Automatic regulation of the endotracheal tube cuff pressure with a portable elastomeric device. A randomised controlled study

Abstract

BackgroundIntermittent manual correction of the endotracheal tube cuff pressure (Pcuff) may delay the detection of underinflation (source of contaminated oropharyngeal content microaspiration) or overinflation (exposing to airway damage). Devices for automated continuous correction of Pcuff are appealing but some are inconvenient, expensive or even harmful. This prospective randomised controlled study tested whether the tracoe Smart Cuff Manager™ reduced the rate of patients undergoing≥1 episode of underinflation (Pcuff<20 cmH2O), as compared with routine manual Pcuff correction. The rate of patients with≥1 overinflation episode (Pcuff>30 cmH2O) and the incidence of under/overinflation were also compared. MethodsPatients with acute brain injury and likely to receive invasive mechanical ventilation for>48h were randomly allocated to receive, during 48h, automated Pcuff correction (combined with manual correction) or manual correction alone. Pcuff was measured with a dedicated manual manometer, at least every 8h. ResultsSixty patients were included and randomised (32 patients with manual and 28 with automated Pcuff correction) for 506 measurements of Pcuff (269 and 237, respectively). Automated correction of Pcuff was associated with a lower rate of patients with≥1 episode of underinflation (63% and 18%, respectively, P<0.001), a lower incidence of underinflation episodes (15% vs. 2%; P<0.001), a lower rate of manual corrections (77% vs. 58%; P<0.001). For overinflation, there were no significant between-groups differences (2% vs. 2%). The incidence of early respiratory infections was similar in both groups (29% vs. 25%, P=0.78). ConclusionsThe adjunction of continuous Pcuff control with the Tracoe Smart Cuff Manager™ to routine manual intermittent correction reduced the incidence of Pcuff underinflation episodes without provoking overinflation. Trial RegistrationClinicalTrials NCT03330379. Registered 6 November 2017, https://clinicaltrials.gov/ct2/show/NCT03330379.