The Safety and Performance of a Novel Extracorporeal Membrane Oxygenation Device in a Long-Term Ovine Model.

Abstract

Since extracorporeal membrane oxygenation (ECMO) is primarily used for patients in a high-risk state and is an invasive procedure, its unique application scenarios make it difficult to recruit suitable cases for clinical trials. Therefore, large animal models have become one of the most important models for preclinical evaluation of the safety and effectiveness of ECMO. This study aims to assess the safety and performance of a novel portable ECMO device with Small-tail Han sheep. Fifteen sheep were divided into a test group (LIFEMOTION, Chinabridge, Shenzhen, China) and control group (NOVALUNG XLUNG kit 230, Xonis, Heilbronn, Germany) with veno-venous ECMO (VV-ECMO) and veno-arterial ECMO (VA-ECMO) modes. Tracheal intubation, arteriovenous access, and ECMO support were performed. Vital signs and blood laboratory tests of the subjects were monitored and recorded. The main organs were examined pathologically at the end of day fourteen. The serum protein expression profile was analyzed by protein quantification techniques. All sheep were successfully weaned from ECMO without transfusion or cannula complications. No significant differences were observed between the two groups in terms of vital signs, oxygenation, hemodynamic stability, and physiological function (p > 0.05). According to the serum protein expression profile, no significant biomarkers associated with ECMO clinical complications were identified. The LIFEMOTION ECMO device demonstrated good safety and efficacy.