Effect of a driving pressure-limiting strategy for patients with acute respiratory distress syndrome secondary to community-acquired pneumonia: the STAMINA randomised clinical trial

Abstract

Background: This study aimed to assess whether a driving pressure-limiting strategy based on positive end-expiratory pressure (PEEP) titration according to best respiratory system compliance and tidal volume adjustment increases the number of ventilator-free days within 28 days in patients with moderate to severe acute respiratory distress syndrome (ARDS).

Methods: This is a multi-centre, randomised trial, enrolling adults with moderate to severe ARDS secondary to community-acquired pneumonia. Patients were randomised to a driving pressure-limiting strategy or low PEEP strategy based on a PEEP:FiO₂ table. All patients received volume assist-control mode until day 3 or when considered ready for spontaneous modes of ventilation. The primary outcome was ventilator-free days within 28 days. Secondary outcomes were in-hospital and intensive care unit mortality at 90 days.

Results: The trial was stopped because of recruitment fatigue after 214 patients were randomised. In total, 198 patients (n=96 intervention group, n=102 control group) were available for analysis (median age 63 yr, [interquartile range 47-73 yr]; 36% were women). The mean difference in driving pressure up to day 3 between the intervention and control groups was -0.7 cm H₂O (95% confidence interval -1.4 to -0.1 cm H₂O). Mean ventilator-free days were 6 (sd 9) in the driving pressure-limiting strategy group and 7 (9) in the control group (proportional odds ratio 0.72, 95% confidence interval 0.39-1.32; P=0.28). There were no significant differences regarding secondary outcomes.

Conclusions: In patients with moderate to severe ARDS secondary to community-acquired pneumonia, a driving pressure-limiting strategy did not increase the number of ventilator-free days compared with a standard low PEEP strategy within 28 days.

Clinical trial registration: NCT04972318.

Keywords: acute respiratory distress syndrome; driving pressure; positive end-expiratory pressure; tidal volume; ventilator-induced lung injury.