A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System:The MOBYBOX Trial

Prior treatment

• Patient has been treated with ECMO ≤ 48 hours.
• Patient is participating in an investigational drug or device study trial that has not reached the primary endpoint or that interferes with the current study endpoints.

Other illness

• Severe intracranial bleeding, which precludes the use of anticoagulation therapy or any other inability to be anticoagulated
• Any condition or organ dysfunction that would limit the likelihood of overall benefit from ECMO, such as severe, irreversible brain injury, hepatic and/or renal failure, or untreatable metastatic cancer;
• For veno-veno ECMO in the setting of respiratory failure the following exclusion criteria apply:
• Severe pulmonary hypertension (mPAP \> 50 mm Hg)
• Severe right or left sided heart failure (EF \< 25%)
• For veno-arterial ECMO in the setting of cardiac insufficiency:
• Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.

Lab values

• Immunosuppression with an absolute neutrophil count \< 400/mm3;

Other

• High pressure ventilation (FIO2 \> 0.9 and Pplateau \> 30 cm H2O) or high FIO2 requirements for more than 7 days;
• Excessive weight (\> 180 Kg)
• Severe irreversible brain injury (e.g., hypoxic brain injury)
• Inability to accept blood products;
• Severe aortic regurgitation
• Aortic dissection.
• The patient is moribund, or the patient has severe or deteriorating damage in critical body systems.

• Diagnosed with cardiac, respiratory or cardiorespiratory failure or imminent failure and 1 of the 5 following sets of findings:
  • A Murray score ≥ 3.0 and/or severe hypoxemia with A PaO2/FIO2 \> 100 mm on 0.9 FIO2;
  • Uncompensated hypercapnia with pH \<7.2 despite a Pplateau \> 30 cm H20;
  • Significant air leak/bronchopleural fistula;
  • Need for intubation in a patient on lung transplant list;
  • Immediate/risk of cardiac or respiratory collapse (pulmonary embolus, blocked airway, blocked blood flow, unresponsive to optimal care);
• Written consent of the patient or the legal guardian or external consulting physician as designated and approved by the Ethics Committee.