Assessment of Hemodynamic Changes During Weaning From Mechanical Ventilation With Flo-Trac Vigileo (TM) Monitor.
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|ClinicalTrials.gov Identifier: NCT00631683|
Recruitment Status : Withdrawn (Terms for legal agreements between institution and Sponsor could not be made.)
First Posted : March 10, 2008
Last Update Posted : May 15, 2009
Failure to wean from mechanical ventilation (failure to get the patients off the breathing machine) is associated with prolonged stay in the intensive care unit and increased risk of death. Some patients have difficulty successfully getting off the ventilator and breathing on their own. Usually this difficulty is due to lung problems. But sometimes it is due to heart problems, or heart failure. To improve a patient's chances of successfully getting off the ventilator early, it is helpful to the doctors to know if patient has heart failure and to measure how severe. With the new monitoring system being studied here, doctors may be able to detect and measure heart failure more easily.
A new monitor (Vigileo TM) that is connected with a specific cable (Flo-TracTM) to a catheter that is inside the patient's artery (arterial line) has lately been developed. This monitor can estimate the amount of blood that the heart is pumping per minute, known as cardiac output. The heart is supposed to pump blood harder when a patient is being weaned from the breathing machine. With the above mentioned monitor, we hope to detect those patients whose hearts are weak and are not pumping as hard as they should.
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Use of Flo-Trac/Vigileo (TM) for Hemodynamic Monitoring During Discontinuation From Mechanical Ventilation|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||February 2008|
|Estimated Study Completion Date :||February 2008|
Mechanically ventilated patients who are about to start a weaning trial at the medical intensive care unit of Memorial Hermann Hospital.
- To describe the hemodynamic changes during the process of discontinuation from mechanical ventilation with the aid of Flo-Trac/Vigileo (TM) [ Time Frame: 2 and 9 months ]
- To compare the hemodynamic changes between patients who had successful and those who had unsuccessful discontinuation from mechanical ventilation [ Time Frame: 2 and 9 months ]
- To determine if the lack of increase in cardiac output during discontinuation from mechanical ventilation is associated with and predictive of weaning failure [ Time Frame: 2 and 9 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00631683
|United States, Texas|
|Memorial Hermann Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Roberto F Casal, MD||The University of Texas Health Science Center, Houston|