Continuous Pneumatic Regulation of Tracheal Cuff Pressure to Decrease Ventilator-associated Pneumonia in Trauma Patients Who Were Mechanically Ventilated

Nicolas Marjanovic (1, 2, 3) , Matthieu Boisson (2, 1, 4) , Karim Asehnoune (5) , Arnaud Foucrier (6) , Sigismond Lasocki (7) , Carole Ichai (8) , Marc Leone (9, 10, 11) , Julien Pottecher (12, 13) , Jean-Yves Lefrant (14, 15) , Dominique Falcon (16) , Benoit Veber (17) , Russell Chabanne (18) , Claire-Marie Drevet (19) , Sébastien Pili-Floury (20) , Claire Dahyot-Fizelier (4, 2, 1) , Thomas Kerforne (4, 2, 1) , Sabrina Seguin (1) , Joe de Keizer (1) , Denis Frasca (2, 1, 21) , Jérémy Guenezan (1, 4) , Olivier Mimoz (1, 2, 4)

1 CHU de Poitiers [La Milétrie] - Centre hospitalier universitaire de Poitiers = Poitiers University Hospital
2 Université de Poitiers - Faculté de Médecine et de Pharmacie
3 CIC 1402 - CIC Poitiers – Centre d'investigation clinique de Poitiers
4 PHAR [Poitiers] - Pharmacologie des anti-infectieux
5 CHU Nantes - Centre Hospitalier Universitaire de Nantes
6 Département d'Anesthésie et Réanimation [Hôpital Beaujon]
7 Département d'Anesthésie-Réanimation [CHU Angers]
8 CHU Nice - Centre Hospitalier Universitaire de Nice
9 AMU - Aix Marseille Université
10 Service Anesthésie et Réanimation [Hôpital Nord - APHM]
11 MEPHI - Microbes évolution phylogénie et infections
12 Hôpital de Hautepierre [Strasbourg]
13 FMTS - Université de Strasbourg - Faculté de Médecine [Strabourg]
14 IMAGINE - Initial MAnagement and prevention of acute orGan failures IN critically ill patiEnts
15 CHU Nîmes - Centre Hospitalier Universitaire de Nîmes
16 CHUGA - Centre Hospitalier Universitaire [CHU Grenoble]
17 Service de Soins Intensifs [CHU Rouen]
18 CHU Clermont-Ferrand
19 Service d'anesthésie - réanimation chirurgicale [CHU de Dijon]
20 PCVP / CARDIO - Marqueurs pronostiques et facteurs de régulations des pathologies cardiaques et vasculaires - UFC ( UR 3920)
21 SPHERE - MethodS in Patients-centered outcomes and HEalth ResEarch

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.

Mots clés: infection; intensive care; pneumonia; tracheal cuff pressure; ventilator-associated.

Domaines: Sciences du Vivant [q-bio]; Sciences pharmaceutiques

Nicolas Marjanovic, Matthieu Boisson, Karim Asehnoune, Arnaud Foucrier, Sigismond Lasocki, et al.. Continuous Pneumatic Regulation of Tracheal Cuff Pressure to Decrease Ventilator-associated Pneumonia in Trauma Patients Who Were Mechanically Ventilated. Chest, 2021, 160 (2), pp.499-508. ⟨10.1016/j.chest.2021.03.007⟩. ⟨hal-03464545⟩