ARDS is a major health issue internationally. Ventilator settings poorly adapted to physiology could contribute to the high mortality seen in these patients. Individualization of mechanical ventilation is therefore expected to decrease mortality and to result in a faster ventilator liberation. The study is designed to test the benefits of a physiology-based approach to mechanical ventilation in patients with ARDS; it is particularly well suited for patients with COVID-19 induced ARDS and there will a be a stratification based on the suspicion of COVID-19. It is hypothesized that individualization of mechanical ventilation should improve the management of patients with suspected COVID-19 induced ARDS and patients with non-COVID-19 induced ARDS, reduce the duration of mechanical ventilation, and improve patient outcomes.
- Our design is a phase III multicentre international RCT for patients with suspected COVID-19 induced ARDS and patients with non-COVID-19 induced ARDS, with an adaptive design.
- Eligibility criteria: We only enroll patients who are 18 years or older with moderate or severe ARDS within 48 h of meeting Berlin ARDS criteria
- The study D60 mortality as primary endpoint.
- Study procedures are as follows: The experimental arm use the recruitment to inflation ratio to detect if the patient is recruitable as well as the detection of airway closure (and the measurement of the airway opening pressure) and maintain the level of effort during pressure support ventilation by targeting the occlusion pressure (P0.1) between 1.0 and 3.9 cm H2O, a measurement available on all recent ventilators. The control group allows the use of either the high or the low PEEP-FiO2 table derived from ARDSNet protocols. Each centre will decide which approach they choose in their own centre or will decide on a patient per patient basis. The ventilator strategy applied in this trial can be performed on any mechanical ventilator, without additional equipment.
- The number of participants is 370 in each group (COVID-19 patients and non-COVID-19 patients) order to power the study on mortality as primary endpoint.