A prospective clinical evaluation of new ECCO2R technology in mild to moderate ARDS patients: assessing ultra-lung-protective ventilation with PRISMALUNG+

Abstract

Background: Extracorporeal carbon dioxide removal (ECCO2R), when used as an adjunct to mechanical ventilation in patients with mild to moderate acute respiratory distress syndrome (ARDS), has been proposed as a strategy to control hypercapnic acidosis during ultra-lung-protective ventilation (ULPV). However, no multicenter study has systematically assessed ventilation improvement markers with a standardized protocol using ECCO₂R devices featuring a peristaltic pump design. This prospective, multicenter study conducted in France addresses these gaps by evaluating the performance and safety of PRISMALUNG+, a novel membrane lung specifically developed for ECCO2R, either as a standalone therapy or combined with continuous renal replacement therapy (CRRT). A specific protocol for ULPV was used to minimize lung stress and mitigate the risk of hypoxemia. Methods: Between April 2021 and December 2023, 58 patients were treated with ECCO2R (16 in combination with CRRT). Tidal volume (VT) was reduced stepwise from 6 mL/kg to 4 mL/kg. Once the partial pressure of carbon dioxide (PaCO2) exceeded 50 mmHg, sweep gas (100% oxygen at 10 L/min) was initiated to provide ECCO2R. Outcomes were measured at 8 and 24 h, while safety was monitored until discharge or day 28. Results: During VT reduction and before ECCO2R initiation, peak hypercapnia and respiratory acidosis reached PaCO2 of 53.0 [50.0–55.0] mmHg and pH of 7.30 [7.24–7.36]. After 24 h of treatment, VT significantly decreased from 6.0 [6.0-6.1] to 4.0 [4.0-4.30] (p < 0.0001), driving pressure (∆P) from 12.0 [10.0–16.0] cmH2O to 10.0 [8.0–13.0] cmH2O (p < 0.0001), ventilatory ratio (VR) from 1.7 [1.5–2.1] to 1.3 [1.0-1.6] (p < 0.0001) and mechanical power from 18.8 [15.0–22.0] J/min to 11.8 [8.8–15.5] J/min (p < 0.0001). PaO2/FiO2 did not significantly change over time and respiratory acidosis resolved with treatment, as evidenced by normalization of pH and a reduction in PaCO2. Importantly, no major bleeding events, intracranial hemorrhages, or hemolysis were reported during the study. Conclusion: This study demonstrates that hypercapnic acidosis occurring during ultra-low VT ventilation (ULPV) can be safely mitigated with ECCO₂R in mechanically ventilated patients with mild to moderate ARDS. Moreover, under ULPV, ∆P, VR and mechanical power were improved without inducing hypoxemia. Trial registration: Clinicaltrials.gov: NCT04617093, Registration date: 30 October 2020.