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CompletedNCT03372863Updated Jul 18, 2018

Validation of Automated Cardiac Output Measurement

An observational study in Cardiac Output, Low and Surgery, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-18.

Sponsored by University of Aarhus · Observational

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Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiac Output, Low
  • Surgery

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03

In context

Cardiac Output, Low

99 studies on the registry are indexed under Cardiac Output, Low; 15 are open to participants now.

This study's enrollment of 50 is below the median of 66 across 48 observational studies indexed under Cardiac Output, Low.

Browse Cardiac Output, Low studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Postoperative cardiac surgery patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Postoperative cardiac surgery patient
  • Pulmonary artery catheter in situ
  • Extubated

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • Cardiac surgery patients
06

What researchers measure

Primary outcomes

  1. Accuracy of cardiac output measurement

    Mean bias with limits of agreement for cardiac output measurement between automated cardiac output measurement and pulmonary artery thermodilution

    Time frame: 10 minutes

Secondary outcomes

  1. Trending ability

    Trending ability for cardiac output measurement for automated cardiac output measurement compared to pulmonary artery thermodilution

    Time frame: 120 minutes

  2. 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

    Time frame: 10 minutes

  3. Trending ability

    Trending ability for cardiac output measurement for automated cardiac output measurement compared to traditional echocardiographic cardiac output measurement

    Time frame: 120 minutes

  4. Accuracy of cardiac output measurement

    Mean bias with limits of agreement for cardiac output measurement between traditional cardiac output measurement and pulmonary artery thermodilution

    Time frame: 10 minutes

  5. Trending ability

    Trending ability for cardiac output measurement for traditional echocardiographic cardiac output compared to pulmonary artery thermodilution

    Time frame: 120 minutes

07

Study locations

1 site
  • Aarhus University Hospital
    Aarhus, 8200, Denmark
08

References and documents

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 ↗

Individual participant data

Plan to share: Yes

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Mar 2018, 3 months.

Of 22 observational studies under Cardiac Output, Low, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 34. This study's 3 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 1, 2017
First posted
Dec 14, 2017
StartActual
Dec 1, 2017
Primary completionActual
Mar 1, 2018
CompletionActual
Mar 1, 2018
Last update
Jul 18, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03372863
Responsible party
Sponsor
First posted
Dec 14, 2017
Start date
Dec 1, 2017
Primary completion
Mar 1, 2018
Completion
Mar 1, 2018
Last update
Jul 18, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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