Portrait Mobile Monitoring Solution V2.0 External Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Collection of user feedback surveys from Clinicians
研究概览
简要总结
The purpose of this study is to collect and assess feedback from the users regarding the functionality and performance of the Portrait Mobile Monitoring Solution V2.0. In addition, this study aims to collect raw parameter data from the investigational devices for use in current and future Portrait Mobile development, including engineering purposes as deemed appropriate by the Sponsor.
详细描述
Subjects will be enrolled from a general hospital ward to receive continuous monitoring for up to 72 hours by the Portrait Mobile Monitoring Solution V2.0. After the completion of that monitoring, both the clinician and the subject will complete a feedback survey about their experience with the device. The surveys along with raw data from the device will be collected from each subject.
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
- 否
入选标准
- •Participant is age 18 years or older (≥18 years).
- •Participant must have the ability to understand and 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.
- •Participant must be willing and able to comply with study procedures and duration.
排除标准
- •Known to be pregnant and/or breast feeding.
- •Diagnosed with infection requiring isolation.
- •Are immunocompromised.
- •Have previously participated in this study (no subject may participate more than once).
- •Subjects with Implantable Minute Ventilation Rate Responsive Pacemakers should be excluded from respiration rate monitoring.
研究组 & 干预措施
Continuous Monitoring with Portrait Mobile
Subjects will be monitored with the Portrait Mobile Monitoring Solution for up to 72 hours
干预措施: Continuous Monitoring (Device)
结局指标
主要结局
Collection of user feedback surveys from Clinicians
时间窗: Up to 72 hours
Number of clinician feedback surveys collected at the end of each shift for clinicians overseeing care of subjects receiving continuous vital signs monitoring.
Collection of Subject Survey
时间窗: up to 72 hours
Number of subject surveys collected from study participants at the end of their continuous monitoring
次要结局
- Collection of raw parameter data from Portrait Mobile Device(up to 72 hours)