A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System:The MOBYBOX Trial
Trial Parameters
Brief Summary
The purpose of this study is to evaluate prospectively the safety and performance of the MOBYBOX System in the veno-arterial configuration in patients with cardiorespiratory failure or in the veno-venous configuration in patients with severe respiratory failure.
Eligibility Criteria
Inclusion Criteria: * Diagnosed with cardiac, respiratory or cardiorespiratory failure or imminent failure and 1 of the 5 following sets of findings: 1. A Murray score ≥ 3.0 and/or severe hypoxemia with A PaO2/FIO2 \> 100 mm on 0.9 FIO2; 2. Uncompensated hypercapnia with pH \<7.2 despite a Pplateau \> 30 cm H20; 3. Significant air leak/bronchopleural fistula; 4. Need for intubation in a patient on lung transplant list; 5. 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. Exclusion Criteria: * High pressure ventilation (FIO2 \> 0.9 and Pplateau \> 30 cm H2O) or high FIO2 requirements for more than 7 days; * Severe intracranial bleeding, which precludes the use of anticoagulation therapy or any other inability to be anticoagulated * Excessive weight (\> 180 Kg) * S