Cardiac Output Pulmonary Arterial Catheter Compared to FloWave™ 1000

July 7, 2008 updated by: Woolsthorpe Technologies, LLC

Validation Study Comparing the Cardiac Output Pulmonary Arterial Catheter (Swan Ganz) to the FloWave™ 1000 Device

The purpose of this study is to compare cardiac output results obtained using the thermodilution push technique with the Pulmonary Arterial Catheter (PAC) to the predicted cardiac output results obtained from the non-invasive FloWave™ 1000 device.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • St. Thomas Hospital
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Heart Institute - St. Luke's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any patient that has a Swan Ganz PAC catheter in place.

Description

Inclusion Criteria:

  • Adults Only: The FloWave device is intended for use on adult patients only. All subjects will be 18 years or older.
  • Existing placement of a Pulmonary Arterial Catheter placed for medical reasons other than our study.

Exclusion Criteria:

  • Patients with aortic balloon pumps and cardiac mechanical assist devices will be excluded from study enrollment if the devices are present during the screening process. If patients have cardiac assist devices inserted after enrollment in the study, cardiac output data will be collected with both the PAC and FloWave device and will be evaluated as a subset analysis population at the conclusion of the study.
  • Patients with intracardiac shunts will be excluded from this study.
  • FloWave cardiac output determinations are dependent on detection of a pulse. If no peripheral pulse can be detected the device will not be able to perform a measurement and this will be indicated to the user.
  • Patients who are not in a steady hemodynamic state shall be excluded from the study.
  • Presence of arrhythmias: Patients with arrhythmias are excluded from the study when not in a steady hemodynamic state. If a patient has a history of arrhythmia or is currently experiencing an arrhythmia but is in a maintained hemodynamic state, they will not be excluded from enrollment into the study. Their clinical symptoms and cardiac rhythm will be evaluated and noted in the patient data record.
  • Inability or unwillingness of subject or the subject's legally authorized representative to give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation of FloWave 1000™ Device estimated cardiac output results with Pulmonary Catheter Themodilution Push derived cardiac output results.
Time Frame: Simultaneous data collection during procedure. No follow-up required.
Simultaneous data collection during procedure. No follow-up required.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Woolsthorpe Technologies, LLC

Investigators

  • Study Director: Jim M. Perry, M.D.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

April 21, 2008

First Submitted That Met QC Criteria

April 22, 2008

First Posted (ESTIMATE)

April 23, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 8, 2008

Last Update Submitted That Met QC Criteria

July 7, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WFW-019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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