The feasibility and safety of extracorporeal carbon dioxide removal to avoid intubation in patients with COPD unresponsive to noninvasive ventilation for acute hypercapnic respiratory failure (ECLAIR study): multicentre case–control study
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The aim of the study was to evaluate the feasibility and safety of avoiding invasive mechanical ventilation (IMV) by using extracorporeal CO2 removal (ECCO2R) in patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) and acute hypercapnic respiratory failure refractory to noninvasive ventilation (NIV).
Case–control study. Patients with acute hypercapnic respiratory failure refractory to NIV being treated with a pump-driven veno-venous ECCO2R system (iLA-Activve®; Novalung, Heilbronn, Germany) were prospectively observed in five European intensive care units (ICU). Inclusion criteria were respiratory acidosis (pH ≤ 7.35, PaCO2 > 45 mmHg) with predefined criteria for endotracheal intubation (ClinicalTrials.gov NCT01784367). The historical controls were patients with acute hypercapnic respiratory failure refractory to NIV who were treated with IMV. The matching criteria were main diagnosis, age, SAPS-II score and pH.
Twenty-five cases (48.0 % male, mean age 67.3 years) were matched with 25 controls. Intubation was avoided in 14 patients (56.0 %) in the ECCO2R group with a mean extracorporeal blood flow of 1.3 L/min. Seven patients were intubated because of progressive hypoxaemia and four owing to ventilatory failure despite ECCO2R and NIV. Relevant ECCO2R-associated adverse events were observed in 11 patients (44.0 %), of whom 9 (36.0 %) suffered major bleeding complications. The mean time on IMV, ICU stay and hospital stay in the case and control groups were 8.3 vs. 13.7, 28.9 vs. 24.0 and 36.9 vs. 37.0 days, respectively, and the 90-day mortality rates were 28.0 vs. 28.0 %.
The use of veno-venous ECCO2R to avoid invasive mechanical ventilation was successful in just over half of the cases. However, relevant ECCO2R-associated complications occurred in over one-third of cases. Despite the shorter period of IMV in the ECCO2R group there were no significant differences in length of stay or in 28- and 90-day mortality rates between the two groups. Larger, randomised studies are warranted for further assessment of the effectiveness of ECCO2R.
KeywordsEndotracheal intubation Mechanical ventilation Extracorporeal carbon dioxide removal COPD Hypercapnia Acute respiratory failure
We thank all involved ICU staff of the participating centres for their commitment and effort, without whom the ECLAIR study could not have been successfully completed. Our special thanks go to Birgit Füllekrug and Brigitte Singer, the ECLAIR study nurses in the Department of Intensive Care Medicine in the Medical Center Hamburg-Eppendorf.
Compliance with ethical standards
Conflicts of interest
SB, FB, TS, DF, and AN have received lecture honoraria from Novalung GmbH, Heilbronn, Germany. SK is a member of the advisory board of Novalung GmbH and therefore has received advisor honoraria. All other authors declare that they have no conflicts of interest.
NOVALUNG GmbH (Heilbronn, Germany) provided all components of the extracorporeal circuit (iLA-Activve®) including cannulas. The company did not have any role in study design, data collection, data analysis, data interpretation, preparing the report and any decision about its publication.
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