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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiac Output and Preload Assessment, Lung Water Assessment

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must have clinical need for an indwelling femoral arterial catheter and central venous catheter. Patient, or legal guardian, must sign consent to be in the study prior to data capture. Patient must be at least 18 years old. Patient height and weight are available prior to study. Exclusion Criteria: Patients with significant aortic valve regurgitation. Patients being treated with an intra-aortic balloon pump. Patients less than 40 kg in weight. Female patients with a known pregnancy or planned pregnancy. Patient is currently participating in an investigational drug or another device study that clinically interferes with the study endpoints. Patients with peripheral vascular disease. Patients with aortic aneurysm.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EV1000 Observational Group<br>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?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac, Output, Preload, Lung, Water