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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство MOBYBOX System
  extracorporeal cardiopulmonary support

Первичные конечные точки

• Rates of device and procedure related serious adverse events [Срок оценки: 24 hours]

Вторичные конечные точки (3)

• Device performance success [Срок оценки: every 4 hours while the patient receives ECMO using the MOBYBOX device]
• Adverse Event rate [Срок оценки: 24 hours]
• Mortality rate [Срок оценки: 30 days]

Критерии участия

Критерии включения

• Diagnosed with cardiac, respiratory or cardiorespiratory failure or imminent 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/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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Германия · 4 центра

• Medizinische Hochschule Hannover — Hanover
• Universitätsklinikum Essen — Essen
• Universitätsklinikum Halle — Halle
• Helios Klinikum Erfurt — Erfurt

Идентификаторы

NCT: NCT04183660 · HVT-MB1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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