Status:
COMPLETED
Clinical Evaluation of a New Transpulmonary Thermodilution Method to Assess Thermodilution Cardiac Output, Global End Diastolic Volume and Extravascular Lung Water
Lead Sponsor:
Edwards Lifesciences
Conditions:
Cardiac Output and Preload Assessment
Lung Water Assessment
Eligibility:
All Genders
18+ years
Brief Summary
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.
Detailed Description
Transpulmonary thermodilution has been proposed to measure transpulmonary thermodilution cardiac output (TPTD), preload (GEDV, global end diastolic volume) and to quantify pulmonary edema (EVLW, extra...
Eligibility Criteria
Inclusion
- Patient must have clinical need for an indwelling femoral arterial catheter and central venous catheter.
- Patient, or legal guardian, must sign consent to be in the study prior to data capture.
- Patient must be at least 18 years old.
- Patient height and weight are available prior to study.
Exclusion
- Patients with significant aortic valve regurgitation.
- Patients being treated with an intra-aortic balloon pump.
- Patients less than 40 kg in weight.
- Female patients with a known pregnancy or planned pregnancy.
- Patient is currently participating in an investigational drug or another device study that clinically interferes with the study endpoints.
- Patients with peripheral vascular disease.
- Patients with aortic aneurysm.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT01405040
Start Date
January 1 2010
End Date
December 1 2010
Last Update
April 4 2013
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Universitätsklinikum der RWTH Aachen
Aachen, Pauwelsstrasse 30, Germany, 52074
2
Der Rheinischen Friedrich-Wilhelms-Universität Bonn
Bonn, Sigmund Freud Strasse 25, Germany, 53105
3
Stadtspital Triemli Zürich
Zurich, Birmensdorferstr 497, Switzerland, 8063
4
HUG-Hôpitaux Universitalres de Genève
Geneva, Canton of Geneva, Switzerland, 1211