Validation of Automated Cardiac Output Measurement

Completed

• Conditions: Cardiac Output, Low; Surgery

• Registration Number: NCT03372863
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-11
• Study Start: 2017-12-01
• Study First Submitted: 2017-12-01
• Study First Submitted QC: 2017-12-08
• Study First Posted: 2017-12-14
• Primary Completion: 2018-03-01
• Study Completion: 2018-03-01
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of cardiac output measurement	10 minutes	Mean bias with limits of agreement for cardiac output measurement between automated cardiac output measurement and pulmonary artery thermodilution

Secondary Outcome Measures

Name	Time	Method
Accuracy of cardiac output measurement	10 minutes	Mean bias with limits of agreement for cardiac output measurement between traditional cardiac output measurement and pulmonary artery thermodilution
Trending ability	120 minutes	Trending ability for cardiac output measurement for traditional echocardiographic cardiac output compared to pulmonary artery thermodilution

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark