Continuous pneumatic regulation of tracheal cuff pressure to decrease ventilator-associated pneumonia in mechanically ventilated trauma patients: the AGATE multicenter randomized controlled study

ABSTRACT Background Ventilator-associated pneumonia (VAP) is the most frequent healthcare-associated infection in severely ill patients and aspiration of contaminated oropharyngeal content around the cuff of the tracheal tube is the main route of contamination. Research question Is continuous regulation of tracheal cuff pressure using a pneumatic device superior to manual assessment three times daily using a portable manometer (routine care) in preventing VAP in severe trauma patients? Study design and methods In this open-label, randomised-controlled superiority trial conducted in 13 French intensive care units, we enrolled adults (age ≥18 years) suffering from severe trauma (Injury severity score >15) and requiring invasive mechanical ventilation for 48 hours or longer. Patients were randomly assigned (1:1) via a secure web-based random number generator in permuted blocks of variable sizes to one of two groups according to the method of tracheal cuff pressure control. The primary outcome was the proportion of patients developing VAP within 28 days following the tracheal intubation, as determined by two assessors masked to group assignment, in the modified intention-to-treat population. This study is closed to new participants. Results 434 patients were recruited between 31/07/2015 and 15/02/2018, of which 216 were assigned to the intervention group and 218 to the control group. 73 patients (33·8%) developed at least one episode of VAP within 28 days following the tracheal intubation in the intervention group compared with 64 patients (29·4%) in the control group (adjusted sub-distribution HR 0·96 [95% CI 0·76-1·20]; p=0·71). No serious adverse events related to the use of the pneumatic device were noted. Interpretation Continuous regulation of cuff pressure of the tracheal tube using a pneumatic device was not superior to routine care in preventing VAP in severe trauma patients.