Vital Sign Monitor Device Validation - WARD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Agreement between vital sign data from novel device and golden standard
研究概览
简要总结
Aim: to assess the validity of CE/FDA approved vital sign monitor devices for clinical use in clinical setting.
Patients: up to 1000 medical and/or surgical patients will be included Intervention: Studies with various wirless or novel vital sign monitor devices control: Golden standard measurements or clinical standard devices Outcome: Agreement assessed by bias and limits of agreement between Intervention and control device.
详细描述
Aim: to assess the validity of CE/FDA approved vital sign monitor devices for clinical use in clinical setting.
Patients: up to 1000 medical and/or surgical patients will be included. Intervention: Studies with various wireless or novel vital sign monitor devices control: Golden standard measurements or clinical standard devices Outcome: Agreement assessed by bias and limits of agreement between Intervention and control device. Other statistical assessments of agreement may be chosen as secondary outcomes, dependent on the data-structure
Setting: the study will be carried out in up to 76 hours with collection of vital sign data pre-, intra or postoperatively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Agreement between vital sign data from novel device and golden standard
时间窗: 76 hours
agreement between novel device and golden standard or clinical standard devices, assess by bias and limits of agreement
次要结局
- Description of data from novel device and golden standard(76 hours)
研究者
Eske Kvanner Aasvang
Professor
Rigshospitalet, Denmark