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Completed

NCT Number: NCT03372863

Validation of Automated Cardiac Output Measurement

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.

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Key information

Conditions

Cardiac Output, Low Cardiovascular Diseases Heart Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital

Aarhus, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Trending ability

    Time frame: 120 minutes

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

  2. 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 conventional echocardiographic cardiac output measurement

  3. Trending ability

    Time frame: 120 minutes

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

  4. Accuracy of cardiac output measurement

    Time frame: 10 minutes

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

  5. Trending ability

    Time frame: 120 minutes

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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Validation of Automated Ultrasound Method for Measurement of Cardiac Output: A Clinical Observational Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 14, 2017
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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