title: An in vitro comparison of tracheostomy tube cuffs.
abstract: BACKGROUND
  The Shiley™ Flexible adult tracheostomy tube with TaperGuard™ cuff has been designed through its geometry, materials, diameter, and wall thickness to minimize micro-aspiration of fluids past the cuff and to provide an effective air seal in the trachea while also minimizing the risk of excessive contact pressure on the tracheal mucosa. The cuff also has a deflated profile that may allow for easier insertion through the stoma site. This unique design is known as the TaperGuard™ cuff. The purpose of the observational, in vitro study reported here was to compare the TaperGuard™ taper-shaped cuff to a conventional high-volume low-pressure cylindrical-shaped cuff (Shiley™ Disposable Inner Cannula Tracheostomy Tube [DCT]) with respect to applied tracheal wall pressure, air and fluid sealing efficacy, and insertion force.
  
  
  METHODS
  Three sizes of tracheostomy tubes with the two cuff types were placed in appropriately sized tracheal models and lateral wall pressure was measured via pressure-sensing elements on the inner surface. Fluid sealing performance was assessed by inflating the cuffs within the tracheal models (25 cmH2O), instilling water above the cuff, and measuring fluid leakage past the cuff. To measure air leak, tubes were attached to a test lung and ventilator, and leak was calculated by subtracting the average exhaled tidal volume from the average delivered tidal volume. A tensile test machine was used to measure insertion force for each tube with the cuff deflated to simulate clinical insertion through a stoma site.
  
  
  RESULTS
  The average pressure exerted on the lateral wall of the model trachea was lower for the taper-shaped cuff than for the cylindrical cuff under all test conditions (P<0.05). The taper-shaped cuff also demonstrated a more even, lower pressure distribution along the lateral wall of the model trachea. The average air and fluid seal performance with the taper-shaped cuff was significantly improved, when compared to the cylindrical-shaped cuff, for each tube size tested (P<0.05). The insertion force for the taper-shaped cuff was ~40% less than that for the cylindrical-shaped cuff.
  
  
  CONCLUSIONS
  In a model trachea, the Shiley™ Flexible Adult tracheostomy tube with TaperGuard™ cuff, when compared to the Shiley™ Disposable Inner Cannula Tracheostomy tube with cylindrical cuff, exerted a lower average lateral wall pressure and a more evenly distributed pressure. In addition, it provided more effective fluid and air seals and required less force to insert.
authors.affiliation: Research and Development, Covidien Respiratory and Monitoring Solutions, Athlone, Ireland.
authors.forename: Seamus
authors.initials: S
authors.lastname: Maguire
authors.affiliation: Medical Affairs, Covidien Respiratory and Monitoring Solutions, Boulder, CO, USA.
authors.forename: Frances
authors.initials: F
authors.lastname: Haury
authors.affiliation: Medical Affairs, Covidien Respiratory and Monitoring Solutions, Boulder, CO, USA.
authors.forename: Korinne
authors.initials: K
authors.lastname: Jew
keywords: air seal; airway device; cuff pressure; fluid seal; intra-cuff pressure; taper-shaped cuff