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Clinical Trials/NL-OMON38805
NL-OMON38805
Completed
Not Applicable

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

Edwards Lifesciences BMEYE0 sites40 target enrollmentTBD
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Conditionsspecifieke aandoeningen zijn niet van belang voor het onderzoekdaar een clinische standaard methode voor cardiac output bepaling aanwezig moet zijn als referentie, zal het onderzoek worden uitgevoerd in high-risk surgeryN.A.

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
specifieke aandoeningen zijn niet van belang voor het onderzoek
Sponsor
Edwards Lifesciences BMEYE
Enrollment
40
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational non invasive

Investigators

Sponsor
Edwards Lifesciences BMEYE

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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