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The primary objective of this study is to obtain the TPTD, GEDV and EVLW measurements from existing indwelling femoral arterial Volume View™ catheter and central venous catheters.
Transpulmonary thermodilution has been proposed to measure transpulmonary thermodilution cardiac output (TPTD), preload (GEDV, global end diastolic volume) and to quantify pulmonary edema (EVLW, extravascular lung water). The method currently available on the market is based on the estimation of time characteristics of the curve (mean transit time and down slope time).
The purpose of this study is to evaluate a new transpulmonary thermodilution method to assess the TPTD, EVLW and GEDV in patients requiring cardiac preload and lung water assessment. Up to one hundred (100) patients will be enrolled at four (4) study sites, (up to 25 subjects at each site). Hôpitaux Universitaires de Genève, Universität Bonn, Stadtspital Triemli Zürich, and Universitätsklinikum Aachen will participate in the study.
This is a prospective, observational data collection study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EV1000 Observational Group | Patient must have an indwelling femoral arterial catheter and central venous catheter considered necessary for routine clinical monitoring; Patient, or legal guardian, will give consent prior to study enrollment and data capture; Patient must be at least 18 years old; Patient height and weight are available prior to study. |
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| Measure | Description | Time Frame |
|---|---|---|
| TPTD, GEDV and EVLW measurements to evaluate the precision and accuracy of a novel algorithm in comparison to the widely accepted TPTD method | This is not an outcome study. This is an observational Study to obtain TPTD, GEDV and EVLW data to evaluate the precision and accuracy of a novel algorithm in comparison to the widely accepted TPTD method using an approach defined by Bland-Altman. | Up to 72 hours of femoral arterial catheter dwell time. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include all ICU patients requiring cardiac preload and lung water assessment.
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| Name | Affiliation | Role |
|---|---|---|
| Dana Deyette, RN, CCRP | Edwards Lifesciences LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum der RWTH Aachen | Aachen | Pauwelsstrasse 30 | 52074 | Germany | ||
| Der Rheinischen Friedrich-Wilhelms-Universität Bonn |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23625132 | Derived | Bendjelid K, Marx G, Kiefer N, Simon TP, Geisen M, Hoeft A, Siegenthaler N, Hofer CK. Performance of a new pulse contour method for continuous cardiac output monitoring: validation in critically ill patients. Br J Anaesth. 2013 Oct;111(4):573-9. doi: 10.1093/bja/aet116. Epub 2013 Apr 26. | |
| 22647561 | Derived |
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| Bonn |
| Sigmund Freud Strasse 25 |
| 53105 |
| Germany |
| Stadtspital Triemli Zürich | Zurich | Birmensdorferstr 497 | 8063 | Switzerland |
| HUG-Hôpitaux Universitalres de Genève | Geneva | Canton of Geneva | 1211 | Switzerland |
| Kiefer N, Hofer CK, Marx G, Geisen M, Giraud R, Siegenthaler N, Hoeft A, Bendjelid K, Rex S. Clinical validation of a new thermodilution system for the assessment of cardiac output and volumetric parameters. Crit Care. 2012 May 30;16(3):R98. doi: 10.1186/cc11366. |