Abstract
BackgroundNon-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.MethodsThe 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.ResultsAll 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.ConclusionThese in vivo results indicate positive performance of the Modular Extracorporeal Lung Assist System as a low-flow CO2 removal device.
Highlights
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
Extracorporeal CO2 removal (ECCO2R) devices provide a means to resolve the hypercapnia during lung-protective ventilation and in some instances allow extubation or non-invasive ventilation (NIV) [7,8,9,10,11]
We evaluated the 7-day in vivo performance of the adult lowflow ECCO2R Modular Extracorporeal Lung Assist System (ModELAS) in an awake ovine model
Summary
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. Mechanical ventilation (MV) is currently being used to normalize blood gas tensions in patients with acute respiratory distress syndrome (ARDS) or acute exacerbations of chronic obstructive pulmonary disease (ae-COPD). Reducing the airway pressures through non-invasive ventilation (NIV) or lung-protective ventilation techniques can improve patient outcomes; up to 25% of ae-COPD patients will fail NIV due to hypercapnia [3, 4]. The ongoing VENT-AVOID (NCT03255057) and REST (NCT02654327) randomized clinical trials aim to further expand the clinical evidence of using vv-ECCO2R as an alternative to invasive mechanical ventilation or in conjunction with low tidal volume ventilation, respectively
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