Efficiency of a mechanical device in controlling tracheal cuff pressure in intubated critically ill patients: a randomized controlled study

BACKGROUND: Cuff pressure (P(cuff)) 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 P(cuff) in patients intubated with polyvinyl chloride (PVC)-cuffed tracheal tubes, compared with routine care using a manometer. METHODS: This 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 P(cuff) with PressureEasy® device for 24 h, followed by discontinuous control (every 4 h) with a manual manometer for 24 h, or vice versa. P(cuff) and airway pressure were continuously recorded. P(cuff) target was 25 cmH(2)O during the two periods. RESULTS: The percentage of time spent with P(cuff) 20–30 cmH(2)O (median (IQR) 34 % (17–57) versus 50 % (35–64), p = 0.184) and the percentage of time spent with P(cuff) <20 cmH(2)O (23 % (5–63) versus 43 % (16–60), p = 0.5) were similar during continuous control of P(cuff) and routine care, respectively. However, the percentage of time spent with P(cuff) >30 cmH(2)O 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 P(cuff) (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 P(cuff) (19 % (11–26) versus 20 % (11–25), p = 0.679) during continuous control compared with routine care of tracheal cuff, respectively. CONCLUSIONS: PressureEasy® did not demonstrate a better control of P(cuff) between 20 and 30 cmH(2)O, 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 REGISTRATION: Clinicaltrial.gov: NCT02109003