Background Endotracheal tube cuff underinflation contributes to microaspiration of contaminated oropharyngeal content, source of pneumonia. Overinflation exposes to airway damage. Intermittent manual adjustment of the cuff pressure (P cuff ) may delay the detection of under- or overinflation. Devices for automated continuous adjustment of P cuff are promising but some are inconvenient, expensive or even harmful. This prospective randomized controlled study tested whether the Tracoe Smart Cuff Manager TM reduced the rate of patients undergoing ≥1 episode of underinflation (P cuff <20 cmH 2 O), as compared with routine manual P cuff adjustment. Secondary endpoints included comparisons of the rate of patients with ≥1 overinflation episode (P cuff >30 cmH 2 O), of the incidence of under- and overinflation episodes and of their magnitude. Methods Patients likely to receive invasive mechanical ventilation for >48 hours because of acute brain injury were randomly allocated to receive, during 48 hours, automated P cuff adjustment (combined with manual adjustment) or manual adjustment alone. In each group, P cuff was measured with a dedicated manual manometer, at least every 8 hours. Results Sixty patients were analyzed (28 patients with automated and 32 with manual P cuff adjustment) for 506 measurements of P cuff (237 and 269, respectively). As compared with manual adjustment, automated adjustment of P cuff was associated with 1) a lower rate of patients with ≥1 episode of underinflation (63% and 18%, respectively, p<0.001), 2) a lower incidence of underinflation episodes (15% vs. 2%;p<0.001), 3) a lower rate of manual adjustments (77% vs. 56%;p<0.001) and 4) manual adjustments of lower magnitude (5.9±4.5 vs. 3.6±4.7 cmH 2 O;p<0.001). For overinflation, there was no significant between-groups differences (p>0.99). Conclusions The adjunction of a continuous P cuff control with the Tracoe Smart Cuff Manager TM to routine manual intermittent adjustment reduced both the incidence of P cuff underinflation episodes and their magnitude without provoking overinflation.