Minimally Invasive Cardiac Output Monitoring Device
This trial is active, not recruiting.
|Treatment||retia non-invasive sensors|
|Sponsor||University of Michigan|
|Start date||August 2012|
|End date||October 2015|
|Trial size||75 participants|
|Trial identifier||NCT01675063, UM HUM 63973|
The overall goal of this collaborative study is to advance the novel "pulse contour analysis" to the point at which it can be incorporated into a real-time device. The specific objective is to establish an auto-calibration algorithm that conveniently yields cardiac output (CO) in units of liters-per-minute. To achieve this objective, the waveforms for analysis and reference pulmonary artery catheter CO measurements will be recorded from critically ill patients and then analyzed off-line at Retia Medical. Successful completion of this study may ultimately help lead to improved outcomes of critically ill patients.
|Intervention model||single group assignment|
Establishment of an auto-calibration algorithm to measure cardiac output
time frame: 8 hours post cardiac surgery
Male or female participants at least 18 years old.
Inclusion Criteria: - All adult patients admitted to the University of Michigan ICU following cardiac surgery with both a pulmonary and radial artery catheter. Exclusion Criteria: - Adult patients with mechanical cardiac support including intra-aortic balloon pumps, LVAD, or ECMO, and persistent ventricular arrhythmias.
|Official title||Development of a Minimally Invasive Cardiac Output Monitoring Device for Critically Ill Patients|
|Principal investigator||James M Blum, MD|
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