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

NCT01405040 | Completed

• 1 other identifier: MIM-0906-0001
• Study Type: observational
• Target: 97
• Locations: 2 countries
• Sites: 4

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.

Conditions

Cardiac Output and Preload Assessment; Lung Water Assessment

Keywords

Cardiac; Output; Preload; Lung; Water

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (4)

Universitätsklinikum der RWTH Aachen

Aachen, Pauwelsstrasse 30, 52074, Germany

Location

Der Rheinischen Friedrich-Wilhelms-Universität Bonn

Bonn, Sigmund Freud Strasse 25, 53105, Germany

Location

Stadtspital Triemli Zürich

Zurich, Birmensdorferstr 497, 8063, Switzerland

Location

HUG-Hôpitaux Universitalres de Genève

Geneva, Canton of Geneva, 1211, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 23625132 DERIVED

• Kiefer N, Hofer CK, Marx G, Geisen M, Giraud R, Siegenthaler N, Hoeft A, Bendjelid K, Rex S. Clinical validation of a new thermodilution system for the assessment of cardiac output and volumetric parameters. Crit Care. 2012 May 30;16(3):R98. doi: 10.1186/cc11366.

  PMID: 22647561 DERIVED

Study Officials

• Dana Deyette, RN, CCRP

  Edwards Lifesciences LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: July 29, 2011
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 4, 2013

Record last verified: 2013-04

Locations

DE (2); CH (2)