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

Completed

• Conditions: Cardiac Output and Preload Assessment; Lung Water Assessment

• Registration Number: NCT01405040
• Lead Sponsor: Edwards Lifesciences

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, 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 Timeline

• Study Start: 2010-01
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2011-07-20
• Study First Submitted QC: 2011-07-28
• Study First Posted: 2011-07-29
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-01
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

1. Patient must have clinical need for an indwelling femoral arterial catheter and central venous catheter.
2. Patient, or legal guardian, must sign consent to be in the study prior to data capture.
3. Patient must be at least 18 years old.
4. Patient height and weight are available prior to study.

Exclusion Criteria

1. Patients with significant aortic valve regurgitation.
2. Patients being treated with an intra-aortic balloon pump.
3. Patients less than 40 kg in weight.
4. Female patients with a known pregnancy or planned pregnancy.
5. Patient is currently participating in an investigational drug or another device study that clinically interferes with the study endpoints.
6. Patients with peripheral vascular disease.
7. Patients with aortic aneurysm.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TPTD, GEDV and EVLW measurements to evaluate the precision and accuracy of a novel algorithm in comparison to the widely accepted TPTD method	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.

Trial Locations

Locations (4)

Universitätsklinikum der RWTH Aachen; 🇩🇪 Aachen, Pauwelsstrasse 30, Germany

Stadtspital Triemli Zürich; 🇨🇭 Zürich, Birmensdorferstr 497, Switzerland

Der Rheinischen Friedrich-Wilhelms-Universität Bonn; 🇩🇪 Bonn, Sigmund Freud Strasse 25, Germany

HUG-Hôpitaux Universitalres de Genève; 🇨🇭 Genève, Geneva, Switzerland