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The accuracy of ultrasound derived carotid artery flow compared to conventional intravascular methods

The accuracy of ultrasound derived carotid artery flow compared to conventional intravascular methods - E-FLOW 2

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49326
Enrollment
18
Registered
2021-02-24
Start date
2021-06-09
Completion date
Unknown
Last updated
2024-04-09

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

Conditions

blood flow measurements non-invasive cardiac output monitoring

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Adult patient (age > 18 years) - Elective coronary arterial bypass graft surgery and/or valve surgery - Informed consent

Exclusion criteria

Exclusion criteria: - Significant aortic valve stenosis > 30% without indication for valve repair, or abnormal anatomy of aortic, femoral, carotid or brachial artery 16 - Cerebrovascular accident - Atrial fibrillation or arrhythmias - COPD stage 3-4 - Severe heart valve regurgitation or stenosis - Inability to measure carotid artery blood flow or too low bifurcation - Contra-indications for femoral arterial catheter placement (e.g., vascular graft)

Design outcomes

Primary

MeasureTime frame
The accuracy of CO measured by ultrasound of the carotid blood flow will be compared to (1) thermodilution cardiac output measurement, (2) pulse-contour cardiac output measurement and (3) pulse-contour based non-invasive cardiac output measurement. These measurements are performed shortly after defined events in ICU patients when changes in the SVR are expected.The accuracy will be assessed by Bland-Altman analysis. We will describe if the limit of agreements are between ±30%.

Secondary

MeasureTime frame
- The variability or trending capability of CO measured by ultrasound of the carotid blood flow will be compared to (1) thermodilution cardiac output measurement, (2) pulse-contour cardiac output measurement and (3) pulse-contour based non-invasive cardiac output measurement calculated by concordance analysis and polar analysis, in short change in CO by ultrasound compared to change in CO by the reference CO. 13 - The bias of carotid blood flow measurement with ultrasound compared to (1) thermodilution cardiac output measurement, (2) pulse-contour cardiac output measurement and (3) pulse-contour based non-invasive cardiac output measurement calculated by Bland-Altman analysis and mean error. 13 - The response to therapy (directional changes) of carotid blood flow measurement with ultrasound compared to (1) thermodilution cardiac output measurement, (2) pulse-contour cardiac output measurement and (3) pulse-contour based non-invasive cardiac output measurement calculated by polar analysis. 13

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)