specifieke aandoeningen zijn niet van belang voor het onderzoek
Conditions
Interventions
None listed
Sponsors
Edwards Lifesciences BMEYE
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subjects will be included if they meet the following 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: Subjects will be excluded if any of these items exist: 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 |
|---|---|
| Noninvasive monitoring of CO with the ccNexfin System is comparable to TD as determined by a bias less than 0.6 L/min. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparability of both methods as determined by Bland-Altman analysis (Bias and Percentage Error). Precision of Nexfin CO-trek versus TD will be determined. The Pearson correlation coefficient for the CO pairs of both methods will be assessed. In patients where Trendelenburg / reverse Trendelenburg positions are clinically required, changes in CO due to these interventions on hemodynamics will be measured to demonstrate concordance of devices in case of repeated measurement. Fluid administration, use of vasoactive and inotropic drugs will be recorded when available to the Investigator. | — |
Countries
Netherlands
Outcome results
None listed