Blood PressureNCT04685733
Caretaker Hemodynamic Parameters Validation
An observational study of Blood Pressure and Cardiac Output, run by CareTaker Medical LLC at 1 site in United States.
Trial summary
Comparison studies comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Cardiac Output, Left Ventricular Ejection Time
- What is being tested?
- Non-invasive hemodynamic measurements
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 31 Dec 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be patients, > 18 years of age, who are able and willing to participate and have given written assent
Who may be able to join
- 18 years of age, who are able and willing to participate and have given written assent
Who cannot join
- Unable to give written assent
- <18 years of age
- No or poor finger pulse, as determined through visual inspection for ischemic hands
Trial locations and contacts
1 site in 1 country.
About this study
Comparison studies comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.
Read the detailed description
Comparison studies comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.
Specifically, continuous beat-by-beat blood pressure readings against arterial catheter readings, continuous beat-by-beat left ventricular ejection times (LVET) against matching LVETs obtained from central catheters, cardiac output (CO) and stroke volume (SV) measures against thermo-dilution and Fick measurements, and standard HRV parameters based on Caretaker-provided inter-beat intervals (IBI) against the same HRV parameters obtained from ECG-based IBIs.
- Being tested
- Non-invasive hemodynamic measurements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive hemodynamic measurementsDevice
Non-invasive hemodynamic measurements
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Comparison of blood pressure, LVET and CO/SV measures with respective Gold Standards Receives: Device: Non-invasive hemodynamic measurements | |
| Group 2 | Comparison of blood pressure and HRV measures with respective Gold Standards Receives: Device: Non-invasive hemodynamic measurements | |
| Group 3 | Comparison of blood pressure and CO/SV measures with respective Gold Standards Receives: Device: Non-invasive hemodynamic measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure performance comparison
Comparison with arterial catheter-derived blood pressure, guidelines call for meeting a bias of 5 mmHg and a standard deviation of 8 mmHg
Measured: Paired beat-by-beat readings over maximum of 2.5 hours session length
Cardiac output performance comparison
Comparison with thermo-dilution-based cardiac output, agreement within 1 l/min.
Measured: Paired measurements over approximately 1 hour time frame
Left ventricular ejection time comparison
Comparison with LVET derived from central catheter signal traces, agreement within 20 msec.
Measured: Paired measurements over approximately 1 hour time frame
Heart rate variability measures comparison
Comparison with 5 HRV ECG-derived measures, agreement within performance of VitalConnect predicate device
Measured: Paired beat-by-beat readings over maximum of 2.5 hours session length
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start1 Feb 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- CareTaker Medical LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Virginia, Yale University, Orange County Research Center
- Responsible party
- Sponsor
- Investigators
- Martin Baruch, PhD, Principal investigator, Caretaker Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685733
- Sponsor's protocol ID
- Hemo_001
- Status last verified
- Dec 2020
- First submitted
- 22 Dec 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caretaker Hemodynamic Parameters Validation
- ClinicalTrials.gov ID
- NCT04685733
- Acronym / sponsor ID
- Hemo_001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- CareTaker Medical LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Virginia, Yale University, Orange County Research Center
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 28 Dec 2020 (actual)
- 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.
Comparison studies comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.
Detailed description
Comparison studies comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.
Specifically, continuous beat-by-beat blood pressure readings against arterial catheter readings, continuous beat-by-beat left ventricular ejection times (LVET) against matching LVETs obtained from central catheters, cardiac output (CO) and stroke volume (SV) measures against thermo-dilution and Fick measurements, and standard HRV parameters based on Caretaker-provided inter-beat intervals (IBI) against the same HRV parameters obtained from ECG-based IBIs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: Non-invasive hemodynamic measurementsComparison of blood pressure, LVET and CO/SV measures with respective Gold Standards |
| Group 2 | – | Device: Non-invasive hemodynamic measurementsComparison of blood pressure and HRV measures with respective Gold Standards |
| Group 3 | – | Device: Non-invasive hemodynamic measurementsComparison of blood pressure and CO/SV measures with respective Gold Standards |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be patients, > 18 years of age, who are able and willing to participate and have given written assent
Key inclusion criteria (1 listed)
- 18 years of age, who are able and willing to participate and have given written assent
Key exclusion criteria (3 listed)
- Unable to give written assent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive hemodynamic measurementsNon-invasive hemodynamic measurements | Device | Group 1, Group 2, Group 3 |
Primary outcome
Blood pressure performance comparison
Time frame: Paired beat-by-beat readings over maximum of 2.5 hours session length
Comparison with arterial catheter-derived blood pressure, guidelines call for meeting a bias of 5 mmHg and a standard deviation of 8 mmHg
Cardiac output performance comparison
Time frame: Paired measurements over approximately 1 hour time frame
Comparison with thermo-dilution-based cardiac output, agreement within 1 l/min.
Left ventricular ejection time comparison
Time frame: Paired measurements over approximately 1 hour time frame
Comparison with LVET derived from central catheter signal traces, agreement within 20 msec.
Heart rate variability measures comparison
Time frame: Paired beat-by-beat readings over maximum of 2.5 hours session length
Comparison with 5 HRV ECG-derived measures, agreement within performance of VitalConnect predicate device
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
Martin Baruch, PhD principal investigator
Caretaker Medical
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 Blood Pressure and Cardiac Output, run by CareTaker Medical LLC at 1 site in United States.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 28 Dec 2020. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure performance comparison (time frame: Paired beat-by-beat readings over maximum of 2.5 hours session length). The study lists 4 primary outcomes in all. 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 28 Dec 2020.