Validation of Automated Cardiac Output Measurement

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03372863
• Other study ID #: 30112017
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: March 1, 2018

Study information

• Verified date: November 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Output, Low
• Surgery

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

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