Ultra-protective lung ventilation with extracorporeal CO2 removal for ARDS
Official title: Strategy of Ultra-Protective Lung Ventilation With Extracorporeal CO2 Removal for New-Onset Moderate ARDS: A Prospective Multicenter Randomized Clinical Trial
Run by University of Bologna · NCT04903262 · Data updated 2026-11-12
This study is testing a new way of helping people with moderate Acute Respiratory Distress Syndrome (ARDS) breathe better while protecting their lungs from damage caused by ventilators.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 230 (estimated) |
| Sponsor | University of Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Status | Recruiting |
| Started | December 1, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | March 31, 2027 |
| Registry record updated | April 2, 2025 |
| Trial ID | NCT04903262 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who are on invasive mechanical ventilation for no more than 96 hours and meet specific clinical criteria for moderate ARDS.
✕Probably not a fit
Patients with severe COPD, chronic respiratory insufficiency requiring home ventilation, or those expected to need mechanical ventilation for less than 48 hours may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of ultra-protective lung ventilation combined with extracorporeal CO2 removal in patients suffering from moderate Acute Respiratory Distress Syndrome (ARDS). The approach aims to minimize ventilator-induced lung injury (VILI) while ensuring adequate gas exchange in patients who are on invasive mechanical ventilation. By applying this innovative ventilation strategy, the study seeks to improve patient outcomes and reduce mortality associated with ARDS. The trial will include patients who meet specific criteria related to their respiratory condition and mechanical ventilation status.
Why it matters
Potential benefit: If successful, this approach could significantly reduce mortality rates and improve recovery outcomes for patients with moderate ARDS.
How similar studies have gone: While the use of protective ventilation strategies has been established, the combination with extracorporeal CO2 removal is a novel approach that has not been extensively tested in this specific context.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
IRCCS AOUBO Policlinico di Sant'Orsola
Bologna, Italy Recruiting
Study contacts
- Study coordinator: Tommaso Tonetti, M.D.
- Email: tommaso.tonetti@unibo.it
- Phone: +39-0512143268
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.