Actively Recruiting
Ultra-Protective Lung Ventilation With Extracorporeal CO2 Removal for Moderate ARDS
Led by University of Bologna · Updated on 2025-04-02
230
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
Sponsors
U
University of Bologna
Lead Sponsor
G
Getinge Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ultra-Protective Lung Ventilation With Extracorporeal CO2 Removal for Moderate ARDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- On invasive mechanical ventilation for 96 hours or less
- Moderate ARDS with PaO2/FiO2 between 100 and 200 after 12 hours of standardized ventilation with PEEP 5 or higher
- Respiratory system compliance of 0.5 ml/cmH2O per kg predicted body weight or less
- Ventilatory ratio of 1.5 or higher
- Bilateral lung opacities not caused by effusions, collapse, or nodules
- Respiratory failure not fully explained by heart failure or fluid overload
You will not qualify if you...
- Pregnancy
- ARDS with PaO2/FiO2 less than 100 or greater than 200 under standardized ventilation with PEEP 5 or higher
- Expected mechanical ventilation duration less than 48 hours
- Severe chronic obstructive pulmonary disease (COPD)
- Chronic respiratory failure requiring home ventilation or oxygen therapy
- Currently receiving extracorporeal membrane oxygenation (ECMO) therapy
- Acute brain injury
- Severe liver failure (Child-Pugh score above 7) or fulminant hepatic failure
- Heparin-induced thrombocytopenia
- Contraindications to systemic anticoagulation
- Platelet count below 50,000/mm3
- Prothrombin time-INR above 1.5
- Patient moribund or with a decision to limit therapeutic interventions
- End-stage disease
- Unable to provide vascular access for ECCO2R
- Acute coronary syndrome
- Body weight exceeding 1 kg per centimeter of height
- Burns covering more than 40% of total body surface
- Bone marrow transplantation within the last year
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
IRCCS AOUBO Policlinico di Sant'Orsola
Bologna, Italy
Actively Recruiting
Research Team
T
Tommaso Tonetti, M.D.
CONTACT
M
Marco Ranieri, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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