Evaluation of Respiration Rate Parameters in Healthy Volunteers Using a Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor
研究概览
简要总结
The purpose of this study is to meet the respiration rate accuracy specifications for the study pulse oximeter monitoring system (study device)in a healthy volunteer population when compared to established technologies for measuring parameters related to respiration, such as Capnograph Respiration Rate (RR) (CO2).
详细描述
Volunteer subjects with no significant medical problems (see specific inclusion/exclusion criteria) over the age of 18, male and female, who provide written informed consent prior to the procedure, are not pregnant, and without any contact skin allergies to adhesives found in standard pulse oximetry sensors.
The study consists of measuring parameters related to respiration in healthy volunteers by means of the Bedside Respiratory Patient Monitoring System with RR V2.0 (Nightingale). The prototype Nightingale device and multiparameter reference devices will be attached to the subject via sensors, nasal cannulas and ECG leads and the information from all devices will be captured continuously for up to 40 minutes to allow for at least 30 minutes of artifact free data 30 minutes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Male or female subjects.
- •18 years or older.
- •Subject is willing and able to provide written consent.
排除标准
- •Subject is younger than
- •Subject is pregnant or lactating
- •Subject has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors.
- •Subject has an abnormality that may prevent proper application of the device.
- •Subject is in atrial fibrillation.
- •Subject has a documented history of frequent premature ventricular contractions (PVCs), defined as greater than 3 in 30 seconds or greater than 6 in 60 seconds
- •Subject has an implanted pacemaker.
- •Subject is unwilling or unable to sign informed consent.
结局指标
主要结局
Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor
时间窗: up to 40 minutes of continous monitoring
The software shall calculate respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference.
次要结局
- ME +/- 1 Breath Per Minute, Max-N Sensor(up to 40 minutes of continuous monitoring)