Heart or Vascular DiseaseNCT01917500
Feasibility Study of Non-invasive and Continuous Measurement of Blood Pressure and Cardiac Output: Comparison to Non-invasive and Non-continuous Measurements
An observational study of Heart or Vascular Disease, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart or Vascular Disease
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2013to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Male and females
- Between the ages of 20-70 years old
Who cannot join
- Over 70 years old
- under 20 years old
- Supportive blood pressure
- Severe Sepsis
- Ventilated patients
- Supported by Amines
- Patients in state of Shock
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rambam Health Care Campus
Haifa
Yair Feld, Dr, +972-52-5459943, yairfeld@gmail.com
Yair Feld, Dr
About this study
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.
Read more
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.
- Conditions
- Heart or Vascular Disease
- Keywords
- Continues non-invasive Blood pressure measurement, Continues non-invasive Cardiac Output measurement
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac ward 10 patients | 10 patients from the cardiac ward. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (1)
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart or Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917500
- Sponsor's protocol ID
- HeartBeat_V1.0
- Status last verified
- Aug 2013
- First submitted
- 1 Aug 2013
- Last updated
- 6 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Non-invasive and Continuous Measurement of Blood Pressure and Cardiac Output: Comparison to Non-invasive and Non-continuous Measurements
- ClinicalTrials.gov ID
- NCT01917500
- Acronym / sponsor ID
- HeartBeat_V1.0
- Conditions
- Heart or Vascular Disease
- Keywords
- Continues non-invasive Blood pressure measurement, Continues non-invasive Cardiac Output measurement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 6 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac ward 10 patients | – | –10 patients from the cardiac ward. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Male and females
- Between the ages of 20-70 years old
Key exclusion criteria (7 listed)
- Over 70 years old
- under 20 years old
- Supportive blood pressure
- Severe Sepsis
- Ventilated patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Blood Pressure
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart or Vascular Disease, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yair Feld, Dr (+972 52 5459943, yairfeld@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Output (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2013.