Original Article

Clinical Trials of a New Infant Membrane Oxygenator

Division of Cardiothoracic Surgery and the Department of Extracorporeal Circulation Technology, College of Health Related Professions, Medical University of South Carolina, Charleston, SC

^* Address correspondence to: Jonathan H. Merrill, Department of Extracorporeal Circulation Technology, College of Health Related Professions, Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC 29415.

Abstract

Clinical trials of a new infant/pediatric hollow fiber membrane oxygenator were performed at the Medical University of South Carolina with parental consent. The oxygenator has a static priming volume of 170 ml with a rated blood flow of 2.5 1/min. Circuit priming volumes ranged from 800 to 1000 ml. The oxygenator was used on 15 infant/pediatric patients ranging from five days to 10.4 years of age, with BSAs of 0.2 to 1.01 m².

Results show no significant differences in plasma-free hemoglobin or platelet counts between pre-op and fourth day postop. Statistical analysis of the clinical data were used to produce theoretical (TH) and clinical (CL) multiple linear regression equations which enable the perfusionist to predict the minimal FiO₂ and gas flow (GF) for desired PaO₂ and alpha stat PaCO₂.

TH-FiO₂ TH-GF CL-FiO₂ CL-GF

r=.91 r=.80 r=.89 r=.79

(p < 0.0001 for all values)

This oxygenator can be safely used for a relatively large range (3 to 25 kg) of infant and pediatric patients with statistically predictable results.