A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System:The MOBYBOX Trial

Launched by HEMOVENT GMBH · Nov 28, 2019

Keywords

ClinConnect Summary

The MOBYBOX Trial is a study designed to evaluate the safety and effectiveness of a new medical device called the Hemovent Extracorporeal Cardiopulmonary Support System. This device helps support patients who are experiencing severe heart and lung problems, known as cardiorespiratory failure. The study is currently looking for participants who are diagnosed with these conditions and meet certain criteria, such as having low oxygen levels or needing help with breathing or heart function.

To be eligible, participants need to be between the ages of 18 and 80 and must have specific medical needs related to their heart or lungs. They should also be able to provide consent for participation. Throughout the trial, participants will receive careful monitoring and support while using the device to see how well it works in real-life situations. It's important to note that there are certain health conditions that may prevent someone from joining the study, such as major brain injuries or severe heart issues. Overall, this trial aims to gather more information to potentially improve treatment options for patients with serious heart and lung problems.

Gender

ALL

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)
• • 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 exclusion criteria apply:
• • Severe pulmonary hypertension (mPAP \> 50 mm Hg)
• • Severe right or left sided heart failure (EF \< 25%)
• * For veno-arterial ECMO in the setting of cardiac insufficiency:
• • Severe aortic regurgitation
• • Aortic dissection.
• • The patient is moribund, or the patient has severe or deteriorating damage in critical body systems.
• • Patient is participating in an investigational drug or device study trial that has not reached the primary endpoint or that interferes with the current study endpoints.
• • Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.