Contributors: Centre hospitalier universitaire de Poitiers = Poitiers University Hospital (CHU de Poitiers La Milétrie ); Université de Poitiers - Faculté de Médecine et de Pharmacie; Université de Poitiers = University of Poitiers (UP); CIC Poitiers – Centre d'investigation clinique de Poitiers (CIC 1402); Université de Poitiers = University of Poitiers (UP)-Centre hospitalier universitaire de Poitiers = Poitiers University Hospital (CHU de Poitiers La Milétrie )-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM); Pharmacologie des anti-infectieux (PHAR Poitiers ); Université de Poitiers = University of Poitiers (UP)-Institut National de la Santé et de la Recherche Médicale (INSERM); Centre Hospitalier Universitaire de Nantes (CHU Nantes); Département d'Anesthésie et Réanimation Hôpital Beaujon; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP); Département d'Anesthésie-Réanimation CHU Angers; Centre Hospitalier Universitaire d'Angers (CHU Angers); PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM); Centre Hospitalier Universitaire de Nice (CHU Nice); Aix Marseille Université (AMU); Service Anesthésie et Réanimation Hôpital Nord - APHM; Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital Nord CHU - APHM; Microbes évolution phylogénie et infections (MEPHI); Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS); Hôpital de Hautepierre Strasbourg; Université de Strasbourg - Faculté de Médecine Strabourg (FMTS); Initial MAnagement and prevention of acute orGan failures IN critically ill patiEnts (IMAGINE); Université de Montpellier (UM); Centre Hospitalier Universitaire de Nîmes (CHU Nîmes); Centre Hospitalier Universitaire CHU Grenoble (CHUGA); Service de Soins Intensifs CHU Rouen; CHU Rouen; Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN); Normandie Université (NU); CHU Clermont-Ferrand; Service d'anesthésie - réanimation chirurgicale CHU de Dijon; Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon); Marqueurs pronostiques et facteurs de régulations des pathologies cardiaques et vasculaires - UFC ( UR 3920) (PCVP / CARDIO); Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC); Université Bourgogne Franche-Comté COMUE (UBFC)-Université Bourgogne Franche-Comté COMUE (UBFC); MethodS in Patients-centered outcomes and HEalth ResEarch (SPHERE); Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques; Université de Nantes (UN)-Université de Nantes (UN); AGATE Study Group: Guillaume Besch, Bélaid Bouhemad, Elodie Caumon, Thien-Nga Chamaraux-Tran, Raphael Cinotti, Thomas Gaillard, Soizic Gergaud, Marc Ginet, Philippe Gouin, Florian Grimaldi, Pierre-Gildas Guitard, Emmanuelle Hammad, Lilit Kelesyan, Sébastien Leduc, Maxime Leger, Pierre-Olivier Ludes, Laurent Muler, Abdelouaid Nadji, Catherine Paugam-Burtz, Marie-Héléne Po, Hervé Quintard, Claire Roger, Antoine Roquilly
Abstract: International audience ; Background: Ventilator-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 question: Is 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 methods: In 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.Results: A 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.Interpretation: Continuous 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 registration: ClinicalTrials.gov; No.: NCT02534974; URL: ...
_0.png)
Processing Request
No Comments.