ecco2R to facilitatE earLy libEration From mechanicAl Ventilation inpatientS With Copd Acute Exacerbation

Exclusion Criteria

• •Participation in other interventional studies
• •Patients already included in this study that need a new readmission because of a new aeCOPD episode
• •aeCOPD intubated \> 12 hours
• •Extubation within the previous 48 hours following intubation and invasive mechanical ventilation due to any cause
• •Anatomical abnormalities or vascular diseases preventing the correct insertion of the ECCO2R cannula
• •PaO2 to FiO2 ratio \< 150 on PEEP ≥ 5 cmH2O
• •Known or suspected pregnancy (women of childbearing potential require a pregnancy test)
• •Hemodynamic instability defined as
• •* MAP \< 60 mmHg despite the infusion of fluids or vasoactive drugs OR
• •* Failure to increase systolic blood pressure above 80-90 mmHg OR
• •* Need for inotropic drugs to maintain systolic blood pressure\> 85 mmHg OR
• •* ECG evidence of ischemia or significant uncontrolled ventricular arrhythmia
• •Acute multiple organ failure defined as more than two organ failures assessed by SOFA score. Organ dysfunction can be identified as an acute change in total SOFA score \> 2 points
• •Decompensated heart failure defined as an exacerbation of symptoms or signs after a period of relative stability such as dyspnea, fatigue or edema in the setting of previously established myocardial dysfunction (systolic or diastolic)32 and B-natriuretic peptide more than100 ng/L.
• •Tracheostomized patients
• •Untreated pulmonary embolism, pleural effusion, pneumothorax or bronchopleural fistula as the primary cause of acute respiratory failure
• •Hemoglobin \< 7 gr/dL that require daily transfusion to maintain hemoglobin above 7 gr/dL at the time of screening
• •Active major bleeding defined as35:
• •* Fatal bleeding
• •* Bleeding that is symptomatic and occurs in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, pericardial, in a non-operated joint, or intramuscular with compartment syndrome, assessed in consultation with the MD
• •* Extrasurgical site bleeding causing a fall in hemoglobin level of 2 gr/dL or more or leading to transfusion of two or more units of whole blood or red cells, with temporal association within 24-48 hours to the bleeding
• •Recent major surgery in the last 2 weeks
• •Platelet count \< 50 000/mm3
• •Prothrombin time-international normalized ratio (INR) \> 1.5 in the absence of anticoagulation therapy
• •Heparin-induced thrombocytopenia (HIT) or known paradoxical/allergic reactions to heparin
• •History within the previous 3 months of stroke or severe head trauma or intracranial arterio-venous malformation, or cerebral aneurysm, or central nervous mass lesion or intracranial bleeding
• •Epidural catheter in place or plan to insert an epidural catheter during the study
• •Gastrointestinal bleeding within the 6 weeks prior to study entry
• •Severe liver insufficiency (Child-Pugh scores \>7) or INR \> 1.6 suspected to be related to liver disease (liver associated coagulopathy)
• •Presence of severe (acute or chronic) renal failure defined as requiring any form of dialysis (including CRRT and CVVH) and/or having a serum creatinine \> 2.5 mg/dL and urine clearance \< 20 mL/hour
• •Inability to receive blood products
• •History of complications from extracorporeal support
• •Permanent home ventilation except for sleep-disordered breathing
• •Significant weakness or paralysis of respiratory muscles due to causes unrelated to aeCOPD
• •Recent (\< 7 days) prolonged (\> 24 hours) use of muscle paralyzing agents
• •Immunocompromised state defined as
• •* Received chemotherapy or radiation within the previous 45 days and still under treatment for the underlying cancer
• •* Received or currently receiving immunosuppressive therapy, excluding corticosteroids, within the last 3 months
• •* Known to have AIDS defined illness
• •Patients not expected to survive 6 months on the basis of premorbid health status
• •History of uncontrolled, major psychiatric disorder
• •Therapeutic restriction (DNR), moribund patient or not expected to survive current hospitalization
• •Consent declined