Piezoelectric Sensors for Non-invasive Continuous Arterial Blood Pressure Measurements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Arterial Blood Pressure Measurement from Non Invasive Sensor
研究概览
简要总结
The primary objective of this study is to collect training data in order to establish a method for correlating arterial blood pressure with voltage output signals from a non-invasive piezoelectric array sensor placed on the skin superficial to the radial artery.
详细描述
The primary objective of this study is to collect training data in order to establish a method for correlating arterial blood pressure with voltage output signals from a non-invasive piezoelectric array sensor placed on the skin superficial to the radial artery. The development of this sensor could allow for non-invasive continuous measurement of arterial blood pressure.
The key hypothesis is: if the piezoelectric array sensor can detect pulsatile pressure waves when placed on a near surface artery and pulse wave analysis has been shown to allow for accurate beat-to-beat estimation of blood pressure, then the device placed superficial to a near surface artery should allow for the non-invasive estimation of continuous blood pressure.
Secondary objectives include identification of any significant ergonomic and motion artifact issues that could affect sensor utilization in future applications.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18yr and older)
- •Undergoing a planned (non-emergent, non-urgent) surgical procedure at DHMC for which an invasive arterial pressure monitor is standard clinical practice. Typical surgical procedures include but are not limited to craniotomy, thoracic surgery, abdominal surgery, and others.
排除标准
- •Morbid obesity (BMI >40)
- •Radial artery depth > 1cm from skin at location of sensor
- •Peripheral vascular disease
- •Atrial fibrillation
- •Sensitivity or allergy to silicone or medical adhesive tape
- •Inability to consent.
结局指标
主要结局
Arterial Blood Pressure Measurement from Non Invasive Sensor
时间窗: Surgery start to surgery stop
The piezoelectric sensor array detects mechanical pressure from the radial artery that is transmitted to the skin and converts this to microvolt electric potentials. These microvolt signals are captured by the sensor array equipment. The microvolt signals will be time-synchronized with the standard of care invasive arterial line pressure data.
Arterial Blood Pressure Measurement from Arterial Line
时间窗: Surgery start to surgery stop
We will be capturing arterial blood pressure measurement per standard of care from arterial line. This will include systolic and diastolic measurements and will be sampled continuously from standard invasive monitoring equipment. Because of the high frequency sampling, we will be capturing the entire pulse waveform with each heartbeat.
次要结局
- Assessment of accuracy of algorithm to convert piezoelectric signal data into blood pressure measurements.(Approximately 4 months following collection of data from subjects)
研究者
Alexander T. Abess
Assistant Professor of Anesthesiology, Geisel School of Medicine, Dartmouth
Dartmouth-Hitchcock Medical Center