NCT03372863

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 14, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

July 18, 2018

Status Verified

November 1, 2017

Enrollment Period

3 months

First QC Date

December 1, 2017

Last Update Submit

July 17, 2018

Conditions

Cardiac Output, LowSurgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Trending ability

    120 minutes

  • Accuracy of cardiac output measurement

    10 minutes

  • Trending ability

    120 minutes

  • Accuracy of cardiac output measurement

    10 minutes

  • Trending ability

    120 minutes

Study Arms (1)

Cardiac surgery patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Postoperative cardiac surgery patients

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related Publications (1)

  • Juhl-Olsen P, Smith SH, Grejs AM, Jorgensen MRS, Bhavsar R, Vistisen ST. Automated echocardiography for measuring and tracking cardiac output after cardiac surgery: a validation study. J Clin Monit Comput. 2020 Oct;34(5):913-922. doi: 10.1007/s10877-019-00413-w. Epub 2019 Nov 1.

    PMID: 31677135DERIVED

MeSH Terms

Conditions

Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2017

First Posted

December 14, 2017

Study Start

December 1, 2017

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

July 18, 2018

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will share

Locations

DK(1)