Cardiac Output, LowNCT05035719
Comparison Studies Comparing Hemodynamic Parameters Provided by the Caretaker Against Respective Gold Standard References
An observational study of Cardiac Output, Low, 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
- Cardiac Output, Low
- What is being tested?
- non-invasive cardiac output monitor
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 31 Mar 2022
- 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: Cardiac patients
Who may be able to join
- 18 years of age
- able and willing to participate
- provide written consent
Who cannot join
- Unable to give written consent
- <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.
United States1 site, 1 recruiting
- Recruiting
Cooper University Hospital
Camden, New Jersey, 08103
Irwin Gratz, DO, 856-342-2425, GRATZ-IRWIN@cooperhealth.edu
About this study
Official title: Comparison Studies Comparing Hemodynamic Parameters Provided by the Caretaker
Comparison studies comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.
Read the detailed description
Comparison study comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.
Specifically, continuous beat-by-beat blood pressure readings against arterial catheter readings and cardiac output (CO) and stroke volume (SV) measures against thermo-dilution measurements
- Conditions
- Cardiac Output, Low
- Being tested
- non-invasive cardiac output monitor
- Medical subject headings
- Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive cardiac output monitorDevice
Also called Equivalence of Caretaker cardiac output reading to reference standard
Equivalence of Caretaker cardiac output reading to reference standard
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Cardiac patients Receives: Device: non-invasive cardiac output monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output performance comparison
Comparison with thermo-dilution-based cardiac output, agreement within 1 l/min.
Measured: Change between several paired readings over the course of cardiac surgery (typically 2-4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Mar 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Output, LowStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CareTaker Medical LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Cooper Health System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035719
- Sponsor's protocol ID
- Hemo_002
- Status last verified
- Aug 2021
- First submitted
- 31 Aug 2021
- Last updated
- 5 Sep 2021
- 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 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Studies Comparing Hemodynamic Parameters Provided by the Caretaker
- ClinicalTrials.gov ID
- NCT05035719
- Acronym / sponsor ID
- Hemo_002
- Conditions
- Cardiac Output, Low
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- CareTaker Medical LLCIndustry (pharma, biotech, devices)
- Collaborators
- The Cooper Health System
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 5 Sep 2021 (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 study comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.
Specifically, continuous beat-by-beat blood pressure readings against arterial catheter readings and cardiac output (CO) and stroke volume (SV) measures against thermo-dilution measurements
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: non-invasive cardiac output monitorCardiac patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac patients
Key inclusion criteria (3 listed)
- 18 years of age
- able and willing to participate
- provide written consent
Key exclusion criteria (3 listed)
- Unable to give written consent
- <18 years of age
- No or poor finger pulse, as determined through visual inspection for ischemic hands
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 cardiac output monitorAlso: Equivalence of Caretaker cardiac output reading to reference standardEquivalence of Caretaker cardiac output reading to reference standard | Device | Group 1 |
Primary outcome
Cardiac output performance comparison
Time frame: Change between several paired readings over the course of cardiac surgery (typically 2-4 hours)
Comparison with thermo-dilution-based cardiac output, agreement within 1 l/min.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- 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.
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 Cardiac Output, Low, 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 3 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: status not confirmed, as of the sponsor's last update on 5 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin C Baruch, PhD (434 978-7000 ext. 103, martin@caretakermedical.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output performance comparison (time frame: Change between several paired readings over the course of cardiac surgery (typically 2-4 hours)). 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 5 Sep 2021.