Comfort Evaluation of Non-Invasive Respiratory Monitor Interfaces
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Comfort Rating Self-Report Instrument
研究概览
简要总结
This research study will test the comfort of two noninvasive respiratory monitoring sensors (the connection to a monitor worn by a person-not the monitor). The two sensors, Masimo Rainbow Acoustic Monitoring sensor and Oridion Smart Capnoline Plus H sensor, are cleared by the U.S. Food and Drug Administration (FDA) and currently used in the clinical setting. People who enter into the study will wear the two interfaces, one after the other, for 20 minutes each (10 minutes with a small flow of air to the nostrils and 10 minutes without) and rate the comfort of each with a seven question survey. A total of 30 participants will be recruited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal body temperature
- •Between the ages of 19-65 years
- •Self-report as feeling to be in typical health
- •No skin irritation face or neck where a sensor would be placed.
- •School of Health Professions student
排除标准
- •Any injury or condition that would affect assessment of comfort.
结局指标
主要结局
Comfort Rating Self-Report Instrument
时间窗: 5 Minutes
A seven-question written instrument constructed in the style of descriptive analogue to evaluate multiple facets of device comfort. Answer choices allow either ordinal ranking (one requires a ranking on a continuous time scale).
次要结局
未报告次要终点
研究者
Jonathan B. Waugh, PhD
Principal Investigator
University of Alabama at Birmingham