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

Edwards Lifesciences

Status: Completed

Conditions: Lung Water Assessment; Cardiac Output and Preload Assessment

Study type: Observational

Funder types: Industry

Identifiers

NCT01405040

MIM-0906-0001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

97 participants in 1 patient group

EV1000 Observational Group

Description:

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.