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.
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;
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)
Consented patients with cardiorespiratory failure or ith severe respiratory failure who meet all of the inclusion and none of the exclusion criteria and in whom the investigator intends to treat the patient with cardiopulmonary support using the Hemovent MOBYBOX System.
Case-only
Prospective
MOBYBOX System
Deviceextracorporeal cardiopulmonary support
Rates of device and procedure related serious adverse events
Acute safety defined as rates of device and procedure related serious adverse events up to 24 hours post-intervention.
Device performance success
Device performance success (defined as the ability to establish either veno-arterial ECMO to support cardiorespiratory function and tissue oxygenation or veno-venous ECMO to support respiratory function and tissue oxygenation)
Adverse Event rate
Acute safety defined as rates adverse events up to 24 hours post-intervention.
Mortality rate
All-cause mortality up to 30 days post-intervention
Click on the lead sponsor to view all of their trials.
Hemovent GmbH
Lead sponsor
seleon GmbH
Collaborator
