title: Randomized Pilot Trial of Two Modified Endotracheal Tubes To Prevent Ventilator-associated Pneumonia.
abstract: BACKGROUND
  Ventilator-associated pneumonia (VAP) is a prevalent and costly nosocomial infection related to instrumentation of the airway with an endotracheal tube (ETT), enabling microaspiration of contaminated secretions. Modification of the ETT design to reduce microaspiration and/or biofilm formation may play an important role in VAP prevention. However, there is insufficient evidence to provide strong recommendations regarding the use of modified ETT and unaddressed safety concerns.
  
  
  OBJECTIVE
  We performed a pilot randomized controlled trial comparing two modified ETTs designed specifically to prevent VAP, with the standard ETT, to test the feasibility of and inform planning for a large, pivotal, randomized trial.
  
  
  METHODS
  This study was conducted with institutional review board approval under exception from informed consent. We randomized in a blinded fashion patients undergoing emergency endotracheal intubation both out of and in hospital to receive one of three different ETT types: (1) a polyurethane-cuffed tube (PUC-ETT), (2) a polyurethane-cuffed tube equipped with a port for continuous aspiration of subglottic secretions (PUC-CASS-ETT), or a (3) standard polyvinylchloride-cuffed tube (PVC-ETT). In addition to investigating feasibility and safety, the study coprimary end points were tracheal bacterial colonization reaching a cfu count >10(6) cfu per milliliter and the incidence of invasively diagnosed VAP.
  
  
  RESULTS
  A total of 102 subjects were randomized and met the eligibility criteria. Randomization procedures performed well and integrity of blinding at randomization was maintained. The majority of intubations occurred in the hospital setting (n = 77), and the remainder occurred out of hospital (n = 25). Compared with the PVC-ETT, there were no significant differences in tracheal colonization for PUC-ETT (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.31-3.09) or for PUC-CASS-ETT (OR, 1.26; 95% CI, 0.42-3.76). There were no differences in the risk of invasively diagnosed VAP (OR, 1.14; 95% CI, 0.21-6.08 for PUC-ETT; OR, 1.47; 95% CI, 0.30-7.10 for PUC-CASS-ETT), or of clinically diagnosed VAP by either clinical signs or chest radiograph criteria. We did not observe unexpected or serious adverse events related to the devices.
  
  
  CONCLUSIONS
  A randomized trial of ETTs inserted during emergency intubation for the prevention of VAP is feasible and did not appear to carry heightened safety concerns. These preliminary data did not suggest different patterns of tracheal colonization or occurrence of VAP among the study groups. Clinical trial registered with www.clinicaltrials.gov (NCT01744483).
authors.affiliation: 1 Department of Anesthesiology and Pain Medicine, and.|2 Physicians Anesthesia Service and Swedish Medical Group, Swedish Medical Center, Seattle, Washington.
authors.forename: Steven
authors.initials: S
authors.lastname: Deem
authors.affiliation: 3 Department of Biostatistics, University of Washington, Seattle, Washington.|4 Department of Public Health and Preventive Medicine, and.
authors.forename: David
authors.initials: D
authors.lastname: Yanez
authors.affiliation: 1 Department of Anesthesiology and Pain Medicine, and.
authors.forename: Laura
authors.initials: L
authors.lastname: Sissons-Ross
authors.affiliation: 1 Department of Anesthesiology and Pain Medicine, and.
authors.forename: Jo Ann Elrod
authors.initials: JA
authors.lastname: Broeckel
authors.affiliation: 3 Department of Biostatistics, University of Washington, Seattle, Washington.
authors.forename: Stephen
authors.initials: S
authors.lastname: Daniel
authors.affiliation: 1 Department of Anesthesiology and Pain Medicine, and.|4 Department of Public Health and Preventive Medicine, and.|5 Department of Anesthesiology and Perioperative Medicine, Oregon Health and Sciences University, Portland, Oregon.
authors.forename: Miriam
authors.initials: M
authors.lastname: Treggiari
mesh_terms: D000328:Adult; D000368:Aged; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D006801:Humans; D007442:Intubation, Intratracheal / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D053717:Pneumonia, Ventilator-Associated / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control; D016896:Treatment Outcome
keywords: clinical trial; microaspiration; nosocomial pneumonia; subglottic suction