BackgroundCuff pressure (Pcuff) control is mandatory to avoid leakage of oral secretions passing the tracheal tube and tracheal ischemia. The aim of the present trial was to determine the efficacy of a mechanical device (PressureEasy®) in the continuous control of Pcuff in patients intubated with polyvinyl chloride (PVC)-cuffed tracheal tubes, compared with routine care using a manometer.MethodsThis is a prospective, randomized, controlled, cross-over study. All patients requiring intubation with a predicted duration of mechanical ventilation ≥48 h were eligible. Eighteen patients randomly received continuous control of Pcuff with PressureEasy® device for 24 h, followed by discontinuous control (every 4 h) with a manual manometer for 24 h, or vice versa. Pcuff and airway pressure were continuously recorded. Pcuff target was 25 cmH2O during the two periods.ResultsThe percentage of time spent with Pcuff 20–30 cmH2O (median (IQR) 34 % (17–57) versus 50 % (35–64), p = 0.184) and the percentage of time spent with Pcuff <20 cmH2O (23 % (5–63) versus 43 % (16–60), p = 0.5) were similar during continuous control of Pcuff and routine care, respectively. However, the percentage of time spent with Pcuff >30 cmH2O was significantly higher during continuous control compared with routine care of tracheal cuff (26 % (14–39) versus 7 % (1–18), p = 0.002). No significant difference was found in Pcuff (25 (18–28) versus 21 (18–26), p = 0.17), mean airway pressure (14 (10–17) versus 14 (11–16), p = 0.679), or coefficient of variation of Pcuff (19 % (11–26) versus 20 % (11–25), p = 0.679) during continuous control compared with routine care of tracheal cuff, respectively.ConclusionsPressureEasy® did not demonstrate a better control of Pcuff between 20 and 30 cmH2O, compared with routine care using a manometer. Moreover, the device use resulted in significantly higher time spent with overinflation of tracheal cuff, which might increase the risk for tracheal ischemic lesions.Trial registrationClinicaltrial.gov: NCT02109003