Cardiac Output, LowNCT04774978
Real-time Continuous Cardiac Output Measurements
A study testing TTE in people with Cardiac Output, Low, run by Rijnstate Hospital.
Trial summary
Study to assess the feasibility of real-time automatic cardiac output measurements using transthoracic echocardiography (TTE) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Output, Low
- What is being tested?
- TTE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 1 Jul 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Intensive Care patients ( > 18 years)
Who cannot join
- Pregnancy
- Atrial fibrillation or other irregular heart rhythm
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Real-time Automatic Continuous Cardiac Output Measurements Using Transthoracic Echocardiography (TTE) in ICU-patients in Comparison to Flotrac Measurements
Study to assess the feasibility of real-time automatic cardiac output measurements using transthoracic echocardiography (TTE)
Read the detailed description
Rationale: Study to assess the feasibility of real-time automatic cardiac output measurements using transthoracic echocardiography (TTE)
Objective: To assess the correlation and feasibility of real-time automatic continuous cardiac output measurements using transthoracic ultrasound (TTE) in adult ICU-patients in comparison to Flotrac measurements
Study design: prospective, feasibility study
Study population: Adult Intensive Care patients ( > 18 years)
Intervention (if applicable):
Consecutive adult patients on the ICU in which the there is an indication for continuous cardiac output measurements.
Main study parameters/endpoints:
- Percentage of patients in which continuous cardiac output can be measured using TTE
- Correlation between continuous TTE and Flotrac measurements
- Conditions
- Cardiac Output, Low
- Being tested
- TTE
- Keywords
- Cardiac output, TTE
- 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.
TTEDevice
Transthoracic echocardiography
| Study group | Role | What they receive |
|---|---|---|
| Cardiac output measurements | Experimental | Cardiac output will be measured using TTE continuously with ProbeFix Receives: Device: TTE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients in which the ProbeFix can be used continuously
Percentages will be reported
Measured: 2 months
Secondary outcomes (1)
Correlation between continuous TTE and Flotrac
Bland-Altman plot will be reported
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Mar 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Jul 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774978
- Sponsor's protocol ID
- RijnstateH
- Status last verified
- Feb 2021
- First submitted
- 25 Feb 2021
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Automatic Continuous Cardiac Output Measurements Using Transthoracic Echocardiography (TTE) in ICU-patients in Comparison to Flotrac Measurements
- ClinicalTrials.gov ID
- NCT04774978
- Acronym / sponsor ID
- RijnstateH
- Conditions
- Cardiac Output, Low
- Keywords
- Cardiac output, TTE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 1 Mar 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.
Study to assess the feasibility of real-time automatic cardiac output measurements using transthoracic echocardiography (TTE)
Detailed description
Rationale: Study to assess the feasibility of real-time automatic cardiac output measurements using transthoracic echocardiography (TTE)
Objective: To assess the correlation and feasibility of real-time automatic continuous cardiac output measurements using transthoracic ultrasound (TTE) in adult ICU-patients in comparison to Flotrac measurements
Study design: prospective, feasibility study
Study population: Adult Intensive Care patients ( > 18 years)
Intervention (if applicable):
Consecutive adult patients on the ICU in which the there is an indication for continuous cardiac output measurements.
Main study parameters/endpoints:
- Percentage of patients in which continuous cardiac output can be measured using TTE
- Correlation between continuous TTE and Flotrac measurements
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac output measurements | Experimental | Device: TTECardiac output will be measured using TTE continuously with ProbeFix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult Intensive Care patients ( > 18 years)
Key exclusion criteria (2 listed)
- Pregnancy
- Atrial fibrillation or other irregular heart rhythm
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 |
|---|---|---|
| TTETransthoracic echocardiography | Device | Cardiac output measurements |
Primary outcome
Patients in which the ProbeFix can be used continuously
Time frame: 2 months
Percentages will be reported
1 secondary outcome
Correlation between continuous TTE and Flotrac
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing TTE in people with Cardiac Output, Low, run by Rijnstate Hospital.
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 2 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 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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 B Baten (088 - 0057870, BBaten@rijnstate.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients in which the ProbeFix can be used continuously (time frame: 2 months). 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 1 Mar 2021; AzTrials last refreshed its copy on 26 Oct 2026.