A Prospective, Nonrandomized, Noninterventional Study to Compare Nexfin CO-trek Cardiac Output with Thermodilution Cardiac Output

Completed

Conditions: specifieke aandoeningen zijn niet van belang voor het onderzoek
daar een clinische standaard methode voor cardiac output bepaling aanwezig moet zijn als referentie, zal het onderzoek worden uitgevoerd in high-risk surgery
N.A.

Registration Number: NL-OMON38805

Lead Sponsor: Edwards Lifesciences BMEYE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

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

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Noninvasive monitoring of CO with the ccNexfin System is comparable to TD as<br /><br>determined by a bias less than 0.6 L/min.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Comparability of both methods as determined by Bland-Altman analysis (Bias and<br /><br>Percentage Error). Precision of Nexfin CO-trek versus TD will be determined.<br /><br>The Pearson correlation coefficient for the CO pairs of both methods will be<br /><br>assessed. In patients where Trendelenburg / reverse Trendelenburg positions are<br /><br>clinically required, changes in CO due to these interventions on hemodynamics<br /><br>will be measured to demonstrate concordance of devices in case of repeated<br /><br>measurement. Fluid administration, use of vasoactive and inotropic drugs will<br /><br>be recorded when available to the Investigator.</p><br>