About this 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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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)
Severe irreversible brain injury (e.g., hypoxic brain injury)
Trial design
Treatments tested in this trial
- MOBYBOX System
Treatment groups
Sponsors and collaborators
Hemovent GmbH
Lead sponsor
seleon GmbH
Collaborator