Calibration of the Average Breathing Rate Measurement of the Cloud DX Pulsewave Health Monitor (PAD-2A) Device (CCV-3)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Breathing rate
研究概览
简要总结
The purpose of this study is to calibrate the average breathing rate measurement of the PAD-2A device to be within ±2 breaths per minute of clinical capnography breathing rate measurements.
详细描述
The plan for this study is to calibrate the average breathing rate measurement of the PAD-2A device with the breathing rate measurement of a standard clinical capnography device. The data will be collected and analyzed in order to calibrate the PAD-2A device via the capnography measures by adjusting the device algorithm for the breathing rate measurements to be within ±2 breaths per minute. Additionally, the secondary objective of this study is to compare the clinical standard respiratory rate measurement of capnography with the respiratory rate measurements of other standard clinical respiratory devices (i.e. nasal pressure transducer, thermistor, and the respiratory inductance plethysmography (RIP) belts of the chest and abdomen).
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ≥ 19 years of age (minimum 30% male/female)
- •Wrist circumference between 13.5cm - 23cm (5.3 in. - 9.1in.)
- •Specifically for this test device, the wrist size of the consented participants will be distributed accordingly for a Gaussian distribution:
- •Lowest Octile: ≥ 13.5cm to < 14.7cm Lower Quarter: ≥ 13.5cm to < 15.9cm Lower-Middle Quarter: ≥ 15.9cm to < 18.3cm Upper-Middle Quarter: ≥ 18.3cm to < 20.7cm Upper Quarter: ≥ 20.7cm to ≤ 23.0cm Highest Octile: ≥ 21.9cm to ≤ 23.0cm
- •Willing to volunteer to participate and to sign the study specific informed consent form
排除标准
- •Wrist circumference less than 13.5cm (5.3 in.) or greater than 23cm (9.1 in)
- •Hand or body tremors
- •Canadian Cardiovascular Society (CCS) grade III or IV angina pectoris (chest pain)
- •Unexplained shortness of breath at rest
- •History of seizures (except childhood febrile seizures)
- •History of unexplained syncope (fainting)
- •A musculoskeletal disorder that prevents a non-invasive device to be inflated/deflated on the arm
- •Unwilling to volunteer to participate and to sign the study specific informed consent form
结局指标
主要结局
Breathing rate
时间窗: Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 60 seconds).
Standard clinical thermistor via nasal cannula (breaths per minute)
次要结局
- Breathing rate(Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 60 seconds).)