Emmanuelle Jaillette1, Christophe Girault2, Guillaume Brunin3, Farid Zerimech4, Hélène Behal5, Arnaud Chiche6, Céline Broucqsault-Dedrie7, Cyril Fayolle8, Franck Minacori9, Isabelle Alves10, Stéphanie Barrailler11, Julien Labreuche5, Laurent Robriquet1, Fabienne Tamion2, Emmanuel Delaporte3, Damien Thellier6, Claire Delcourte1, Alain Duhamel5, Saad Nseir12,13. 1. CHU Lille, Critical Care Center, rue E. Laine, 59037, 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, Allée Jacques Monod, BP 609, 62321, Boulogne-Sur-Mer, France. 4. CHU de Lille, Pôle de Biologie Pathologie Génétique, Laboratoire de Biochimie et Biologie Moléculaire, 59000, Lille, France. 5. CHU Lille, Clinique de Santé Publique, plateforme d'aide méthodologique, 59037, Lille Cedex, France. 6. Réanimation Médicale et Infectieuse, 115 rue du Président Coty, 59208, Tourcoing Cedex, France. 7. CH de Roubaix, Réanimation Polyvalente, Hôpital Victor Provo, 17 bd Lacordaire, BP 359, 59056, Roubaix, France. 8. CH de Dunkerque, Service de réanimation polyvalente, 130 Avenue Louis Herbeaux BP 6367, 59140, Dunkerque, France. 9. CH Saint Philibert, Réanimation Polyvalente, 115 Rue du Grand But, BP 249, 59462, Lomme Cedex, France. 10. Réanimation Médicale, CH de Valenciennes, Avenue Desandrouin, BP479, 59322, Valenciennes Cedex, France. 11. CH Dr Schaffner, Réanimation Polyvalente, 99 route de La Bassée, BP8, 62307, Lens Cedex, France. 12. CHU Lille, Critical Care Center, rue E. Laine, 59037, Lille cedex, France. s-nseir@chru-lille.fr. 13. Lille University, Medical School, 59000, Lille, France. s-nseir@chru-lille.fr.
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.
RCT Entities:
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 illpatients. 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.
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