Abstract

In August 2006, Duke University Perfusion Services had the opportunity to be the first institution in the United States to clinically evaluate the Dideco D100 Neonatal Oxygenator. The device was used on six pediatric patients to facilitate correction or palliation of their cardiac defects, which included two arterial switch operations, two truncus arteriosus repairs, one stage 1 Norwood and one repair of total anomalous pulmonary venous return. The average patient weight was 3.1 kg. The average cardiopulmonary bypass (CPB) time was 135 minutes and the average cross-clamp time was 61 minutes. Arterial and venous blood gasses were drawn and used to calculate oxygen transfer. The average oxygen transfer was 14.8 +/- 10.3 ml/O2/min. The Dideco D100 Oxygenator is the first oxygenation device designed specifically for neonates. The Dideco D100 is a microporous hollow-fiber device. It has a static priming volume of 31 ml and a maximum rated flow of 700 ml/min. The integral hard-shell venous reservoir has a minimum operating level of 10 ml and a reservoir capacity of 500 ml. For this evaluation, the Dideco Kids D100 Neonatal Oxygenator performed adequately on patients weighing up to 5 kg. This device provides an excellent first step towards offering very small children appropriate circuitry without having to sacrifice safety or performance.

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