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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-30

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiac Failure Respiratory Failure Cardio-Respiratory Failure Imminent Cardiorespiratory or Respiratory Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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MOBYBOX System

extracorporeal cardiopulmonary support

Intervention Type DEVICE

Eligibility Criteria

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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.
* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No