:
• To assess the clinical safety and effectiveness of Pulse Rate and Respiration Rate measured with the VSC-MEDlib during suboptimal circumstances (outside the scope of the intended use), compared to the gold-standard reference devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Persons with ASA I or II classification
- •Adult population (age >18 years old)
- •BMI ≥ 18 - ≤ 40 kg/m2
- •Able to intensively exercise for 10 minutes
- •Persons willing to give informed consent
- •Willingness to have vital signs measured by a medical mobile application
- •Willingness to follow study protocol (e.g., put on sunglasses, facial make-up, medical face-mask and sitting still up to 2 minutes)
排除标准
- •Vulnerable populations (e.g., age <18 years old, not able to consent by themselves, or immunecompromised or pregnant women)
- •Cardiac arrhythmias (e.g., Atrial Fibrillation, Supraventricular Tachycardia, Ventricular arrhythmia, regular ectopic beats)
- •Persons present signs of infection
- •Participant has known allergic reactions to make-up and/or make-up remover
- •Persons with positive COVID 19 test in last 14 days
- •Participant who exhibit irregular or excessive movement such as tremors, tics, shaking and/or shivering
- •Participant is Philips employee or their family members residing with this Philips employee.
结局指标
主要结局
Clinical safety and effectiveness VSC-MEDlib according to IFU
时间窗: 2 hours
Clinical safety and effectiveness of the non-invasive and contactless measurement RR by the VSC-MEDlib within the intended use.
次要结局
未报告次要终点