title: Efficiency of an electronic device in controlling tracheal cuff pressure in critically ill patients: a randomized controlled crossover study.
abstract: BACKGROUND
  Despite intermittent control of tracheal cuff pressure (Pcuff) using a manual manometer, cuff underinflation (<20 cmH2O) and overinflation (>30 cmH2O) frequently occur in intubated critically ill patients, resulting in increased risk of microaspiration and tracheal ischemic lesions. The primary objective of our study was to determine the efficiency of an electronic device in continuously controlling Pcuff. The secondary objective was to determine the impact of this device on the occurrence of microaspiration of gastric or oropharyngeal secretions.
  
  
  METHODS
  Eighteen patients requiring mechanical ventilation were included in this prospective randomized controlled crossover study. They randomly received either continuous control of Pcuffwith Mallinckrodt®device for 24 h, followed by discontinuous control with a manual manometer for 24 h, or the reverse sequence. During the 48 h after randomization, Pcuffwas continuously recorded, and pepsin and alpha amylase were quantitatively measured in tracheal aspirates. Pcufftarget was 25 cmH2O.
  
  
  RESULTS
  Clinical characteristics were similar during the two study periods, as well as mean airway pressure. Percentage of time spent with cuff overinflation or underinflation was significantly lower during continuous control compared with routine care period [median (IQR) 0.8 (0.1, 2) vs 20.9 (3.1, 40.1), p = 0.0009]. No significant difference was found in pepsin [median (IQR) 230 (151, 300) vs 259 (134, 368), p = 0.95] or in alpha amylase level [median (IQR) 1475 (528, 10,333) vs 2400 (1342, 15,391), p = 0.19] between continuous control and routine care periods, respectively.
  
  
  CONCLUSIONS
  The electronic device is efficient in controlling Pcuff, compared with routine care using a manometer. Further studies are needed to evaluate the impact of this device on intubation-related complications. Trial registration ClinicalTrials.gov Identifier: NCT01965821.
authors.affiliation: Centre de Réanimation, CHU Lille, 59000, Lille, France.
authors.forename: Anahita
authors.initials: A
authors.lastname: Rouzé
authors.affiliation: Centre d'Investigation Clinique, CHU Lille, 59000, Lille, France.
authors.forename: Julien
authors.initials: J
authors.lastname: De Jonckheere
authors.affiliation: Centre de Biologie et de Pathologie, CHU Lille, 59000, Lille, France.
authors.forename: Farid
authors.initials: F
authors.lastname: Zerimech
authors.affiliation: EA 2694 - Santé publique : épidémiologie et qualité des soins, CHU Lille, 59000, Lille, France.
authors.forename: Julien
authors.initials: J
authors.lastname: Labreuche
authors.affiliation: Centre de Réanimation, CHU Lille, 59000, Lille, France.
authors.forename: Erika
authors.initials: E
authors.lastname: Parmentier-Decrucq
authors.affiliation: Centre de Réanimation, CHU Lille, 59000, Lille, France.
authors.forename: Benoit
authors.initials: B
authors.lastname: Voisin
authors.affiliation: Centre de Réanimation, CHU Lille, 59000, Lille, France.
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Jaillette
authors.affiliation: Centre de Biologie et de Pathologie, CHU Lille, 59000, Lille, France.
authors.forename: Patrice
authors.initials: P
authors.lastname: Maboudou
authors.affiliation: Centre de Biologie et de Pathologie, CHU Lille, 59000, Lille, France.|Faculté de Pharmacie, Université Lille, 59000, Lille, France.
authors.forename: Malika
authors.initials: M
authors.lastname: Balduyck
authors.affiliation: Centre de Réanimation, CHU Lille, 59000, Lille, France. s-nseir@chru-lille.fr.|Faculté de Médecine, Université Lille, 59000, Lille, France. s-nseir@chru-lille.fr.
authors.forename: Saad
authors.initials: S
authors.lastname: Nseir
keywords: Complications; Intubation; Mechanical ventilation; Microaspiration; Tracheal cuff