To determine the accuracy of cardiac output (CO), estimated by carotid blood flow measurements using ultrasound, compared to CO estimated by PICCO thermodilution, or invasive or non-invasive pulse-contour analysis.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Decreased and nonspecific blood pressure disorders and shock
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- 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
Background summary
Diligent fluid management is instrumental to improve postoperative outcome,
cost and quality of care.
Study objective
To determine the accuracy of cardiac output (CO), estimated by carotid blood
flow measurements using ultrasound, compared to CO estimated by PICCO
thermodilution, or invasive or non-invasive pulse-contour analysis.
Study design
Prospective observational diagnostic accuracy study
Study burden and risks
Patient burden is considered to be minimal (the collection of general data from
hospital charts and (electronic) medical records, measurements are mostly
performed when anaesthetised, duration of anaesthesia is no longer than
standard operating procedure; no additional arterial/venous punctures, no
additional risk of femoral artery cannulation opposed to radial or brachial
artery cannulation, recovery after surgery is not affected by any of the study
components).
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Adult patient (age > 18 years)
- Elective coronary arterial bypass graft surgery and/or valve surgery
- Informed consent
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04593797 |
| CCMO | NL75839.018.20 |