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For infants born at the border of viability, care practices and morbimortality rates vary widely between centers. Trends show significant improvement, however, with increasing gestational age and weight. For periviable infants, the goal of critical care is to bridge patients to improved outcomes. Current practice involves ventilator therapy, resulting in chronic lung injuries. Research has turned to artificial uterine environments, where infants are submerged in an artificial amniotic fluid bath and provided respiratory assistance via an artificial placenta. We have developed the Preemie-Ox, a hollow fiber membrane bundle that provides pumpless respiratory support via umbilical cord cannulation. Computational fluid dynamics was used to design an oxygenator that could achieve a carbon dioxide removal rate of 12.2 ml/min, an outlet hemoglobin saturation of 100%, and a resistance of less than 71 mmHg/L/min at a blood flow rate of 165 ml/min. A prototype was utilized to evaluate in-vitro gas exchange, resistance, and plasma-free hemoglobin generation. In-vitro gas exchange was 4% higher than predicted results and no quantifiable plasma-free hemoglobin was produced.

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The use of extracorporeal oxygenation and CO2 removal has gained clinical validity and popularity in recent years. These systems are composed of a pump to drive blood flow through the circuit and a hollow fiber membrane bundle through which gas exchange is achieved. Mathematical modeling of device design is utilized by researchers to improve device hemocompatibility and efficiency. A previously published mathematical model to predict CO2 removal in hollow fiber membrane bundles was modified to include an empirical representation of the Haldane effect. The predictive capabilities of both models were compared to experimental data gathered from a fiber bundle of 7.9 cm in length and 4.4 cm in diameter. The CO2 removal rate predictions of the model including the Haldane effect reduced the percent error between experimental data and mathematical predictions by up to 16%. Improving the predictive capabilities of computational fluid dynamics for the design of hollow fiber membrane bundles reduces the monetary and manpower expenses involved in designing and testing such devices.

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BACKGROUND: A wearable artificial lung could improve lung transplantation outcomes by easing implementation of physical rehabilitation during long-term pretransplant respiratory support. The Modular Extracorporeal Lung Assist System (ModELAS) is a compact pumping artificial lung currently under development. This study evaluated the long-term in vivo performance of the ModELAS during venovenous support in awake sheep. Feedback from early trials and computational fluid dynamic analysis guided device design optimization along the way. METHODS: The ModELAS was connected to healthy sheep via a dual-lumen cannula in the jugular vein. Sheep were housed in a fixed-tether pen while wearing the device in a holster during support. Targeted blood flow rate and support duration were 2-2.5 L/min and 28-30 days, respectively. Anticoagulation was maintained via systemic heparin. Device pumping and gas exchange performance and hematologic indicators of sheep physiology were measured throughout support. RESULTS: Computational fluid dynamic-guided design modifications successfully decreased pump thrombogenicity from initial designs. For the optimized design, 4 of 5 trials advancing past early perioperative and cannula-related complications lasted the full month of support. Blood flow rate and CO2 removal in these trials were 2.1 ± 0.3 L/min and 139 ± 15 mL/min, respectively, and were stable during support. One trial ended after 22 days of support due to intradevice thrombosis. Support was well tolerated by the sheep with no signs of hemolysis or device-related organ impairment. CONCLUSIONS: These results demonstrate the ability of the ModELAS to provide safe month-long support without consistent deterioration of pumping or gas exchange capabilities.

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Extracorporeal CO2 removal (ECCO2R) can permit lung protective or noninvasive ventilation strategies in patients with chronic obstructive pulmonary disease (COPD) and acute respiratory distress syndrome (ARDS). With evidence supporting ECCO2R growing, investigating factors which affect CO2 removal is necessary. Multiple factors are known to affect the CO2 removal rate (vCO2) which can complicate the interpretation of changes in vCO2; however, the effect of hematocrit on the vCO2 of artificial lungs has not been investigated. This in vitro study evaluates the relationship between hematocrit level and vCO2 within an ECCO2R device. In vitro gas transfer was measured in bovine blood in accordance with the ISO 7199 standard. Plasma and saline were used to hemodilute the blood to hematocrits between 33% and 8%. The vCO2 significantly decreased as the blood was hemodiluted with saline and plasma by 42% and 32%, respectively, between a hematocrit of 33% and 8%. The hemodilution method did not significantly affect the vCO2. In conclusion, the hematocrit level significantly affects vCO2 and should be taken into account when interpreting changes in the vCO2 of an ECCO2R device.

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