Cardiac Failure, Cardio-Respiratory Failure, Imminent Cardiorespiratory or Respiratory Failure, Respiratory Failure
Conditions
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.
Interventions
DEVICEMOBYBOX System
extracorporeal cardiopulmonary support
Sponsors
seleon GmbH
Hemovent GmbH
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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) * Severe irreversible brain injury (e.g., hypoxic brain injury) * Inability to accept blood products; * 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; * Immunosuppression with an absolute neutrophil count \< 400/mm3; * Patient has been treated with ECMO ≤ 48 hours. * For veno-veno ECMO in the setting of respiratory failure the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of device and procedure related serious adverse events | 24 hours | Acute safety defined as rates of device and procedure related serious adverse events up to 24 hours post-intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device performance success | every 4 hours while the patient receives ECMO using the MOBYBOX device | 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 | 24 hours | Acute safety defined as rates adverse events up to 24 hours post-intervention. |
| Mortality rate | 30 days | All-cause mortality up to 30 days post-intervention |
Countries
Germany
Contacts
Primary ContactYvonne Seibt
Outcome results
None listed