Clinical Evaluation of a New Transpulmonary Thermodilution Method to Assess Thermodilution Cardiac Output, Global End Diastolic Volume and Extravascular Lung Water
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01405040|
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : April 4, 2013
|Condition or disease|
|Cardiac Output and Preload Assessment Lung Water Assessment|
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.
|Study Type :||Observational|
|Actual Enrollment :||97 participants|
|Official Title:||Clinical Evaluation of a New Transpulmonary Thermodilution Method to Assess TPTD, GEDV and EVLW|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
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.
- 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. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|