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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

Study Locations

• Germany
  • Pauwelsstrasse 30
    • Aachen, Pauwelsstrasse 30, Germany, 52074
      • Universitatsklinikum der RWTH Aachen
  • Sigmund Freud Strasse 25
    • Bonn, Sigmund Freud Strasse 25, Germany, 53105
      • Der Rheinischen Friedrich-Wilhelms-Universität Bonn
• Switzerland
  • Birmensdorferstr 497
    • Zürich, Birmensdorferstr 497, Switzerland, 8063
      • Stadtspital Triemli Zürich
  • Geneva
    • Genève, Geneva, Switzerland, 1211
      • HUG-Hôpitaux Universitalres de Genève

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will include all ICU patients requiring cardiac preload and lung water assessment.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Study Director: Dana Deyette, RN, CCRP, Edwards Lifesciences LLC

Publications and helpful links

General Publications

• Bendjelid K, Marx G, Kiefer N, Simon TP, Geisen M, Hoeft A, Siegenthaler N, Hofer CK. Performance of a new pulse contour method for continuous cardiac output monitoring: validation in critically ill patients. Br J Anaesth. 2013 Oct;111(4):573-9. doi: 10.1093/bja/aet116. Epub 2013 Apr 26.
• Kiefer N, Hofer CK, Marx G, Geisen M, Giraud R, Siegenthaler N, Hoeft A, Bendjelid K, Rex S. Clinical validation of a new thermodilution system for the assessment of cardiac output and volumetric parameters. Crit Care. 2012 May 30;16(3):R98. doi: 10.1186/cc11366.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: July 20, 2011
• First Submitted That Met QC Criteria: July 28, 2011
• First Posted (ESTIMATE): July 29, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): April 4, 2013
• Last Update Submitted That Met QC Criteria: April 1, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Lung; Cardiac; Water; Preload; Output
• Other Study ID Numbers: MIM-0906-0001