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

NCT04903262 NA RECRUITING

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.

Details

Lead sponsor	University of Bologna
Phase	NA
Status	RECRUITING
Enrolment	230
Start date	Sun Dec 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Mar 31 2027 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Acute Respiratory Distress Syndrome

Interventions

• Ultraprotective ventilation with Extracorporeal CO2 removal
• Conventional protective ventilation

Countries

Italy