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

July 20, 2011
April 1, 2013
January 2010
December 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01405040 on ClinicalTrials.gov Archive Site
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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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

  • Cardiac Output and Preload Assessment
  • Lung Water Assessment
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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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Switzerland
 
NCT01405040
MIM-0906-0001
No
Edwards Lifesciences
Edwards Lifesciences
Not Provided
Study Director: Dana Deyette, RN, CCRP Edwards Lifesciences LLC
Edwards Lifesciences
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP