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Impact of tapered-cuff tracheal tube on microaspiration of gastric contents in intubated critically ill patients: a multicenter cluster-randomized cross-over controlled trial
Authors:Emmanuelle Jaillette  Christophe Girault  Guillaume Brunin  Farid Zerimech  Hélène Behal  Arnaud Chiche  Céline Broucqsault-Dedrie  Cyril Fayolle  Franck Minacori  Isabelle Alves  Stéphanie Barrailler  Julien Labreuche  Laurent Robriquet  Fabienne Tamion  Emmanuel Delaporte  Damien Thellier  Claire Delcourte  Alain Duhamel  Saad Nseir  BestCuff Study Group  the BoRéal Network
Affiliation:1.CHU Lille, Critical Care Center,Lille cedex,France;2.Department of Medical Intensive Care, Rouen University Hospital, and UPRES EA 3830-IRIB, Institute for Biomedical Research,Rouen University,Rouen,France;3.CH Dr Duchenne, Réanimation Polyvalente,Boulogne-Sur-Mer,France;4.CHU de Lille, P?le de Biologie Pathologie Génétique, Laboratoire de Biochimie et Biologie Moléculaire,Lille,France;5.CHU Lille, Clinique de Santé Publique, plateforme d’aide méthodologique,Lille Cedex,France;6.Réanimation Médicale et Infectieuse,Tourcoing Cedex,France;7.CH de Roubaix, Réanimation Polyvalente, H?pital Victor Provo,Roubaix,France;8.CH de Dunkerque, Service de réanimation polyvalente,Dunkerque,France;9.CH Saint Philibert, Réanimation Polyvalente,Lomme Cedex,France;10.Réanimation Médicale, CH de Valenciennes,Valenciennes Cedex,France;11.CH Dr Schaffner, Réanimation Polyvalente,Lens Cedex,France;12.Lille University, Medical School,Lille,France
Abstract:

Purpose

Studies on the impact of tapered-cuff tracheal tubes on rates of microaspiration and ventilator-associated pneumonia (VAP) in intubated patients have reported conflicting results. The aim of this study was to determine the influence of this shape of tracheal cuff on abundant microaspiration of gastric contents in critically ill patients.

Methods

All patients intubated in the intensive care unit (ICU) and requiring mechanical ventilation for at least 48 h were eligible for this multicenter cluster-randomized controlled cross-over open-label study. The primary outcome was abundant microaspiration of gastric contents, defined by the presence of pepsin at significant level in >30% of tracheal aspirates. Quantitative measurement of pepsin and salivary amylase was performed in all tracheal aspirates during the 48 h following enrollment.

Results

A total of 326 patients were enrolled in the ten participating ICUs (162 in the PVC tapered-cuff group and 164 in the standard-cuff group). Patient characteristics were similar in the two study groups. The proportion of patients with abundant microaspiration of gastric contents was 53.5% in the tapered-cuff and 51.0% in the standard-cuff group (odds ratio 1.14, 95% CI 0.72–1.82). While abundant microaspiration of oropharyngeal secretions was not significantly different (77.4 vs 68.6%, p = 0.095), the proportion of patients with tracheobronchial colonization was significantly lower (29.6 vs 43.3%, p = 0.01) in the tapered-cuff than in the standard-cuff group. No significant difference between the two groups was found for other secondary outcomes, including ventilator-associated events and VAP.

Conclusions

This trial showed no significant impact of tapered-cuff tracheal tubes on abundant microaspiration of gastric contents.

Trial registration

ClinicalTrials.gov, number NCT01948635.
Keywords:
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