Cardiac output measurement Circulatory System
Conditions
Interventions
PRIOR TO PROCEDURE
The standard pre-evaluation will include:
1. Informed consent
2. Screening for inclusion and exclusion criteria
3. Ba
Sponsors
Edwards Lifesciences LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must be at least 18 years of age 2. Subjects must give signed written informed consent 3. Subjects' height and weight must be accurately obtained prior to study start
Exclusion criteria
Exclusion criteria: 1. Aortic or tricuspid valve regurgitation 2. Aortic stenosis or aneurysms 3. History of uncontrolled cardiac arrhythmia 4. Any peripheral vascular disease or conditions such as Raynaud's disease or Buerger's disease 5. Insufficient perfusion of the digits 6. Inability to place the finger cuff appropriately due to subject anatomy or condition 7. Known pregnancy 8. Patients being treated with an intra-aortic balloon pump 9. Patient is currently participating in an investigational drug or another device study that clinically interferes with the study endpoints
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoint is the acquisition of the cardiac output values of the two devices to meet an acceptance criterion of Bias < 0.6 liters per minute. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study endpoints (and acceptance criteria) are: 1. The comparability of both methods as determined by Bland-Altman analysis (Bias < 0.6, Percentage Error < 40.4) 2. The precision of Nexfin CO-trek versus TD (no acceptance criterion) 3. The Pearson correlation coefficient of the CO pairs of the two methods (no acceptance criterion) | — |
Countries
Netherlands, United States of America
Outcome results
None listed