A multi-center trial with a modified design of the Sarns membrane oxygenator.

A redesigned hollow fiber bundle was incorporated into an existing oxygenator that underwent clinical trials at seven cardiovascular surgery centers. Clinical investigators were asked to assess gas transfer performance under clinical conditions that could be considered challenging to any microporous membrane oxygenator, i.e., with large body weight patients, long bypass times, or normothermic bypass and surgery. Sixty-six patients, ranging in weight from 54.5 kg to 143 kg, constituted the initial evaluation population. Enhanced oxygen transfer was noted by all of the investigators. Fi0 2 requirements for patients weighing 100 kg or more never exceeded .85, despite oxygen consumption levels reaching as high as 396 mL/min. Two centers documented a 15% to 18% reduction in Fi0 2 requirements compared to their standard oxygenator.