Efficiency of an electronic device in controlling tracheal cuff pressure in critically ill patients: a randomized controlled crossover study

BACKGROUND: Despite intermittent control of tracheal cuff pressure (P (cuff)) using a manual manometer, cuff underinflation (<20 cmH(2)O) and overinflation (>30 cmH(2)O) 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 P (cuff). 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 P (cuff) with 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, P (cuff) was continuously recorded, and pepsin and alpha amylase were quantitatively measured in tracheal aspirates. P (cuff) target was 25 cmH(2)O. 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 P (cuff), 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