Heart or Vascular Disease Clinical Trial
Official title:
Feasibility Study of Non-invasive and Continuous Measurement of Blood Pressure and Cardiac Output: Comparison to Non-invasive and Non-continuous Measurements
The objectives of this clinical trial is to validate a S/W application to compare the
calculations of Hemodynamic parameters like Continuous blood pressure (BP) and Continuous
cardiac output (CO). This Hemodynamic parameters are computed from Pulse Oximeter
(PhotoPlethysmograph or PPG) signal with results obtained by NIBP intermittent measurements
and Echocardiography. The first phase of the study will be done on 10 patients of the
Cardiology dept.- Cardiac ICU, that have routine measurements of BP and CO using
Echocardiography.
The HeartBeat system combines an FDA/CE approved watch-like Pulse Oximeter for acquiring the
data and a Smartphone S/W application that serves as the Hemodynamic calculator. The S/W
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 CO in a continuous and graphical way on
a standard Android Smartphone. 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.
| Status | Not yet recruiting |
| Enrollment | 10 |
| Est. completion date | September 2013 |
| Est. primary completion date | September 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 20 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Male and females - Between the ages of 20-70 years old Exclusion Criteria: - Over 70 years old - under 20 years old - Supportive blood pressure - Severe Sepsis - Ventilated patients - Supported by Amines - Patients in state of Shock |
Observational Model: Cohort
| Country | Name | City | State |
|---|---|---|---|
| Israel | Rambam Health Care Campus | Haifa |
| Lead Sponsor | Collaborator |
|---|---|
| Rambam Health Care Campus |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cardiac Output | Patients in the cardiac department pass an echo-cardiograph procedure to measure their cardiac output. When it is done, we will attach our oximeter to the patient and using the application we will calculate Cardiac Output. We will compare between both measurements |
1 month | No |
| Secondary | Blood Pressure | Patients in the cardiac department have their blood pressure often measured . When it is done, we will attach our oximeter to the patient and using the application we will calculate our blood pressure. We will compare between both measurements |
1 month | No |