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_2O during the two periods

Results

The percentage of time spent with P _cuff 20–30 cmH_2O (median (IQR) 34 % (17–57) versus 50 % (35–64), p  = 0.184) and the percentage of time spent with P _cuff <20 cmH_2O (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_2O 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_2O, 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