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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01405040
First received: July 20, 2011
Last updated: April 1, 2013
Last verified: April 2013
  Purpose

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.


Condition
Cardiac Output and Preload Assessment
Lung Water Assessment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation of a New Transpulmonary Thermodilution Method to Assess TPTD, GEDV and EVLW

Resource links provided by NLM:


Further study details as provided by Edwards Lifesciences:

Primary Outcome Measures:
  • TPTD, GEDV and EVLW measurements to evaluate the precision and accuracy of a novel algorithm in comparison to the widely accepted TPTD method [ Time Frame: Up to 72 hours of femoral arterial catheter dwell time. ] [ Designated as safety issue: No ]
    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.


Enrollment: 97
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405040

Locations
Germany
Universitätsklinikum der RWTH Aachen
Aachen, Pauwelsstrasse 30, Germany, 52074
Der Rheinischen Friedrich-Wilhelms-Universität Bonn
Bonn, Sigmund Freud Strasse 25, Germany, 53105
Switzerland
Stadtspital Triemli Zürich
Zürich, Birmensdorferstr 497, Switzerland, 8063
HUG-Hôpitaux Universitalres de Genève
Genève, Geneva, Switzerland, 1211
Sponsors and Collaborators
Edwards Lifesciences
Investigators
Study Director: Dana Deyette, RN, CCRP Edwards Lifesciences LLC
  More Information

Additional Information:
No publications provided by Edwards Lifesciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01405040     History of Changes
Other Study ID Numbers: MIM-0906-0001
Study First Received: July 20, 2011
Last Updated: April 1, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Edwards Lifesciences:
Cardiac
Output
Preload
Lung
Water

ClinicalTrials.gov processed this record on July 22, 2014