Clinical evaluation of a new generation membrane oxygenator: a prospective randomized study.

A new generation hollow-fibre membrane oxygenator (Spiral Gold) has been introduced by Baxter Healthcare (Irvine, CA, USA). The purpose of this study was to evaluate the operational performance of this device under clinical conditions and to compare it to the Univox Gold membrane oxygenator. Following institutional review board approval, and the obtainment of informed consent, 26 patients undergoing coronary artery bypass grafting were randomly assigned to either a Spiral Gold (Spiral) (n = 13) or Univox Gold (Univox) (n = 13) group. Study parameters were grouped into the following categories: haematological, haemodynamic, oxygenator performance and perioperative outcomes. All patients received identical surgical, anaesthesia and postoperative care. There were no statistically significant differences in either preoperative or operative parameters between groups. During cardiopulmonary bypass, the Spiral group had a significantly lower pressure drop (26.9 +/- 8.2 vs 46.7 +/- 16.2 mmHg, p < 0.001). The Spiral group had significantly lower plasma free haemoglobin levels during all time periods of CPB compared to the Univox group. Heat exchange coefficients were higher during the rewarming period in the Spiral patients (0.59 +/- 0.28) compared to the Univox group (0.36 +/- 0.19), p = 0.06. There were no differences in oxygen transfer between groups, but ventilation gas sweep rates and FiO2 levels were statistically lower in the Spiral group at two of the three sampling time periods. The ratio of ventilating gas sweep rate to blood flow rate was lower in the Spiral group (0.56 +/- 0.12) compared to the Univox group (0.74 +/- 0.23), p < 0.03. The Spiral Gold oxygenator had superior oxygen transfer efficiency and lower haemolysis rates than the Univox Gold oxygenator.