Extracorporeal Lung Assist to Avoid Intubation in Patients Failing NIV for Hypercapnic ARF (ECLAIR)

Extracorporeal Lung Assist to Avoid Intubation in Patients Failing Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure

The study´s intention is to evaluate the feasibility, safety and effectiveness of a pump driven extracorporeal device for removal of carbon dioxide from the blood in oder to avoid intubation and invasive mechanical ventilation in patients with acute respiratory failure retaining carbon dioxide due to the failure of their ventilatory muscle pump and not responding to prior non-invasive mask ventilation.

The study´s intention is to evaluate the feasibility, safety and effectiveness of a pump driven extracorporeal device for removal of carbon dioxide from the blood in oder to avoid intubation and invasive mechanical ventilation in patients with acute respiratory failure retaining carbon dioxide due to the failure of their ventilatory muscle pump and not responding to prior non-invasive mask ventilation. Since intubation with subsequent (prolonged) invasive mechanical ventilation is associated with considerable side effects this new strategy has the potential to improve overall clinical outcome in this selected patient group.

Hypercapnia, noninvasive ventilation, acute respiratory failure, endotracheal intubation, invasive mechanical ventilation

Treatment with the extracorporeal lung assist (ECLA) The ECLA is a pump driven (centrifugal pump) venovenous circuit, which removes carbon dioxide from the patients blood by means of a membrane through which the patients blood runs on the one side of the membrane and sweep gas on the other side removing the patient´s carbon dioxide. Blood flow range from 0.5 to 4.5 l/min and sweep gas flow between 1 and 10 l/min. At blood flows of 2 l/min and higher the device also oxygenates the patients blood. The diameter and length of cannulas and the sites of venous insertions are left to the decision of the treating physician. Cannulas are inserted in seldinger technique under sterile conditions. Function and patency of the extracorporeal circuit requires mild therapeutic anticoagulation.

Any complication associated with the pump driven extracorporeal lung assist device or with non-invasive or invasive mechanical ventilation or any associated treatments during the observational period

Changes in arterial blood gases before and after the initiation of the pump driven extracorporeal lung assist

Inclusion Criteria: acute or acute-on-chronic hypercapnic respiratory insufficiency (pH ≤ 7,35, PaCO2 > 45 mmHg) failure of noninvasive ventilation fulfilling criteria for endotracheal intubation Exclusion Criteria: under 18 years of age prior inclusion in other interventional study pregnancy heparin allergy or heparin-induced thrombocytopenia type 2 on home non-invasive ventilator "Do not resuscitate" order or moribund condition life expectancy less than 6 months no informed consent available

Department of Intensive Care Medicine, University Medical-Center Hamburg-Eppendorf (plus 10 further centres in Germany, Austria and the Netherlands)

Kluge S, Braune SA, Engel M, Nierhaus A, Frings D, Ebelt H, Uhrig A, Metschke M, Wegscheider K, Suttorp N, Rousseau S. Avoiding invasive mechanical ventilation by extracorporeal carbon dioxide removal in patients failing noninvasive ventilation. Intensive Care Med. 2012 Oct;38(10):1632-9. doi: 10.1007/s00134-012-2649-2. Epub 2012 Jul 27.

Braune S, Sieweke A, Brettner F, Staudinger T, Joannidis M, Verbrugge S, Frings D, Nierhaus A, Wegscheider K, Kluge S. 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. Intensive Care Med. 2016 Sep;42(9):1437-44. doi: 10.1007/s00134-016-4452-y. Epub 2016 Jul 25.