Continuous Cardiac Output Determination

Thermal dilution, the most common method used for determining cardiac output, is highlytechnique dependant and yields results that may be off as much as +/- 2O%. To reduce error, theprocedure is often repeated a number of times and the average of all of the readings taken. Each readingrequires a bolus injection of solution, increasing the risk of sepsis and fluid overload. Modifications tothis technique using intravascular heating elements as the thermal indicator offer nearly continuousreadings but no better accuracy. A continuous cardiac output catheter will use the arterial pressure tocalculate cardiac output. The significant difference to the approach described is a method by which thesystem may be calibrated without injection of any sort of indicator. As a result, the calibration may berepeated as often as desired with no adverse effect to the patient. The phase I studies are designed toconclusively demonstrate the feasibility of the calibration method first using a mock circulation and thana number of animal experiments to validate the data. Phase II would be directed towards productdevelopment and FDA clearance for the device.