The present study aims to demonstrate that non-invasive determination of CO with ccNexfin is comparable to the CO of the TTE.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
specifieke aandoeningen zijn niet van belang voor het onderzoek; daar het onderzoek in een cardiologische omgeving uitgevoerd zal worden, zullen meeste proefpersonen cardiologische aandoeningen hebben
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cardiac output obtained with the ccNexfin system and with TTE and their
comparability as determined by Bland-Altman analysis.
Secondary outcome
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.
Background summary
Noninvasive measurement of cardiac output using ccNexfin allows monitoring of
almost any patient in the operating room. Consequently, fluids for individual
patients may be managed more appropriately, leading to less post-operative
complications and morbidity.
Study objective
The present study aims to demonstrate that non-invasive determination of CO
with ccNexfin is comparable to the CO of the TTE.
Study design
Prospective, non-randomized, non-invasive
Intervention
No intervention for the patients; standing, exercise for the possibly enrolled
volunteers.
Study burden and risks
Burden and risks are negligible. The study is not group related.
Centerpoint 1, 4e verdieping, Hoogoorddreef 60
Amsterdam 1101 BE
NL
Centerpoint 1, 4e verdieping, Hoogoorddreef 60
Amsterdam 1101 BE
NL
Listed location countries
Age
Inclusion criteria
Potential Subjects must:
- be at least 18 years of age
- must give signed written informed consent
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43819.094.13 |