title: Impact of tapered-cuff tracheal tube on microaspiration of gastric contents in intubated critically ill patients: a multicenter cluster-randomized cross-over controlled trial.
abstract: OBJECTIVE
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov, number NCT01948635.
authors.affiliation: CHU Lille, Critical Care Center, rue E. Laine, 59037, Lille cedex, France.
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Jaillette
authors.affiliation: Department of Medical Intensive Care, Rouen University Hospital, and UPRES EA 3830-IRIB, Institute for Biomedical Research, Rouen University, Rouen, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Girault
authors.affiliation: CH Dr Duchenne, Réanimation Polyvalente, Allée Jacques Monod, BP 609, 62321, Boulogne-Sur-Mer, France.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Brunin
authors.affiliation: CHU de Lille, Pôle de Biologie Pathologie Génétique, Laboratoire de Biochimie et Biologie Moléculaire, 59000, Lille, France.
authors.forename: Farid
authors.initials: F
authors.lastname: Zerimech
authors.affiliation: CHU Lille, Clinique de Santé Publique, plateforme d'aide méthodologique, 59037, Lille Cedex, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: Behal
authors.affiliation: Réanimation Médicale et Infectieuse, 115 rue du Président Coty, 59208, Tourcoing Cedex, France.
authors.forename: Arnaud
authors.initials: A
authors.lastname: Chiche
authors.affiliation: CH de Roubaix, Réanimation Polyvalente, Hôpital Victor Provo, 17 bd Lacordaire, BP 359, 59056, Roubaix, France.
authors.forename: Céline
authors.initials: C
authors.lastname: Broucqsault-Dedrie
authors.affiliation: CH de Dunkerque, Service de réanimation polyvalente, 130 Avenue Louis Herbeaux BP 6367, 59140, Dunkerque, France.
authors.forename: Cyril
authors.initials: C
authors.lastname: Fayolle
authors.affiliation: CH Saint Philibert, Réanimation Polyvalente, 115 Rue du Grand But, BP 249, 59462, Lomme Cedex, France.
authors.forename: Franck
authors.initials: F
authors.lastname: Minacori
authors.affiliation: Réanimation Médicale, CH de Valenciennes, Avenue Desandrouin, BP479, 59322, Valenciennes Cedex, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Alves
authors.affiliation: CH Dr Schaffner, Réanimation Polyvalente, 99 route de La Bassée, BP8, 62307, Lens Cedex, France.
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Barrailler
authors.affiliation: CHU Lille, Clinique de Santé Publique, plateforme d'aide méthodologique, 59037, Lille Cedex, France.
authors.forename: Julien
authors.initials: J
authors.lastname: Labreuche
authors.affiliation: CHU Lille, Critical Care Center, rue E. Laine, 59037, Lille cedex, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Robriquet
authors.affiliation: Department of Medical Intensive Care, Rouen University Hospital, and UPRES EA 3830-IRIB, Institute for Biomedical Research, Rouen University, Rouen, France.
authors.forename: Fabienne
authors.initials: F
authors.lastname: Tamion
authors.affiliation: CH Dr Duchenne, Réanimation Polyvalente, Allée Jacques Monod, BP 609, 62321, Boulogne-Sur-Mer, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Delaporte
authors.affiliation: Réanimation Médicale et Infectieuse, 115 rue du Président Coty, 59208, Tourcoing Cedex, France.
authors.forename: Damien
authors.initials: D
authors.lastname: Thellier
authors.affiliation: CHU Lille, Critical Care Center, rue E. Laine, 59037, Lille cedex, France.
authors.forename: Claire
authors.initials: C
authors.lastname: Delcourte
authors.affiliation: CHU Lille, Clinique de Santé Publique, plateforme d'aide méthodologique, 59037, Lille Cedex, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Duhamel
authors.affiliation: CHU Lille, Critical Care Center, rue E. Laine, 59037, Lille cedex, France. s-nseir@chru-lille.fr.|Lille University, Medical School, 59000, Lille, France. s-nseir@chru-lille.fr.
authors.forename: Saad
authors.identifier: http://orcid.org/0000-0002-7618-0357
authors.initials: S
authors.lastname: Nseir
mesh_terms: D000368:Aged; D000681:Amylases / Q000032:analysis; D015415:Biomarkers / Q000032:analysis; D018592:Cross-Over Studies; D004797:Enzyme-Linked Immunosorbent Assay; D004867:Equipment Design; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D007442:Intubation, Intratracheal / Q000009:adverse effects / Q000295:instrumentation*; D008297:Male; D008875:Middle Aged; D010434:Pepsin A / Q000032:analysis; D053717:Pneumonia, Ventilator-Associated / Q000175:diagnosis / Q000209:etiology / Q000382:microbiology / Q000517:prevention & control*; D011446:Prospective Studies; D012121:Respiration, Artificial / Q000009:adverse effects*; D063466:Respiratory Aspiration of Gastric Contents / Q000201:enzymology / Q000209:etiology / Q000382:microbiology / Q000517:prevention & control*
chemical_list: D015415:Biomarkers; D000681:Amylases; D010434:Pepsin A
keywords: Intubation; Microaspiration; Tracheal cuff; Ventilator-associated events; Ventilator-associated pneumonia