Clinical Evaluation of a New Transpulmonary Thermodilution Method to Assess Thermodilution Cardiac Output, Global End Diastolic Volume and Extravascular Lung Water
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.
Cardiac Output and Preload Assessment
Lung Water Assessment
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Clinical Evaluation of a New Transpulmonary Thermodilution Method to Assess TPTD, GEDV and EVLW|
- TPTD, GEDV and EVLW measurements to evaluate the precision and accuracy of a novel algorithm in comparison to the widely accepted TPTD method [ Time Frame: Up to 72 hours of femoral arterial catheter dwell time. ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2010|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01405040
|Universitätsklinikum der RWTH Aachen|
|Aachen, Pauwelsstrasse 30, Germany, 52074|
|Der Rheinischen Friedrich-Wilhelms-Universität Bonn|
|Bonn, Sigmund Freud Strasse 25, Germany, 53105|
|Stadtspital Triemli Zürich|
|Zürich, Birmensdorferstr 497, Switzerland, 8063|
|HUG-Hôpitaux Universitalres de Genève|
|Genève, Geneva, Switzerland, 1211|
|Study Director:||Dana Deyette, RN, CCRP||Edwards Lifesciences LLC|