Clinical trial NCT01405040: Clinical Evaluation of a New Transpulmonary Thermodilution Method to Assess Thermodilution Cardiac Output, Global End Diastolic Volume and Extravascular Lung Water
Official title: Clinical Evaluation of a New Transpulmonary Thermodilution Method to Assess TPTD, GEDV and EVLW
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Output and Preload Assessment
Lung Water Assessment
Keywords: Cardiac
Output
Preload
Lung
Water
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2011-07-29
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include all ICU patients requiring cardiac preload and lung water assessment.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: TPTD, GEDV and EVLW measurements to evaluate the precision and accuracy of a novel algorithm in comparison to the widely accepted TPTD method
timeFrame: Up to 72 hours of femoral arterial catheter dwell time.
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universitätsklinikum der RWTH Aachen
state: Pauwelsstrasse 30
city: Bonn
country: Germany
facility: Der Rheinischen Friedrich-Wilhelms-Universität Bonn
state: Sigmund Freud Strasse 25
city: Zürich
country: Switzerland
facility: Stadtspital Triemli Zürich
state: Birmensdorferstr 497
city: Genève
country: Switzerland
facility: HUG-Hôpitaux Universitalres de Genève
state: Geneva
Study officials:
affiliation: Edwards Lifesciences LLC
name: Dana Deyette, RN, CCRP
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.