This pilot randomized controlled trial will evaluate whether catheter size affects the efficacy and performance of ultra-low-flow extracorporeal carbon dioxide removal (ECCO₂R) in mechanically ventilated adults with acute respiratory distress syndrome (ARDS) and hypercapnic respiratory acidosis. Participants will be randomly assigned to receive ECCO₂R using a 12F, 13F, or 15F catheter. The primary outcome is the percentage change in PaCO₂ from baseline during ECCO₂R. Secondary outcomes include achievement and time to correction of hypercapnic respiratory acidosis, changes in PaO₂, circuit lifespan, maximum blood flow, and device- and patient-related complications.
Age ≥18 years.
Acute respiratory distress syndrome (ARDS), mild to moderate severity, with a PaO₂/FiO₂ ratio of 100-300 while receiving PEEP ≥5 cmH₂O, after initiation of mechanical ventilation within the preceding 72 hours.
Driving pressure >15 cmH₂O;
Plateau pressure >27 cmH₂O;
Severe shock that is preload non-responsive and requires norepinephrine >1 µg/kg/min.
Acute brain injury or cerebral edema, increased intracranial pressure, status epilepticus, intracerebral hemorrhage, or acute ischemic stroke.
Pregnancy.
Morbid obesity with BMI >40 kg/m².
Single group
12F Catheter
DeviceParticipants randomized to receive ultra-low-flow extracorporeal carbon dioxide removal (ECCO₂R) using a 12 French (12F) catheter
13F Catheter
DeviceParticipants randomized to receive ultra-low-flow extracorporeal carbon dioxide removal (ECCO₂R) using a 13 French (13F) catheter
15F Catheter
DeviceParticipants randomized to receive ultra-low-flow extracorporeal carbon dioxide removal (ECCO₂R) using a 15 French (15F) catheter
Percentage Change in PaCO₂ From Baseline
Percentage change in arterial partial pressure of carbon dioxide (PaCO₂) from baseline after initiation of ultra-low-flow ECCO₂R. Unit of Measure: Percent (%)
Percentage of Participants Achieving Correction of Hypercapnic Respiratory Acidosis
Percentage of achievement (% of achievement) in resolving hypercapnic respiratory acidosis (PaCO2 \< 50 mmHg and pH\>7.30) from hour 0 in acute respiratory distress syndrome (ARDS) patients ventilated using a lung protective strategy with ECCO2R, evaluated for each catheter size at 1, 6, 12, 24, 48, and 72 hours.
Time to achievement (hours) in resolving hypercapnic respiratory acidosis
Time to achievement (hours) in resolving hypercapnic respiratory acidosis from hour 0 in acute respiratory distress syndrome (ARDS) patients ventilated using a lung protective strategy with ECCO2R, evaluated for each catheter size.
Change in PaO₂/FiO2 ratio From Baseline
Change in PaO₂/FiO2 ratio from baseline following initiation of ECCO₂R.
Circuit Lifespan
Duration of use of the ECCO₂R circuit from initiation until circuit replacement or discontinuation.
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