NCT01405040

Clinical Evaluation of a New Transpulmonary Thermodilution Method to Assess Thermodilution Cardiac Output, Global End Diastolic Volume and Extravascular Lung Water

Clinical Evaluation of a New Transpulmonary Thermodilution Method to Assess TPTD, GEDV and EVLW

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 97 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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, 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.

Conditions

• Cardiac Output and Preload Assessment
• Lung Water Assessment

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2011-07-29
• Last updated: 2013-04-04

Locations

4 sites across 2 countries: Germany, Switzerland