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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 20, 2011

Last Updated Date

April 1, 2013

Start Date ^ICMJE

January 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01405040 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Clinical Evaluation of a New Transpulmonary Thermodilution Method to Assess TPTD, GEDV and EVLW

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Cardiac Output and Preload Assessment
Lung Water Assessment

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany, Switzerland

Administrative Information

NCT Number ^ICMJE

NCT01405040

Other Study ID Numbers ^ICMJE

MIM-0906-0001

Has Data Monitoring Committee

Responsible Party

Edwards Lifesciences

Study Sponsor ^ICMJE

Edwards Lifesciences

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Dana Deyette, RN, CCRP

Edwards Lifesciences LLC

Information Provided By

Edwards Lifesciences

Verification Date

April 2013

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

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