PurposeWe assessed feasibility and safety of extracorporeal carbon dioxide removal (ECCO2R) to facilitate ultra-protective ventilation (V-T 4mL/kg and P(PLAT)25cmH(2)O) in patients with moderate acute respiratory distress syndrome (ARDS).MethodsProspective multicenter international phase 2 study. Primary endpoint was the proportion of patients achieving ultra-protective ventilation with PaCO2 not increasing more than 20% from baseline, and arterial pH>7.30. Severe adverse events (SAE) and ECCO2R-related adverse events (ECCO2R-AE) were reported to an independent data and safety monitoring board. We used lower CO2 extraction and higher CO2 extraction devices (membrane lung cross-sectional area 0.59 vs. 1.30m(2); flow 300-500mL/min vs. 800-1000mL/min, respectively).ResultsNinety-five patients were enrolled. The proportion of patients who achieved ultra-protective settings by 8h and 24h was 78% (74 out of 95 patients; 95% confidence interval 68-89%) and 82% (78 out of 95 patients; 95% confidence interval 76-88%), respectively. ECCO2R was maintained for 5 [3-8]days. Six SAEs were reported; two of them were attributed to ECCO2R (brain hemorrhage and pneumothorax). ECCO2R-AEs were reported in 39% of the patients. A total of 69 patients (73%) were alive at day 28. Fifty-nine patients (62%) were alive at hospital discharge.ConclusionsUse of ECCO2R to facilitate ultra-protective ventilation was feasible. A randomized clinical trial is required to assess the overall benefits and harms.Clinicaltrials.govNCT02282657
Combes, A., Fanelli, V., Pham, T., Ranieri, V., Goligher, E., Brodie, D., Pesenti, A., Beale, R., Brochard, L., Chiche, J., Fan, E., De Backer, D., Francois, G., Ferguson, N., Laffey, J., Mercat, A., Mcauley, D., Muller, T., Quintel, M., Vincent, J., Taccone, F., Peperstraete, H., Morimont, P., Schmidt, M., Levy, B., Diehl, J., Guervilly, C., Capelier, G., Vieillard-Baron, A., Messika, J., Karagiannidis, C., Moerer, O., Urbino, R., Antonelli, M., Mojoli, F., Alessandri, F., Grasselli, G., Donker, D., Ferrer, R., Mancebo, J., Slutsky, A., Feasibility and safety of extracorporeal CO2 removal to enhance protective ventilation in acute respiratory distress syndrome: the SUPERNOVA study, <<INTENSIVE CARE MEDICINE>>, 2019; 45 (5): 592-600. [doi:10.1007/s00134-019-05567-4] [http://hdl.handle.net/10807/171374]
Feasibility and safety of extracorporeal CO2 removal to enhance protective ventilation in acute respiratory distress syndrome: the SUPERNOVA study
Antonelli, M;
2019
Abstract
PurposeWe assessed feasibility and safety of extracorporeal carbon dioxide removal (ECCO2R) to facilitate ultra-protective ventilation (V-T 4mL/kg and P(PLAT)25cmH(2)O) in patients with moderate acute respiratory distress syndrome (ARDS).MethodsProspective multicenter international phase 2 study. Primary endpoint was the proportion of patients achieving ultra-protective ventilation with PaCO2 not increasing more than 20% from baseline, and arterial pH>7.30. Severe adverse events (SAE) and ECCO2R-related adverse events (ECCO2R-AE) were reported to an independent data and safety monitoring board. We used lower CO2 extraction and higher CO2 extraction devices (membrane lung cross-sectional area 0.59 vs. 1.30m(2); flow 300-500mL/min vs. 800-1000mL/min, respectively).ResultsNinety-five patients were enrolled. The proportion of patients who achieved ultra-protective settings by 8h and 24h was 78% (74 out of 95 patients; 95% confidence interval 68-89%) and 82% (78 out of 95 patients; 95% confidence interval 76-88%), respectively. ECCO2R was maintained for 5 [3-8]days. Six SAEs were reported; two of them were attributed to ECCO2R (brain hemorrhage and pneumothorax). ECCO2R-AEs were reported in 39% of the patients. A total of 69 patients (73%) were alive at day 28. Fifty-nine patients (62%) were alive at hospital discharge.ConclusionsUse of ECCO2R to facilitate ultra-protective ventilation was feasible. A randomized clinical trial is required to assess the overall benefits and harms.Clinicaltrials.govNCT02282657
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