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Table 2 Ongoing or completed clinical studies of ECCO2R in COPD

From: Extracorporeal carbon dioxide removal for acute hypercapnic respiratory failure

ClinicalTrials.gov number Title Type of study Hypothesis/primary outcome Estimated enrollment Device Status
ECCO2R to avoid mechanical ventilation
 NCT02564406 Extracorporeal CO2 removal in hypercapnic patients Interventional single-group trial Retrospectively assess the efficacy and safety of noninvasive ventilation-plus-extracorporeal CO2 removal in patients who fail NIV and refuse endotracheal intubation
Primary outcome: Number of patients who avoided endotracheal intubation
35 patients ProLUNG [Estor] Completed
 NCT03692117   Prospective cohort study Primary outcome: Incidence of avoiding endotracheal intubation 30 patients Not specified Recruiting
ECCO2R as an alternative or adjunct to invasive mechanical ventilation  
 NCT03255057 Extracorporeal CO2 removal for mechanical ventilation avoidance during acute exacerbation of COPD (VENT-AVOID) Multicenter randomized controlled trial ECCO2R can be safely used to avoid or reduce time on invasive mechanical ventilation compared to COPD patients treated with standard-of-care mechanical ventilation alone
Primary outcome: Ventilator-free days at day 60 from randomization
500 patients Hemolung Recruiting
ECCO2R physiological studies  
 NCT02586948 Physiological study of minimally invasive ECCO2R in exacerbations of COPD requiring invasive mechanical ventilation (EPHEBE) Interventional single-group trial The addition of minimally invasive ECCO2R is likely to limit dynamic hyperinflation in COPD patients requiring invasive mechanical ventilation for an acute exacerbation while improving gas exchange
Primary outcome: PEEPi at baseline and after ECCO2R by the device and adjustment of ventilator settings, expressed in cmH20
12 patients Hemolung Completed
 NCT02590575   Interventional single-group trial Test the effectiveness of a membrane gas exchange device in the veno-venous circulation of continuous renal replacement therapy for the purpose of CO2 elimination and pH compensation
The primary outcome is the modification of the PaCO2 and/or the ventilator settings (tidal volume VT and plateau pressure Pplat)
20 patients Prismalung Completed