Validating the Accuracy of the Airvo 3 Device for Continuous Respiratory Rate Monitoring in Healthy Adults and Chronic Obstructive Pulmonary Disease (COPD) Patients: Comparison With a Reference Benchmark
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Respiratory rate
研究概览
简要总结
This is a clinical performance testing to validate the accuracy of the Airvo 3 device with respiratory rate algorithm manufactured by Fisher & Paykel Healthcare for continuous respiratory rate monitoring.
详细描述
The Airvo 3 device is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing patients in hospitals and sub-acute facilities. The device has recently been updated with a new feature which allows continuous monitoring of patient's respiratory rate during nasal high flow therapy. This study, therefore, aims to validate the accuracy of the respiratory rate output of the Airvo 3 device. The respiratory rate output of the Airvo 3 device will be compared to the respiratory rate output of a gold standard reference device (capnography) in healthy volunteers and COPD patients to determine the level of agreement between the respiratory rate outputs of the two devices. In addition, the respiratory rate output of the Airvo 3 device will be compared to the respiratory rate output of a United States Food and Drug Administration (U.S. FDA) cleared pulse oximeter in healthy volunteers and COPD patients to determine the level of agreement between the respiratory rate outputs of the two devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Healthy adults with no known history of respiratory disease
- •Ability to provide written informed consent
- •Ability to comply with study procedures and duration
- •Out-patient adults with stable COPD: Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages 2 - 4
- •Ability to provide written informed consent
- •Ability to comply with study procedures and duration
排除标准
- •Pregnancy or lactation
- •Inability to tolerate nasal prongs
- •History of severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, electrocardiogram (ECG) electrodes, or other medical sensors
- •Inability to provide consent
- •Participants considered to be medically unsuitable to participate in the trial
研究组 & 干预措施
Intervention
This arm will receive the study intervention
干预措施: Airvo 3 with respiratory rate algorithm (Device)
结局指标
主要结局
Respiratory rate
时间窗: Through study completion, an average of 6 months
Respiratory rate outputs of investigational device and a gold standard reference device (capnography)
次要结局
- Respiratory rate(Through study completion, an average of 6 months)