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.

Study Overview

• Status: Unknown
• Conditions: Heart or Vascular Disease

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The trial will be conducted on a group of patients in the cardiac ward at the Rambam hospital. As long as they fall under the criteria, they will fit for the trial.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cardiac ward 10 patients; 10 patients from the cardiac ward.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: August 1, 2013
• First Submitted That Met QC Criteria: August 5, 2013
• First Posted (Estimate): August 6, 2013

Study Record Updates

• Last Update Posted (Estimate): August 6, 2013
• Last Update Submitted That Met QC Criteria: August 5, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Continues non-invasive Blood pressure measurement; Continues non-invasive Cardiac Output measurement
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: HeartBeat_V1.0