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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

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

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

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
04

Study design

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

Groups and cohorts

  • Cardiac surgery patients
05

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

06

Study locations

1 site
  • Aarhus University Hospital
    Aarhus, 8200, Denmark
07

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

08

Registry details

Key details

Study ID
NCT03372863
Lead sponsor
University of Aarhus
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 ↗

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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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