1. Continuous Pneumatic Regulation of Tracheal Cuff Pressure to Decrease Ventilator-associated Pneumonia in Trauma Patients Who Were Mechanically Ventilated
- Author
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Olivier Mimoz, Benoit Veber, Matthieu Boisson, Dominique Falcon, Carole Ichai, Claire-Marie Drevet, Lilit Kelesyan, Thiên-Nga Chamaraux-Tran, Laurent Muler, Julien Pottecher, Marc Leone, Abdelouaid Nadji, Hervé Quintard, Claire Dahyot-Fizelier, Belaid Bouhemad, Nicolas Marjanovic, Sigismond Lasocki, Claire Roger, Thomas Kerforne, Jean-Yves Lefrant, Catherine Paugam-Burtz, Marc Ginet, Antoine Roquilly, Elodie Caumon, Emmanuelle Hammad, Florian Grimaldi, Pierre-Olivier Ludes, Jérémy Guenezan, Arnaud Foucrier, Sébastien Leduc, Guillaume Besch, Sabrina Seguin, Russell Chabanne, Karim Asehnoune, Philippe Gouin, Pierre-Gildas Guitard, Denis Frasca, Maxime Léger, Sebastien Pili-Floury, Raphaël Cinotti, Marie-Héléne Po, Joe de Keizer, Soizic Gergaud, Thomas Gaillard, Centre hospitalier universitaire de Poitiers (CHU Poitiers), Université de Poitiers - Faculté de Médecine et de Pharmacie, Université de Poitiers, CIC - Poitiers, Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Pharmacologie des anti-infectieux (PHAR), Université de Poitiers-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], 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 [Grenoble] (CHU), 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 ( EA 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, Microbes évolution phylogénie et infections (MEPHI), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Marqueurs pronostiques et facteurs de régulations des pathologies cardiaques et vasculaires - UFC ( UR 3920) (PCVP / CARDIO), Chauzy, Alexia, Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), and Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques
- Subjects
Pulmonary and Respiratory Medicine ,medicine.medical_treatment ,[SDV]Life Sciences [q-bio] ,Population ,Critical Care and Intensive Care Medicine ,Tracheal tube ,03 medical and health sciences ,0302 clinical medicine ,Intensive care ,ventilator-associated ,medicine ,pneumonia ,030212 general & internal medicine ,education ,intensive care ,Mechanical ventilation ,education.field_of_study ,business.industry ,Tracheal intubation ,Ventilator-associated pneumonia ,[SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences ,medicine.disease ,infection ,3. Good health ,[SDV] Life Sciences [q-bio] ,[SDV.SP] Life Sciences [q-bio]/Pharmaceutical sciences ,030228 respiratory system ,Anesthesia ,Cuff ,tracheal cuff pressure ,Injury Severity Score ,Cardiology and Cardiovascular Medicine ,business - 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: www.clinicaltrials.gov.
- Published
- 2021