NCT04903262 Ultra-Protective Lung Ventilation With Extracorporeal CO2 Removal for Moderate ARDS
| NCT ID | NCT04903262 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Bologna |
| Condition | Acute Respiratory Distress Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 230 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 230 participants in total. It began in 2024-12-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 ventilatory load. In these cases, extracorporeal CO2 removal (ECCO2R) can be applied to grant the application of protective or even ultra-protective mechanical ventilation settings. The main outcome of this multicenter, prospective, randomized, comparative open trial is to determine whether early ECCO2R allowing ultraprotective mechanical ventilation improves the outcomes of patients with moderate ARDS.
Eligibility 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
Contact & Investigator
Marco Ranieri, M.D.
STUDY CHAIR
University of Bari
Frequently Asked Questions
Who can join the NCT04903262 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Acute Respiratory Distress Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04903262 currently recruiting?
Yes, NCT04903262 is actively recruiting participants. Contact the research team at tommaso.tonetti@unibo.it for enrollment information.
Where is the NCT04903262 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT04903262 clinical trial?
NCT04903262 is sponsored by University of Bologna. The principal investigator is Marco Ranieri, M.D. at University of Bari. The trial plans to enroll 230 participants.