Validation of Peripheral Pressure Volume Loops and Ultrasound-derived "Cardiac Power" by Comparison With Invasive Left Ventricular Pressure Volume Loops
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|ClinicalTrials.gov Identifier: NCT01750450|
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : May 1, 2014
|Condition or disease|
Extensive animal work by Suga et al. in the 1980s clearly demonstrate a relationship between left ventricular pressure volume area (PVA) and myocardial consumption of oxygen (MVO2).
PVA can be measured by combining radial artery pressures with ultrasound-derived estimates of aortic blood flow. Because the aorta and peripheral artery compartments are separated from the left ventricle by the aortic valve, the peripheral arterial pressures cannot perfectly approximate left ventricular pressures. However, because the majority of variation in the pressure volume loops is made up of changes in height and width (changes in the left ventricular end-diastolic curve are, by contrast, relatively small), both of which can be readily detected by changes in the peripheral arterial blood pressure tracing, this loss of information may be clinically insignificant.
USCOM, has developed a portable suprasternal Doppler probe (model 1A) capable of estimating left ventricular stroke volume; a unique feature of this device is its ability to utilize both stroke volume, heart rate, and mean arterial pressure in an attempt to measure cardiac power. This device has not been validated against invasive estimates of cardiac power.
Knowledge of MVO2 would be a useful clinical variable but is not widely available. The ability to non-invasively estimate MVO2 intraoperatively would give anesthesiologists the ability to measure the effect of hemodynamic interventions on myocardial consumption of oxygen and, when combined with stroke volume, estimate myocardial efficiency. Non-invasively estimates of MVO2 may also allow cardiologists a novel means of assessing the myocardium of patients with cardiovascular disease.
|Study Type :||Observational|
|Actual Enrollment :||65 participants|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||June 2013|
Elective left heart cath
Patients undergoing elective left heart catheterization will be consented for this study
- Correlation between left ventricular pressure volume area (PVA) and aortic PVA [ Time Frame: day of procedure ]The primary hypothesis of this study is that the slope of the regression line between left ventricular pressure volume area (PVA, as determined by simultaneous measurement of aortic outflow and left ventricular pressures) and aortic PVA (as determined by simultaneous measurement of aortic outflow and radial artery pressure) is not zero. The null hypothesis is that the probability that the slope of the regression line is different from a line with a slope of 0 is greater than 5%.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750450
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|