Comparison Study of Non-invasive Measurement of Blood Pressure and Cardiac Output During Stress Echocardiography
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Cardiac Output
研究概览
简要总结
The objectives of the clinical trial is to validate hemodynamic parameters (Blood pressure and Cardiac Output) generated by an application coupled with an off-the-shelf pulse oximeter. The validation will be done by comparing the generated information to data gathered while performing Stress Echocardiography. The first phase of the study will be done on 10 patients undergoing a Stress Echocardiography test at the cardiology department at Meir Hospital
详细描述
The HeartBeat system combines an FDA/CE approved watch-like Pulse Oximeter for acquiring the data and an android software application that serves as the Hemodynamic calculator. The application performs POST-PROCESSING of the PhotoPlethismoGraphic (PPG) signal (Normally the PPG signal in Pulse Oximeters is used only to compute heart rate and SpO2). The raw data is transferred from the watch oximeter to the smartphone using a standard Bluetooth protocol.
The Post-processing uses wavelet signal processing to estimate and display certain Hemodynamic parameters like Blood Pressure (BP) and Cardiac Output (CO) in a continuous and graphical way on a standard Android device. In addition to the standard heart rate and SpO2, the application displays the measured PPG signal and estimated continues BP and CO.
HeartBeat is the only device that can non-invasively estimate Continuous BP and its Cardiac Output component and the resistance component in a mobile wearable device. Differentiating between these 2 components can play a major role in helping the doctor to understand the effect of cardiovascular medications and Lifestyle interventions.
The trial will compare blood pressure and cardiac output parameters measured during Stress Echocardiography using an echo cardiograph and standard sphygmomanometer to the parameters generated by the application.
Trial goals
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients referred to an Stress Echocardiography test for cardiac diagnostics
- •Male and Female
- •Between 18 to 90 years old
排除标准
- •Under the age of 18 or over 90 years old
- •Patients in Shock
- •Patients with Moderate or Severe valvular disease
- •Patients with severe sepsis
- •Inadequate jurisprudence patients
- •Patients supported by Amines
结局指标
主要结局
Cardiac Output
时间窗: Change from Baseline in Cardiac Output at 30 minutes
Measurement of Cardiac Output at the beginning and the end of the test (30 minutes)
次要结局
- Blood Pressure(Change from Baseline in Systolic and Diastolic blood pressure at 30 minutes)
- Heart rate(Change from Baseline in heart rate at 30 minutes)