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.
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
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
Parallel
Ultraprotective ventilation with Extracorporeal CO2 removal
Procedure/SurgeryHLS5.0 Cardiohelp® (Getinge Cardiopulmonary Care, Rastatt, Germany): 1.3 m² polymethylpentene hollow fiber membrane oxygenator. The extracorporeal blood flow is in the range of 1000 to 1500 mL/min. Sweep gas (air or oxygen) is drawn through the hollow fibers by a vacuum pump, creating a diffusion gradient for gas exchange across the membrane.
Conventional protective ventilation
Procedure/SurgeryConventional lung protective mechanical ventilation, as described in the arm description ("standardized ventilation")
Number of ventilator-free days (VFDs) at 28 days after randomization.
VFD to-day 28 is defined as the number of days of unassisted breathing to day 28 after randomization, assuming a patient survives for at least two consecutive calendar days after initiating unassisted breathing and remains free of assisted breathing.
28-day all-cause mortality
All patients will be classified as either "alive at Study Day 28" or, if dead, "dead at Study Day 28."
90-day all-cause mortality
All patients will be classified as either "alive at Study Day 90" or, if dead, "dead at Study Day 90".
Cumulative incidence of severe adverse events during 28 days after randomization
Device-related and/or patient-related severe adverse events
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University of Bologna
Lead sponsor
University of Bari Aldo Moro
Sponsor institution
Getinge Group
Collaborator
