Feasibility Study Of Ambulatory Monitoring System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- User feedback
研究概览
简要总结
This is a clinical, data collection study conducted at one site. This study will collect open comments, user feedback and parameter raw data to support patient monitoring product development. Subjects participating in this study will be monitored with the site's standard of care primary monitor and the investigational device as the secondary monitor while enrolled in this study. No subject care decisions or diagnoses will be made based on information obtained from the investigational secondary monitor.
详细描述
This is a pre-market, open label, prospective, non-randomized, data collection clinical research study conducted at one investigational site. This study will collect open comments, user feedback and parameter raw data to support product development. Raw parameter data will be collected from electrocardiogram (ECG), Pulse Rate (PR), respiratory rate (RR), peripheral capillary oxygen saturation (SpO2), non-invasive blood pressure (NIBP), and temperature. Subjects participating in this study will be monitored with the site's standard of care primary monitor and the investigational device as the secondary monitor while enrolled in this study. No subject care decisions or diagnoses will be made based on information obtained from the investigational secondary monitor.
Participation is expected to last no more than 72 hours.
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
- 0 Days 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are able to provide written informed consent or have a legally designated representative provide written informed consent;
- •Are being cared for in a hospital unit and are expected to remain in the unit for the duration of the study procedure; AND
- •Are an adult 18 years or older, or pediatric or neonate subject.
排除标准
- •Are known to be pregnant;
- •Are breastfeeding; OR
- •Are suffering from infections that require isolation.
结局指标
主要结局
User feedback
时间窗: through study completion, average of one day per subject
This is an early feasibility study intended to elicit user feedback in a hospital setting in order to improve device functionality and further development of the measurement algorithms. User feedback will be collected by open comments field in CRF.
Collection of electronic parameter data
时间窗: 2 hours up to 3 days
Electronic device files from patient sensors will be collected for each subject.
次要结局
- Safety information(through study completion and issues resolved, average of one day per subject)