Comparison Study of Non-invasive Measurement of Blood Pressure and Cardiac Output During Stress Echocardiography
研究概览
详细说明
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
- Feasibility tests for the HeartBeat application as a tool for monitoring BP and CO changes over time
- Compare BP and CO parameters generated by the applications to the ones measured by standard non-invasive equipment during a Stress Echocardiography
- Calculate additional parameters such as stroke volume, systematic vascular resistance and cardiac index
研究类型
注册 (预期的)
联系人和位置
学习地点
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Kfar Saba、以色列、4428164
- Meir health center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patients referred to an Stress Echocardiography test for cardiac diagnostics
- Male and Female
- Between 18 to 90 years old
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Cardiac Output
大体时间：Change from Baseline in Cardiac Output at 30 minutes
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Measurement of Cardiac Output at the beginning and the end of the test (30 minutes)
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Change from Baseline in Cardiac Output at 30 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Blood Pressure
大体时间：Change from Baseline in Systolic and Diastolic blood pressure at 30 minutes
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Change from Baseline in Systolic and Diastolic blood pressure at 30 minutes
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Heart rate
大体时间：Change from Baseline in heart rate at 30 minutes
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Measurement of Systolic and Diastolic blood pressure at the beginning and the end of the test
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Change from Baseline in heart rate at 30 minutes
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合作者和调查者
调查人员
- 首席研究员：Yoram Neuman, MD、Meir Health Facility
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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