Validation of Automated Cardiac Output Measurement

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03372863

Enrollment

Registered

2017-12-14

Start date

2017-12-01

Completion date

2018-03-01

Last updated

2018-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Output, Low, Surgery

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Accuracy of cardiac output measurement	10 minutes	Mean bias with limits of agreement for cardiac output measurement between automated cardiac output measurement and conventional echocardiographic cardiac output measurement
Trending ability	120 minutes	Trending ability for cardiac output measurement for automated cardiac output measurement compared to pulmonary artery thermodilution

Countries

Denmark

Outcome results