title: Efficiency of a mechanical device in controlling tracheal cuff pressure in intubated critically ill patients: a randomized controlled study.
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.
  
  
  BACKGROUND
  Clinicaltrial.gov: NCT02109003.
authors.affiliation: Critical Care Center, Hospital de Sabadell, Universidad Autonoma de Barcelona, CIBER enfermedades respiratorias, Corporació Sanitaria Parc Tauli, Parc Tauli 1, 08208, Sabadell, Spain, s-nseir@chru-lille.fr.
authors.forename: Saad
authors.initials: S
authors.lastname: Nseir
authors.forename: Andrey
authors.initials: A
authors.lastname: Rodriguez
authors.forename: Paula
authors.initials: P
authors.lastname: Saludes
authors.forename: Julien
authors.initials: J
authors.lastname: De Jonckheere
authors.forename: Jordi
authors.initials: J
authors.lastname: Valles
authors.forename: Antonio
authors.initials: A
authors.lastname: Artigas
authors.forename: Ignacio
authors.initials: I
authors.lastname: Martin-Loeches