Cardiac Output, LowNCT03372863
Validation of Automated Cardiac Output Measurement
An observational study of Cardiac Output, Low and Surgery, run by University of Aarhus at 1 site in Denmark.
Trial summary
Automated software analysis now allows for quick estimation of cardiac output from the echocardiographic 5-chamber view. This study will validate the automated software method against pulmonary artery thermodilution and against conventional cardiac output measurement with echocardiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Output, Low, Surgery
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2017to 1 Mar 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
- No healthy volunteers
- Adult, Older adult
Study population: Postoperative cardiac surgery patients
Who may be able to join
- Postoperative cardiac surgery patient
- Pulmonary artery catheter in situ
- Extubated
Who cannot join
- No echocardiographic image available
- No consent
- Moderat-severe aortic insufficiency
- Moderat-severe tricuspid insufficiency
- Moderat-severe mitral valve insuffficiency
- Arythmia Intracardiac shunt Moderat-severe hemodynamic instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Automated Ultrasound Method for Measurement of Cardiac Output: A Clinical Observational Study
Automated software analysis now allows for quick estimation of cardiac output from the echocardiographic 5-chamber view. This study will validate the automated software method against pulmonary artery thermodilution and against conventional cardiac output measurement with echocardiography.
- Conditions
- Cardiac Output, Low, Surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgery patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of cardiac output measurement
Mean bias with limits of agreement for cardiac output measurement between automated cardiac output measurement and pulmonary artery thermodilution
Measured: 10 minutes
Secondary outcomes (5)
Trending ability
Trending ability for cardiac output measurement for automated cardiac output measurement compared to pulmonary artery thermodilution
Measured: 120 minutes
Accuracy of cardiac output measurement
Mean bias with limits of agreement for cardiac output measurement between automated cardiac output measurement and conventional echocardiographic cardiac output measurement
Measured: 10 minutes
Trending ability
Trending ability for cardiac output measurement for automated cardiac output measurement compared to traditional echocardiographic cardiac output measurement
Measured: 120 minutes
Accuracy of cardiac output measurement
Mean bias with limits of agreement for cardiac output measurement between traditional cardiac output measurement and pulmonary artery thermodilution
Measured: 10 minutes
Trending ability
Trending ability for cardiac output measurement for traditional echocardiographic cardiac output compared to pulmonary artery thermodilution
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start1 Dec 2017
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Output, LowStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372863
- Sponsor's protocol ID
- 30112017
- Status last verified
- Nov 2017
- First submitted
- 1 Dec 2017
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Juhl-Olsen P, Smith SH, Grejs AM, Jorgensen MRS, Bhavsar R, Vistisen ST. Automated echocardiography for measuring and tracking cardiac output after cardiac surgery: a validation study. J Clin Monit Comput. 2020 Oct;34(5):913-922. doi: 10.1007/s10877-019-00413-w. Epub 2019 Nov 1.
PubMed 31677135
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Automated Ultrasound Method for Measurement of Cardiac Output: A Clinical Observational Study
- ClinicalTrials.gov ID
- NCT03372863
- Acronym / sponsor ID
- 30112017
- Conditions
- Cardiac Output, Low, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 14 Dec 2017 (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.
Automated software analysis now allows for quick estimation of cardiac output from the echocardiographic 5-chamber view. This study will validate the automated software method against pulmonary artery thermodilution and against conventional cardiac output measurement with echocardiography.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postoperative cardiac surgery patients
Key inclusion criteria (3 listed)
- Postoperative cardiac surgery patient
- Pulmonary artery catheter in situ
- Extubated
Key exclusion criteria (6 listed)
- No echocardiographic image available
- No consent
- Moderat-severe aortic insufficiency
- Moderat-severe tricuspid insufficiency
- Moderat-severe mitral valve insuffficiency
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
Accuracy of cardiac output measurement
Time frame: 10 minutes
Mean bias with limits of agreement for cardiac output measurement between automated cardiac output measurement and pulmonary artery thermodilution
5 secondary outcomes
Trending ability
Time frame: 120 minutes
Accuracy of cardiac output measurement
Time frame: 10 minutes
Trending ability
Time frame: 120 minutes
Accuracy of cardiac output measurement
Time frame: 10 minutes
Trending ability
Time frame: 120 minutes
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 18 Jul 2018.
- Derived from this study: PubMed 31677135Juhl-Olsen P, Smith SH, Grejs AM, Jorgensen MRS, Bhavsar R, Vistisen ST. Automated echocardiography for measuring and tracking cardiac output after cardiac surgery: a validation study. J Clin Monit Comput. 2020 Oct;34(5):913-922. doi: 10.1007/s10877-019-00413-w. Epub 2019 Nov 1.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Surgery, run by University of Aarhus at 1 site in Denmark.
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 6 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 18 Jul 2018. 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 Denmark. 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?
Accuracy of cardiac output measurement (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03372863, which also lists 1 linked publication.
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 18 Jul 2018.