Validation of a Sensor for Non-Invasive Measurement of Vital Signs, Hemodynamic Parameters and Time-Dependent Physiological Waveforms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Fluids
研究概览
简要总结
Subjects will be measured with both a sensor and a reference device
详细描述
Subjects will participate in a study measuring a single set of paired values. In this case, measurements will take roughly 2-30 minutes to complete, and will involve: 1) attaching the sensor on the subject; 2) attaching one or more reference devices to the subject; 3) making measurements with both the sensor and reference device, either simultaneously or sequentially; and 4) collecting and analyzing the paired value.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is at least 18 (eighteen) years of age at screening.
- •Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
- •Subject selection will not be based on age, height, or weight.
- •Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition as well as the features of the investigational device tested during the study.
排除标准
- •Subject is participating in another clinical study that may affect the results of either study.
- •Subjects that are pregnant will not be included in the study.
- •Subject is unable or not willing to wear electrode patches as required for a period of up to 168 hours.
- •Subject is considered by the Principal Investigator to be medically unsuitable for study participation.
结局指标
主要结局
Fluids
时间窗: 3-36 Months
Observation of fluid measurement from Sensor (ohms)
Comparison of Blood Pressure Measurement from Sensor with Human Auscultation measurement of Blood Pressure.
时间窗: 3-36 Months
Comparison of Blood Pressure Measurement from Sensor with Human Auscultation measurement of Blood Pressure. Specifically, Systolic Blood Pressure and Diastolic Blood Pressure with units of millimeters of mercury (mmHg) will be compared.
Heart Rate Variability
时间窗: 3-36 Months
Observation of heart rate variability from Sensor (milliseconds)
Respiration Rate
时间窗: 3-36 Months
Observation of respiration rate from Sensor (breaths/min)
Heart Rate
时间窗: 3-36 Months
Observation of heart rate measurement from Sensor (beats/min)
次要结局
未报告次要终点