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

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ClinicalTrials.gov Identifier: NCT01917500
Recruitment Status : Unknown
Verified August 2013 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : August 6, 2013
Last Update Posted : August 6, 2013
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

Brief Summary:

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.


Condition or disease
Heart or Vascular Disease

Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Official Title: Feasibility Study of Non-invasive and Continuous Measurement of Blood Pressure and Cardiac Output: Comparison to Non-invasive and Non-continuous Measurements
Study Start Date : August 2013
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2013

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



Primary Outcome Measures :
  1. Cardiac Output [ Time Frame: 1 month ]

    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



Secondary Outcome Measures :
  1. Blood Pressure [ Time Frame: 1 month ]

    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




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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01917500


Contacts
Contact: Yair Feld, Dr +972 52 5459943 yairfeld@gmail.com
Contact: Michael Kasan +972 52 5410430 michael.kasan@gmail.com

Locations
Israel
Rambam Health Care Campus Not yet recruiting
Haifa, Israel
Contact: Yair Feld, Dr    +972-52-5459943    yairfeld@gmail.com   
Principal Investigator: Yair Feld, Dr         
Sponsors and Collaborators
Rambam Health Care Campus

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01917500     History of Changes
Other Study ID Numbers: HeartBeat_V1.0
First Posted: August 6, 2013    Key Record Dates
Last Update Posted: August 6, 2013
Last Verified: August 2013

Keywords provided by Rambam Health Care Campus:
Continues non-invasive Blood pressure measurement
Continues non-invasive Cardiac Output measurement

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases