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Transpulmonary Thermodilution Measurements in Patients With Heart Diseases

Transpulmonary Thermodilution Measurements in Patients With Heart Diseases

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02035007
Enrollment
70
Registered
2014-01-14
Start date
2009-07-31
Completion date
2014-12-31
Last updated
2015-06-26

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

Conditions

Heart Diseases

Brief summary

The purpose of this study is to examine the validation of the PiCCO (Pulse Contour Cardiac Output)-derived transpulmonary thermodilution technology in patients with heart diseases.

Detailed description

* How do PiCCO and PAC (pulmonary artery catheter) derived hemodynamic variables change in different cardiac pathologies? * How do PiCCO hemodynamic variables compare to transthoracic echocardiographic parameters in different cardiac pathologies? * How does GEDV (global enddiastolic volume) correlate with left ventricles end-diastolic volume (LVEDV) assessed by LV (left ventricle) ventriculography and echocardiography? * How do PiCCO cardiac function variables (GEF \[global ejection fraction\]; CFI \[cardiac function index\]) correlate with LV dP/dt max, LVEF (left ventricular ejection fraction) assessed by LV ventriculography and echocardiography, LVFAC (left ventricular fractional area of change), LV stroke work index (LVSWI) and cardiac power (CP)? * How does GEDV compare to LVEDV and left ventricular end-diastolic pressure (LVEDP) as assessed by the pulmonary artery occlusion pressure (PAOP)? * How does right ventricular function influence GEDV, GEF and CFI?

Interventions

DEVICEPiCCO Catheter (Pulsiocath 5F)

Measuring of PiCCO derived values

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Coronary heart disease without impaired left ventricular function \[LV-EF \> 50%\] (n=10, control group) * Coronary heart disease with impaired left ventricular function \[LV-EF \< 50%\] (n=10) * Dilated cardiomyopathy (n=10), * Aortic valve stenosis (n=10), * Mitral valve regurgitation (n=10), * Diastolic left ventricular dysfunction (n=10) and * Right heart failure (n=10)

Exclusion criteria

* Patients with catecholamine dependent cardiogenic shock, severe respiratory distress because of pulmonary oedema, intubated patients, patients with atrial fibrillation, atrioventricular conduction abnormalities, and slow ventricular tachycardia will not be included. * Moreover patients not being able to give informed consent are excluded. Even more, pregnant women are excluded from the study due to the radiation exposure in line with heart catheterization. A pregnancy test will be performed prior to participating with this study. * The age does not represent an exclusion criterion.

Design outcomes

Primary

MeasureTime frameDescription
Cardiac Output, Preload values (GEDV)Day 1 onlyOutcome measure is obtained during PiCCO measurement and left/right heart catherization, respectively (point-of-care measurement). There is no follow-up examination thereafter.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026