Continuous Pneumatic Regulation of Tracheal Cuff Pressure to Decrease Ventilator-associated Pneumonia in Trauma Patients Who Were Mechanically Ventilated: The AGATE Multicenter Randomized Controlled Study.
infection
intensive care
pneumonia
tracheal cuff pressure
ventilator-associated
Journal
Chest
ISSN: 1931-3543
Titre abrégé: Chest
Pays: United States
ID NLM: 0231335
Informations de publication
Date de publication:
08 2021
08 2021
Historique:
received:
22
09
2020
revised:
17
02
2021
accepted:
01
03
2021
pubmed:
18
3
2021
medline:
4
1
2022
entrez:
17
3
2021
Statut:
ppublish
Résumé
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. 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? 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. 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. 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. ClinicalTrials.gov; No.: NCT02534974; URL: www.clinicaltrials.gov.
Sections du résumé
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.
Identifiants
pubmed: 33727034
pii: S0012-3692(21)00481-5
doi: 10.1016/j.chest.2021.03.007
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT02534974']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
499-508Investigateurs
Guillaume Besch
(G)
Bélaid Bouhemad
(B)
Elodie Caumon
(E)
Thien-Nga Chamaraux-Tran
(TN)
Raphael Cinotti
(R)
Thomas Gaillard
(T)
Soizic Gergaud
(S)
Marc Ginet
(M)
Philippe Gouin
(P)
Florian Grimaldi
(F)
Pierre-Gildas Guitard
(PG)
Emmanuelle Hammad
(E)
Lilit Kelesyan
(L)
Sébastien Leduc
(S)
Maxime Leger
(M)
Pierre-Olivier Ludes
(PO)
Laurent Muler
(L)
Abdelouaid Nadji
(A)
Catherine Paugam-Burtz
(C)
Marie-Héléne Po
(MH)
Hervé Quintard
(H)
Claire Roger
(C)
Antoine Roquilly
(A)
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2021 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.