Validation of Automated Cardiac Output Measurement

July 17, 2018 updated by: University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Postoperative cardiac surgery patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Cardiac surgery patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trending ability
Time Frame: 120 minutes
Trending ability for cardiac output measurement for automated cardiac output measurement compared to pulmonary artery thermodilution
120 minutes
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
10 minutes
Trending ability
Time Frame: 120 minutes
Trending ability for cardiac output measurement for automated cardiac output measurement compared to traditional echocardiographic cardiac output measurement
120 minutes
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
10 minutes
Trending ability
Time Frame: 120 minutes
Trending ability for cardiac output measurement for traditional echocardiographic cardiac output compared to pulmonary artery thermodilution
120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

December 1, 2017

First Submitted That Met QC Criteria

December 8, 2017

First Posted (Actual)

December 14, 2017

Study Record Updates

Last Update Posted (Actual)

July 18, 2018

Last Update Submitted That Met QC Criteria

July 17, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30112017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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