• Nicolas Marjanovic, Matthieu Boisson, Karim Asehnoune, Arnaud Foucrier, Sigismond Lasocki, Carole Ichai, Marc Leone, Julien Pottecher, Jean-Yves Lefrant, Dominique Falcon, Benoit Veber, Russell Chabanne, Claire-Marie Drevet, Sébastien Pili-Floury, Claire Dahyot-Fizelier, Thomas Kerforne, Sabrina Seguin, Joe de Keizer, Denis Frasca, Jérémy Guenezan, Olivier Mimoz, and AGATE Study Group.
• Service des Urgences et SAMU 86 Centre 15, CHU de Poitiers, France; Université de Poitiers, Faculté de Médecine, Poitiers, France; INSERM CIC1402 Team 5 Acute Lung Injury and Ventilatory Support, Pharmacologie des Agents anti-infectieux, France.
• Chest. 2021 Aug 1; 160 (2): 499-508.

BackgroundVentilator-associated pneumonia (VAP) is the most frequent health care-associated infection in severely ill patients, and aspiration of contaminated oropharyngeal content around the cuff of the tracheal tube is the main route of contamination.Research QuestionIs continuous regulation of tracheal cuff pressure using a pneumatic device superior to manual assessment three times daily using a portable manometer (routine care) in preventing VAP in patients with severe trauma?Study Design And MethodsIn this open-label, randomized controlled superiority trial conducted in 13 French ICUs, adults (age ≥ 18 years) with severe trauma (Injury Severity Score > 15) and requiring invasive mechanical ventilation for ≥ 48 h were enrolled. Patients were randomly assigned (1:1) via a secure Web-based random number generator in permuted blocks of variable sizes to one of two groups according to the method of tracheal cuff pressure control. The primary outcome was the proportion of patients developing VAP within 28 days following the tracheal intubation, as determined by two assessors masked to group assignment, in the modified intention-to-treat population. This study is closed to new participants.ResultsA total of 434 patients were recruited between July 31, 2015, and February 15, 2018, of whom 216 were assigned to the intervention group and 218 to the control group. Seventy-three patients (33.8%) developed at least one episode of VAP within 28 days following the tracheal intubation in the intervention group compared with 64 patients (29.4%) in the control group (adjusted subdistribution hazard ratio, 0.96; 95% CI, 0.76-1.20; P = .71). No serious adverse events related to the use of the pneumatic device were noted.InterpretationContinuous regulation of cuff pressure of the tracheal tube using a pneumatic device was not superior to routine care in preventing VAP in patients with severe trauma.Clinical Trial RegistrationClinicalTrials.gov; No.: NCT02534974; URL: www.clinicaltrials.gov.Copyright © 2021 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

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