Extracorporeal Carbon Dioxide Removal Plus Noninvasive Ventilation in Patients With COPD Not Eligible for Intubation

Overview

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.

Acute exacerbations of chronic obstructive pulmonary disease (COPD) may cause severe hypercapnic respiratory failure. Noninvasive ventilation (NIV) is the standard initial respiratory support, but some patients have persistent respiratory acidosis despite NIV. Treatment options are particularly limited when invasive mechanical ventilation is not considered appropriate or is declined by the patient. Extracorporeal carbon dioxide removal (ECCO2R) uses a low-flow extracorporeal circuit to remove carbon dioxide directly from the blood. When used together with NIV, ECCO2R may reduce the ventilatory demand and work of breathing, improve respiratory acidosis, and facilitate earlier withdrawal of NIV. This single-center, open-label, randomized proof-of-concept trial will compare NIV plus ECCO2R with NIV alone in patients with an acute exacerbation of COPD and persistent hypercapnic respiratory acidosis after 4 hours of NIV. The study is intended to provide preliminary evidence regarding the physiological effects, clinical feasibility, and safety of adding ECCO2R to standard NIV in this highly selected population. The findings may inform the design of larger clinical trials.