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

Saad Nseir, Andrey Rodriguez, Paula Saludes, Julien De Jonckheere, Jordi Valles, Antonio Artigas, Ignacio Martin-Loeches, Saad Nseir, Andrey Rodriguez, Paula Saludes, Julien De Jonckheere, Jordi Valles, Antonio Artigas, Ignacio Martin-Loeches

Abstract

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 cmH2O during the two periods.

Results: The percentage of time spent with P cuff 20-30 cmH2O (median (IQR) 34 % (17-57) versus 50 % (35-64), p = 0.184) and the percentage of time spent with P cuff <20 cmH2O (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 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 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 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 registration: Clinicaltrial.gov: NCT02109003.

Figures

Fig. 1
Fig. 1
The PressureEasy® device. a Tracheal tube, (b) ventilator circuit, (c) PressureEasy®, and (d) external tracheal cuff
Fig. 2
Fig. 2
Description of connections between pressure transducers, ventilator, and tracheal tube. a Tracheal tube, (b) connection between external cuff and the three-way stopcock, (c) ventilator, (d) three-way stopcock, (e) PressureEasy® device or manometer, (f) pressure transducers connected to the ventilator and to tracheal cuff, and (g) laptop

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