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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