Clinical evaluation of the Admiral 1.35m2 hollow-fibre membrane oxygenator

Abstract

This prospective study was designed to evaluate the fundamental clinical performance of a new, small surface area oxygenator. Data were collected from twenty patients undergoing first-time coronary artery bypass grafting using this device. This study focuses on how the reduction of surface area and prime volume affects the essential function of the oxygenator in terms of oxygenation efficiency, heat transference, membrane pressure drops, haemolysis and safety. Oxygenation efficiency was deemed to be well within acceptable margins, even at high flows, over a temperature range of 32-36°C. Heat-exchanger performance was assessed by recording the heater/chiller water temperature compared to retrospective data from a current standard oxygenator. Heater/chiller water temperatures were on average 0.3°C higher with the small surface oxygenator than the standard data. The air handling of the device was excellent and extremely safe. Haemolysis, measured as plasma free haemoglobin, did not increase during bypass (p>0.05). This new oxygenator offers a reduced surface area and priming volume while still ensuring an acceptable safety reserve and performance.