Maguire Seamus, Haury Frances, Jew Korinne
Research and Development, Covidien Respiratory and Monitoring Solutions, Athlone, Ireland.
Medical Affairs, Covidien Respiratory and Monitoring Solutions, Boulder, CO, USA.
Med Devices (Auckl). 2015 Apr 21;8:185-92. doi: 10.2147/MDER.S76960. eCollection 2015.
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.
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.
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.
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.
带有TaperGuard™套囊的Shiley™成人柔性气管造口管通过其几何形状、材料、直径和壁厚进行设计，以尽量减少液体通过套囊的微误吸，并在气管中提供有效的气密封，同时将气管黏膜上过度接触压力的风险降至最低。该套囊还具有放气后的外形，这可能使其更容易通过造口部位插入。这种独特的设计被称为TaperGuard™套囊。本文报道的观察性体外研究的目的是比较TaperGuard™锥形套囊与传统的大容量低压圆柱形套囊（Shiley™一次性内套管气管造口管[DCT]）在施加的气管壁压力、空气和液体密封效果以及插入力方面的差异。
将两种套囊类型的三种尺寸的气管造口管放置在尺寸合适的气管模型中，并通过内表面的压力传感元件测量侧壁压力。通过在气管模型中给套囊充气（25 cmH2O）、在套囊上方注入水并测量液体通过套囊的泄漏来评估液体密封性能。为了测量空气泄漏，将管子连接到测试肺和呼吸机上，并通过从平均输送潮气量中减去平均呼出潮气量来计算泄漏量。使用拉伸试验机测量每种套囊放气的管子的插入力，以模拟通过造口部位的临床插入。
在所有测试条件下，锥形套囊施加在模型气管侧壁上的平均压力低于圆柱形套囊（P<0.05）。锥形套囊在模型气管侧壁上也表现出更均匀、更低的压力分布。与圆柱形套囊相比，每种测试管子尺寸的锥形套囊的平均空气和液体密封性能均有显著改善（P<0.05）。锥形套囊的插入力比圆柱形套囊小约40%。
在模型气管中，与带有圆柱形套囊的Shiley™一次性内套管气管造口管相比，带有TaperGuard™套囊的Shiley™成人柔性气管造口管施加的平均侧壁压力更低且压力分布更均匀。此外，它提供了更有效的液体和空气密封，并且插入所需的力更小。
