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Background <p>Extracorporeal carbon dioxide removal (ECCO<sub>2</sub>R), 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 ECCO<sub>2</sub>R, 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.</p> Methods <p>Between April 2021 and December 2023, 58 patients were treated with ECCO<sub>2</sub>R (16 in combination with CRRT). Tidal volume (V<sub>T</sub>) was reduced stepwise from 6 mL/kg to 4 mL/kg. Once the partial pressure of carbon dioxide (PaCO<sub>2</sub>) exceeded 50 mmHg, sweep gas (100% oxygen at 10&#xa0;L/min) was initiated to provide ECCO<sub>2</sub>R. Outcomes were measured at 8 and 24&#xa0;h, while safety was monitored until discharge or day 28.</p> Results <p>During V<sub>T</sub> reduction and before ECCO<sub>2</sub>R initiation, peak hypercapnia and respiratory acidosis reached PaCO<sub>2</sub> of 53.0 [50.0–55.0] mmHg and pH of 7.30 [7.24–7.36]. After 24&#xa0;h of treatment, V<sub>T</sub> significantly decreased from 6.0 [6.0-6.1] to 4.0 [4.0-4.30] (<i>p</i> &lt; 0.0001), driving pressure (∆P) from 12.0 [10.0–16.0] cmH<sub>2</sub>O to 10.0 [8.0–13.0] cmH<sub>2</sub>O (<i>p</i> &lt; 0.0001), ventilatory ratio (VR) from 1.7 [1.5–2.1] to 1.3 [1.0-1.6] (<i>p</i> &lt; 0.0001) and mechanical power from 18.8 [15.0–22.0] J/min to 11.8 [8.8–15.5] J/min (<i>p</i> &lt; 0.0001). PaO<sub>2</sub>/FiO<sub>2</sub> did not significantly change over time and respiratory acidosis resolved with treatment, as evidenced by normalization of pH and a reduction in PaCO<sub>2</sub>. Importantly, no major bleeding events, intracranial hemorrhages, or hemolysis were reported during the study.</p> Conclusion <p>This study demonstrates that hypercapnic acidosis occurring during ultra-low V<sub>T</sub> 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.</p> Trial registration <p>Clinicaltrials.gov: NCT04617093, Registration date: 30 October 2020.</p>

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

  • 期刊论文

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  • 发表日期：

    2026年1月6日

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  • Alain Combes,
  • Bruno Levy,
  • Romain Tapponnier,
  • Gilles Capellier,
  • Armand Mekontso Dessap,
  • Thibault Duburcq,
  • Vincent Castelain,
  • Jean-Marie Forel,
  • Fabrice Uhel,
  • Julien Mayaux,
  • Jacques Goldstein,
  • Jörg Kurz,
  • Kai Harenski,
  • William Montgomery,
  • Rhea Parreno,
  • Samir Jaber

摘要

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.