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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01405040

Enrollment

Registered

2011-07-29

Start date

2010-01-31

Completion date

2010-12-31

Last updated

2013-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Output and Preload Assessment, Lung Water Assessment

Keywords

Cardiac, Output, Preload, Lung, Water

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
TPTD, GEDV and EVLW measurements to evaluate the precision and accuracy of a novel algorithm in comparison to the widely accepted TPTD method	Up to 72 hours of femoral arterial catheter dwell time.	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.

Countries

Germany, Switzerland

Outcome results