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

Cardiac Output and Preload Assessment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01405040
• Other study ID #: MIM-0906-0001
• Status: Completed
• Phase: N/A
• First received: July 20, 2011
• Last updated: April 1, 2013
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: April 2013
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Output and Preload Assessment
• Lung Water Assessment

Locations

Country	Name	City	State
Germany	Universitätsklinikum der RWTH Aachen	Aachen	Pauwelsstrasse 30
Germany	Der Rheinischen Friedrich-Wilhelms-Universität Bonn	Bonn	Sigmund Freud Strasse 25
Switzerland	HUG-Hôpitaux Universitalres de Genève	Genève	Geneva
Switzerland	Stadtspital Triemli Zürich	Zürich	Birmensdorferstr 497

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TPTD, GEDV and EVLW measurements to evaluate the precision and accuracy of a novel algorithm in comparison to the widely accepted TPTD method	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.	Up to 72 hours of femoral arterial catheter dwell time.	No

External Links

•   Study Results - Clinical validation of a new thermo dilution system for the assessment of cardiac output and volumetric parameters