This study will evaluate whether adding extracorporeal carbon dioxide removal (ECCO2R) to noninvasive ventilation can improve breathing in adults hospitalized with a severe worsening of chronic obstructive pulmonary disease (COPD). Participants will have high carbon dioxide levels and increased acidity in their blood despite treatment with noninvasive ventilation and will not be eligible for invasive mechanical ventilation through a breathing tube.
A total of 14 participants will be assigned by chance to receive either noninvasive ventilation alone or noninvasive ventilation together with ECCO2R. ECCO2R removes carbon dioxide directly from the blood through a catheter placed in a large vein. The main aim is to determine whether adding ECCO2R reduces the breathing rate within 4 hours. The study will also assess blood carbon dioxide and acidity, duration of noninvasive ventilation, length of hospital stay, survival, and complications related to ECCO2R.
Age 18 years or older.
Confirmed diagnosis of chronic obstructive pulmonary disease (COPD).
Acute exacerbation of COPD, defined as increased dyspnea, cough, and/or sputum production.
Acute hypercapnic respiratory failure requiring noninvasive ventilation, with arterial pH <7.30 and PaCO2 >50 mmHg.
Contraindication to extracorporeal carbon dioxide removal due to a coagulation disorder.
Inability to establish adequate vascular access.
Parallel
Extracorporeal Carbon Dioxide Removal
DeviceLow-flow extracorporeal carbon dioxide removal will be provided using the Prismalung+ membrane connected to the PrisMax 2 system. Treatment will be initiated within 12 hours after randomization through a 13- to 14-Fr double-lumen venous catheter. The initial sweep gas flow will be 10 L/min, and blood flow will be set as high as tolerated by the system, with a target of approximately 450 mL/min. Treatment settings will be adjusted according to carbon dioxide removal and arterial pH.
Noninvasive Ventilation
DeviceNoninvasive ventilation will be delivered according to current clinical guidelines and usual clinical practice. Ventilator settings and duration of treatment will be adjusted by the treating clinical team according to the participant's respiratory status and clinical response.
Change in Respiratory Rate From Baseline to 4 Hours
Change in respiratory rate, measured in breaths per minute, from the study baseline to 4 hours after initiation of ECCO2R in the experimental arm or the corresponding study time point in the control arm. A negative value indicates a reduction in respiratory rate.
Change in Arterial Carbon Dioxide Pressure
Change in arterial partial pressure of carbon dioxide (PaCO2), measured in mmHg, from baseline to 4 hours after initiation of the assigned treatment.
Change in Arterial pH
Change in arterial blood pH from baseline to 4 hours after initiation of the assigned treatment.
Duration of Noninvasive Ventilation
Total duration of noninvasive ventilation, measured in hours, from initiation until permanent discontinuation during the index hospitalization.
Hospital Length of Stay
Number of days from hospital admission to hospital discharge or in-hospital death.
Intensive Care Unit Length of Stay
Number of days from intensive care unit admission to intensive care unit discharge or death in the intensive care unit.
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