Non-invasive and lung-protective ventilation techniques may improve outcomes for patients with an acute exacerbation of chronic obstructive pulmonary disease or moderate acute respiratory distress syndrome by reducing airway pressures. These less invasive techniques can fail due to hypercapnia and require transitioning patients to invasive mechanical ventilation. Extracorporeal CO2 removal devices remove CO2 independent of the lungs thereby controlling the hypercapnia and permitting non-invasive or lung-protective ventilation techniques. We are developing the Modular Extracorporeal Lung Assist System as a platform technology capable of providing three levels of respiratory assist: adult and pediatric full respiratory support and adult low-flow CO2 removal. The objective of this study was to evaluate the in vivo performance of our device to achieve low-flow CO2 removal. The Modular Extracorporeal Lung Assist System was connected to 6 healthy sheep via a 15.5 Fr dual-lumen catheter placed in the external jugular vein. The animals were recovered and tethered within a pen while supported by the device for 7 days. The pump speed was set to achieve a targeted blood flow of 500 mL/min. The extracorporeal CO2 removal rate was measured daily at a sweep gas independent regime. Hematological parameters were measured pre-operatively and regularly throughout the study. Histopathological samples of the end organs were taken at the end of each study. All animals survived the surgery and generally tolerated the device well. One animal required early termination due to a pulmonary embolism. Intra-device thrombus formation occurred in a single animal due to improper anticoagulation. The average CO2 removal rate (normalized to an inlet pCO2 of 45 mmHg) was 75.6 ± 4.7 mL/min and did not significantly change over the course of the study (p > 0.05). No signs of consistent hemolysis or end organ damage were observed. These in vivo results indicate positive performance of the Modular Extracorporeal Lung Assist System as a low-flow CO2 removal device.

中文翻译：

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紧凑型平台呼吸装置低流量二氧化碳去除应用的体内测试


无创和肺保护性通气技术可以通过降低气道压力来改善慢性阻塞性肺疾病急性加重或中度急性呼吸窘迫综合征患者的预后。这些微创技术可能会因高碳酸血症而失败，并需要将患者过渡到有创机械通气。体外二氧化碳去除装置独立于肺部去除二氧化碳，从而控制高碳酸血症并允许无创或肺保护性通气技术。我们正在开发模块化体外肺辅助系统作为一种平台技术，能够提供三个级别的呼吸辅助：成人和儿童全面呼吸支持以及成人低流量二氧化碳去除。本研究的目的是评估我们的装置实现低流量二氧化碳去除的体内性能。模块化体外肺辅助系统通过放置在颈外静脉中的 15.5 Fr 双腔导管连接到 6 只健康羊。动物被回收并拴在围栏内，并由该装置支撑 7 天。泵速设置为实现 500 mL/min 的目标血流量。每天在不依赖于吹扫气体的情况下测量体外二氧化碳去除率。在术前和整个研究过程中定期测量血液学参数。在每项研究结束时采集终末器官的组织病理学样本。所有动物均在手术中存活下来，并且通常对该装置的耐受性良好。一只动物因肺栓塞而需要提前终止。由于抗凝不当，单个动物体内发生了装置内血栓形成。平均 CO2 去除率（标准化为入口 pCO2 为 45 mmHg）为 75.6 ± 4。7 mL/min，并且在研究过程中没有显着变化 (p > 0.05)。没有观察到持续溶血或终末器官损伤的迹象。这些体内结果表明模块化体外肺辅助系统作为低流量二氧化碳去除装置的积极性能。