A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System:The MOBYBOX Trial
- Conditions
- Cardio-Respiratory FailureCardiac FailureRespiratory Failure
- Registration Number
- NCT04183660
- Lead Sponsor
- Hemovent GmbH
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
-
Diagnosed with cardiac, respiratory or cardiorespiratory 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 cardiac or respiratory collapse (pulmonary embolus, blocked airway, 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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)
Trial Locations
- Locations (2)
Medizinische Hochschule Hannover
🇩🇪Hannover, Niedersachsen, Germany
Universitätsklinikum Essen
🇩🇪Essen, NRW, Germany