A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System for Cardiac and Respiratory Support: The MOBYBOX Trial
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.
• 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.