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Intensive care medicine · Nov 2017
Randomized Controlled Trial Multicenter StudyImpact of tapered-cuff tracheal tube on microaspiration of gastric contents in intubated critically ill patients: a multicenter cluster-randomized cross-over controlled trial.
- 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, and BestCuff Study Group and the BoRéal Network.
- CHU Lille, Critical Care Center, rue E. Laine, 59037, Lille cedex, France.
- Intensive Care Med. 2017 Nov 1; 43 (11): 1562-1571.
PurposeStudies 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.MethodsAll 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.ResultsA 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.ConclusionsThis trial showed no significant impact of tapered-cuff tracheal tubes on abundant microaspiration of gastric contents.Trial RegistrationClinicalTrials.gov, number NCT01948635.
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