Cardiac Output Pulmonary Arterial Catheter Compared to FloWave™ 1000

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.

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Key information

Conditions

Congestive Heart Failure Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Failure Heart Valve Diseases Heart Valve Prolapse Ischemic Cardiomyopathy Mitral Regurgitation Mitral Valve Insufficiency Mitral Valve Prolapse Tricuspid Regurgitation Tricuspid Valve Insufficiency

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Thomas Hospital, Nashville, Tennessee, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Woolsthorpe Technologies, LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Apr 23, 2008
Registry last updated: Jul 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed