Demonstrate that noninvasive monitoring of cardiac output with the ccNexfin System is comparable to that with thermodilution cardiac output.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
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
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Noninvasive monitoring of CO with the ccNexfin System is comparable to TD as
determined by a bias less than 0.6 L/min.
Secondary outcome
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.
Background summary
Noninvasive measurement of cardiac output using ccNexfin allows monitoring of
almost any patient in the OR. Consequently, fluids for individual patients may
be managed more appropriately, leading to less post-operative complications and
morbidity.
Study objective
Demonstrate that noninvasive monitoring of cardiac output with the ccNexfin
System is comparable to that with thermodilution cardiac output.
Study design
Prospective, nonrandomized, noninterventional validation study.
Study burden and risks
Burden and risks are negligible. The study is not group related.
Hoogoorddreef, Centerpoint 1, 4e verdieping 60
Amsterdam Zuidoost 1101 BE
NL
Hoogoorddreef, Centerpoint 1, 4e verdieping 60
Amsterdam Zuidoost 1101 BE
NL
Listed location countries
Age
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
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 | NL44270.018.13 |