title: Impact of tracheal cuff shape on microaspiration of gastric contents in intubated critically ill patients: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Ventilator-associated pneumonia (VAP) is the most common infection in intubated critically ill patients. Microaspiration of the contaminated gastric and oropharyngeal secretions is the main mechanism involved in the pathophysiology of VAP. Tracheal cuff plays an important role in stopping the progression of contaminated secretions into the lower respiratory tract. Previous in vitro studies suggested that conical cuff shape might be helpful in improving tracheal sealing. However, clinical studies found conflicting results. The aim of this study is to determine the impact of conical tracheal cuff shape on the microaspiration of gastric contents in critically ill patients.
  
  
  METHODS
  This prospective cluster randomized controlled crossover open-label trial is currently being conducted in ten French intensive care units (ICUs). Patients are allocated to intubation with a polyvinyl chloride (PVC) standard (barrel)-shaped or a PVC conical-shaped tracheal tube. The primary objective is to determine the impact of the conical shaped tracheal cuff on abundant microaspiration of gastric contents. Secondary outcomes include the incidence of microaspiration of oropharyngeal secretions, tracheobronchial colonization, VAP and ventilator-associated events. Abundant microaspiration is defined as the presence of pepsin at significant level (>200 ng/ml) in at least 30 % of the tracheal aspirates. Pepsin and amylase are quantitatively measured in all tracheal aspirates during the 48 h following inclusion. Quantitative tracheal aspirate culture is performed at inclusion and twice weekly. We plan to recruit 312 patients in the participating ICUs.
  
  
  CONCLUSIONS
  BEST Cuff is the first randomized controlled study evaluating the impact of PVC tracheal-cuff shape on gastric microaspirations in patients receiving invasive mechanical ventilation. Enrollment began in June 2014 and is expected to end in October 2015.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01948635 (registered 31 August 2013).
authors.affiliation: Critical Care Center, University Hospital of Lille, rue E. Laine, 59037, Lille Cedex, France. emmanuelle.jaillette@chru-lille.fr.
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Jaillette
authors.affiliation: Réanimation Polyvalente, CH Dr Duchenne, allée Jacques Monod, BP 609, 62321, Boulogne-Sur-Mer, France. g.brunin@ch-boulogne.fr.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Brunin
authors.affiliation: Réanimation Médicale, Hôpital C. Nicolle, 1 rue de Germont, 76031, Rouen Cedex, France. christophe.girault@chu-rouen.fr.
authors.forename: Christophe
authors.initials: C
authors.lastname: Girault
authors.affiliation: Laboratoire de Biochimie et Biologie Moléculaire, Université de Lille et Pôle de Biologie Pathologie Génétique du CHRU de Lille, 59000, Lille, France. farid.zerimech@chru-lille.fr.
authors.forename: Farid
authors.initials: F
authors.lastname: Zerimech
authors.affiliation: Réanimation Médicale et Infectieuse, CH de Tourcoing, 115 rue du Président Coty, 59208, Tourcoing Cedex, France. arnaudchiche@hotmail.com.
authors.forename: Arnaud
authors.initials: A
authors.lastname: Chiche
authors.affiliation: Réanimation Polyvalente, Hôpital Victor Provo, 17 bd Lacordaire, BP 359, 59056, Roubaix, France. celine.dedrie@ch-roubaix.fr.
authors.forename: Céline
authors.initials: C
authors.lastname: Broucqsault-Dedrie
authors.affiliation: Service de réanimation polyvalente, 130 Avenue Louis Herbeaux BP 6367, 59140, Dunkerque, France. Cyril.Fayolle@ch-dunkerque.fr.
authors.forename: Cyril
authors.initials: C
authors.lastname: Fayolle
authors.affiliation: Réanimation Polyvalente, CH Saint Philibert, 115 Rue du Grand But, BP 249, 59462, Lomme Cedex, France. franck.minacori@ghicl.net.
authors.forename: Franck
authors.initials: F
authors.lastname: Minacori
authors.affiliation: Réanimation Médicale, CH de Valenciennes, Avenue Desandrouin, BP479, 59322, Valenciennes Cedex, France. alves-i@ch-valenciennes.fr.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Alves
authors.affiliation: Réanimation Polyvalente, CH Dr Schaffner, 99 route de La Bassée, BP8, 62307, Lens Cedex, France. sbarrailler@ch-lens.fr.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Barrailler
authors.affiliation: Critical Care Center, University Hospital of Lille, rue E. Laine, 59037, Lille Cedex, France. laurent.robriquet@chru-lille.fr.
authors.forename: Laurent
authors.initials: L
authors.lastname: Robriquet
authors.affiliation: Réanimation Médicale, Hôpital C. Nicolle, 1 rue de Germont, 76031, Rouen Cedex, France. Fabienne.Tamion@chu-rouen.fr.
authors.forename: Fabienne
authors.initials: F
authors.lastname: Tamion
authors.affiliation: Réanimation Polyvalente, CH Dr Duchenne, allée Jacques Monod, BP 609, 62321, Boulogne-Sur-Mer, France. e.delaporte@ch-boulogne.fr.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Delaporte
authors.affiliation: Réanimation Médicale et Infectieuse, CH de Tourcoing, 115 rue du Président Coty, 59208, Tourcoing Cedex, France. dthellier@ch-tourcoing.fr.
authors.forename: Damien
authors.initials: D
authors.lastname: Thellier
authors.affiliation: Critical Care Center, University Hospital of Lille, rue E. Laine, 59037, Lille Cedex, France. claire.delcourte@chru-lille.fr.
authors.forename: Claire
authors.initials: C
authors.lastname: Delcourte
authors.affiliation: Clinique de Santé Publique, plateforme d'aide méthodologique, 59037, Lille Cedex, France. alain.duhamel@univ-lille2.fr.
authors.forename: Alain
authors.initials: A
authors.lastname: Duhamel
authors.affiliation: Critical Care Center, University Hospital of Lille, rue E. Laine, 59037, Lille Cedex, France. s-nseir@chru-lille.fr.|Medical School, Lille University, 1 place de Verdun, 59000, Lille, France. s-nseir@chru-lille.fr.
authors.forename: Saad
authors.initials: S
authors.lastname: Nseir
mesh_terms: D000681:Amylases / Q000378:metabolism; D001431:Bacteriological Techniques; D015415:Biomarkers / Q000378:metabolism; D015505:Chest Tubes / Q000009:adverse effects; D004796:Clinical Enzyme Tests; D002985:Clinical Protocols; D016638:Critical Illness; D018592:Cross-Over Studies; D004867:Equipment Design; D005602:France; D005766:Gastrointestinal Contents / Q000201:enzymology / Q000382:microbiology; D006801:Humans; D007362:Intensive Care Units; D007442:Intubation, Intratracheal / Q000009:adverse effects / Q000295:instrumentation*; D010434:Pepsin A / Q000378:metabolism; D053717:Pneumonia, Ventilator-Associated / Q000175:diagnosis / Q000209:etiology / Q000382:microbiology / Q000517:prevention & control*; D011143:Polyvinyl Chloride; D011446:Prospective Studies; D012107:Research Design; D012121:Respiration, Artificial / Q000009:adverse effects / Q000295:instrumentation*; D063466:Respiratory Aspiration of Gastric Contents / Q000175:diagnosis / Q000209:etiology / Q000382:microbiology / Q000517:prevention & control*; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D011143:Polyvinyl Chloride; D000681:Amylases; D010434:Pepsin A