Feasibility Study of Non-invasive and Continuous Measurement of Blood Pressure and Cardiac Output: Comparison to Non-invasive and Non-continuous Measurements

NCT ID: NCT01917500

Last Updated: 2013-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Heart or Vascular Disease

Keywords

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Continues non-invasive Blood pressure measurement Continues non-invasive Cardiac Output measurement

Study Design

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Observational Model Type

COHORT

Study Groups

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Cardiac ward 10 patients

10 patients from the cardiac ward.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rambam Health Care Campus

Haifa, , Israel

Site Status

Countries

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Israel

Central Contacts

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Yair Feld, Dr

Role: CONTACT

Phone: +972 52 5459943

Email: [email protected]

Michael Kasan

Role: CONTACT

Phone: +972 52 5410430

Email: [email protected]

Facility Contacts

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Yair Feld, Dr

Role: primary

Other Identifiers

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HeartBeat_V1.0

Identifier Type: -

Identifier Source: org_study_id