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Ultra-Protective Lung Ventilation With Extracorporeal CO2 Removal for Moderate ARDS

RecruitingNAAges 18 Years - 100 YearsAllUniversity of Bologna
NCT04903262 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Acute respiratory distress syndrome (ARDS) accounts for 10% of all ICU admissions and for 23% of patients requiring mechanical ventilation (MV). Its hospital mortality remains high, ranging from 34% in mild forms up to 46% in severe cases. Positive pressure MV remains the cornerstone of management, but at the same time it can contribute to worsening and maintenance of the lung injury when excessive stress and strain is applied to the lung parenchima (so-called ventilator-induced lung injury, VILI). VILI significantly contributes to the morbidity and mortality of ARDS patients, and it has been clearly demonstrated that protective (low-volume, low-pressure) MV settings are associated with a significant survival benefit. Unfortunately, in a certain proportion of ARDS cases, it is difficult to preserve acceptable gas exchange while maintaining protective ventilation settings, due to a high v

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years * On invasive mechanical ventilation for ≤ 96 hours * Presence of all of the following conditions for ≤ 24 hours: 100 \< PaO2/FiO2 ≤ 200 after 12 hours of "standardized ventilation" with PEEP ≥ 5; compliance of the respiratory system ≤ 0.5 ml/cmH2O per kg PBW; ventilatory ratio (VR) ≥ 1.5; bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules; respiratory failure not fully explained by cardiac failure or fluid overload Exclusion Criteria: * Pregnancy * ARDS with PaO2/FiO2\<100 or PaO2/FiO2\>200 under standardized ventilation with PEEP ≥ 5 cmH2O * Expected duration of mechanical ventilation \< 48 hours * Severe COPD * Chronic respiratory insufficiency with home ventilation or oxygen therapy * Currently receiving ECMO therapy * Acute brain injury * Severe liver insufficiency (Child-Pugh scores \>7) or fulminant hepatic failure * Heparin-induced thrombocytopenia * Contraindication for systemic anticoagulation * Platelet count \<50,000/mm3 * Prothrombin time-international normalized ratio (INR) \>1.5 * Patient moribund, decision to limit therapeutic interventions * End-stage disease * Unable to provide vascular access for ECCO2-R * Acute coronary syndrome * Actual body weight exceeding 1 kg per centimeter of height * Burns \> 40% total body surface * Bone marrow transplantation within the last 1 year
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What it tests

  • Ultraprotective ventilation with Extracorporeal CO2 removal
  • Conventional protective ventilation
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Where

1 site
IRCCS AOUBO Policlinico di Sant'Orsola
Bologna, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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