VitalThings Guardian Contactless Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Accuracy
研究概览
简要总结
This is a confirmatory study without any intervention. It is an uncontrolled, non-randomized and open-label study with measurements made with comparators, and it has a preset hypothesis for the primary endpoint. There are no similar devices to VitalThings Guardian M10 / M10 mobile on the market, consequently one or more different types of devices must be used as comparators.
详细描述
The purpose of the clinician investigation is to validate a claim made for the investigational device performance. The objective is to confirm that the device performs at +/- 1.2 respirations per minute (RPM) accuracy against the identified comparator device, and compare performance to the standard of care as documented in the literature. The study will be conducted with patients admitted to the emergency ward after the initial treatment and examination.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Adult patients admitted to the Emergency Ward (EW)
排除标准
- •Under age (below 18 years) and subjects not able to provide informed consent themselves. Subjects dismissed from the EW rooms within 30 minutes from first registration are removed from the study.
结局指标
主要结局
Accuracy
时间窗: Will be assessed after last participant has finished the investigation. One interim analysis in first week is planned.
Documented system respiration frequency in RPM for both investigational device and comparator.
次要结局
- Comparative pulse data(Will be assessed in 2024, furter details not established.)