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A Prospective, Nonrandomized, Noninvasive Study to Compare Nexfin CO-trek Cardiac Output with Trans-Thoracic Echo Cardiography Cardiac Output

A Prospective, Nonrandomized, Noninvasive Study to Compare Nexfin CO-trek Cardiac Output with Trans-Thoracic Echo Cardiography Cardiac Output - TTE/Nexfin Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38784
Enrollment
120
Registered
2013-05-21
Start date
2013-05-22
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

specifieke aandoeningen zijn niet van belang voor het onderzoek

Interventions

No intervention for the patients
standing, exercise for the possibly enrolled volunteers.

Sponsors

Edwards Lifesciences LLC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Potential Subjects must: - be at least 18 years of age - must give signed written informed consent

Exclusion criteria

Exclusion criteria: Subjects will be excluded if any of these items exist: 1. Aortic 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.

Design outcomes

Primary

MeasureTime frame
Cardiac output obtained with the ccNexfin system and with TTE and their comparability as determined by Bland-Altman analysis.

Secondary

MeasureTime frame
Changes in cardiac output obtained with the ccNexfin system and with TTE and their comparability as determined by correlation / concordance analysis. Incidence of adverse events will be registered.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)