NCT03122405已完成不适用
Performance Equivalence of Rainbow Acoustic Monitoring (RAM) Small Sensor and RAM Revision D Sensor
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Performance comparison of RAM sensors by ARMS calculation
研究概览
简要总结
The purpose of this study was to conduct a side by side comparison of the accuracy of respiratory rate (RR) between our investigational Rainbow Acoustic Monitoring (RAM) small sensor and the FDA-cleared RAM Revision D sensor in healthy volunteers under controlled conditions.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •Physical status of ASA I or II
- •Must be able to read and communicate in English
- •Has signed written informed consent
排除标准
- •ASA physical status of III, IV, and V
- •Subject has any medical condition which in the judgement of the investigator, renders them inappropriate for participating in this study
- •Inability to tolerate sitting still or minimal movement for at least 30 minutes
研究组 & 干预措施
Test group
Experimental
The subjects will be enrolled in the test group and will simultaneously receive both RAM sensors.
干预措施: RAM sensors (Device)
结局指标
主要结局
Performance comparison of RAM sensors by ARMS calculation
时间窗: 50 minutes
Performance comparison was determined by comparing the noninvasive respiration rate measurement of the RAM sensors and calculating the arithmetic root mean square (Arms) error value.
次要结局
未报告次要终点
研究者
研究点 (2)
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