Abstract：
BACKGROUND: The i-gel® Plus is a modified version of the i-gel® supraglottic airway device. It contains a wider drainage port; a longer tip; ramps inside the breathing channel; and an additional port for oxygen delivery. There has been no prospective evaluation of this device in clinical practice.
METHODS: This international, multicentre, prospective cohort study aimed to evaluate the performance of the i-gel Plus in adult patients undergoing elective procedures under general anaesthesia. The primary outcome was overall insertion success rate, defined as the ability to provide effective airway management through the device from insertion until the end of the surgical procedure. Secondary outcomes included device performance and incidence of postoperative adverse events. Data from the first 1000 patients are reported.
RESULTS: In total, 1012 patients were enrolled; 12 forms were excluded from the final analysis due to incomplete data leaving 1000 included patients (545 female). Overall insertion success rate was 98.6%, with a first-attempt success rate of insertion of 88.2%. A significant difference between females and males was seen for the overall success rate (97.4% vs. 99.6% respectively) but not for first-attempt successful insertion. Mean (SD) oropharyngeal seal pressure was 32 (7) cmH2O. The only independent factor that increased the risk of first-attempt failure was low operator experience. Complications included desaturation < 85% in 0.6%; traces of blood on the device in 7.4%; laryngospasm in 0.5%; and gastric contents inside the bowl in 0.2% of patients.
CONCLUSIONS: The i-gel Plus appears to be an effective supraglottic airway device that is associated with a high insertion success rate and a reasonably low incidence of complications.
METHODS: This international, multicentre, prospective cohort study aimed to evaluate the performance of the i-gel Plus in adult patients undergoing elective procedures under general anaesthesia. The primary outcome was overall insertion success rate, defined as the ability to provide effective airway management through the device from insertion until the end of the surgical procedure. Secondary outcomes included device performance and incidence of postoperative adverse events. Data from the first 1000 patients are reported.
RESULTS: In total, 1012 patients were enrolled; 12 forms were excluded from the final analysis due to incomplete data leaving 1000 included patients (545 female). Overall insertion success rate was 98.6%, with a first-attempt success rate of insertion of 88.2%. A significant difference between females and males was seen for the overall success rate (97.4% vs. 99.6% respectively) but not for first-attempt successful insertion. Mean (SD) oropharyngeal seal pressure was 32 (7) cmH2O. The only independent factor that increased the risk of first-attempt failure was low operator experience. Complications included desaturation < 85% in 0.6%; traces of blood on the device in 7.4%; laryngospasm in 0.5%; and gastric contents inside the bowl in 0.2% of patients.
CONCLUSIONS: The i-gel Plus appears to be an effective supraglottic airway device that is associated with a high insertion success rate and a reasonably low incidence of complications.
摘要：
背景：i-gel®Plus是i-gel®声门上气道装置的改进型。它包含更宽的排水口；更长的尖端；呼吸通道内的坡道；以及用于输送氧气的附加端口。在临床实践中尚未对该装置进行前瞻性评估。
方法：这个国际，多中心,前瞻性队列研究旨在评估i-gelPlus在全身麻醉下接受择期手术的成年患者中的表现。主要结果是总体插入成功率，定义为从插入装置到外科手术结束通过装置提供有效气道管理的能力。次要结果包括器械性能和术后不良事件的发生率。报告了来自前1000名患者的数据。
结果：总计，1012名患者入选；由于数据不完整，最终分析中排除了12种形式，留下了1000名患者（545名女性）。总体插入成功率为98.6%,首次尝试插入成功率为88.2%。总体成功率在女性和男性之间存在显着差异（97.4％vs.分别为99.6％），但不是第一次尝试成功插入。平均（SD）口咽密封压为32（7）cmH2O。增加首次尝试失败风险的唯一独立因素是低操作经验。并发症包括:在0.6%的患者中,去饱和<85%;在装置上的血液痕迹为7.4%;在0.5%的患者中,喉痉挛;在0.2%的患者中,碗内的胃内容物。
结论：i-gelPlus似乎是一种有效的声门上气道装置，具有较高的插入成功率和较低的并发症发生率。
方法：这个国际，多中心,前瞻性队列研究旨在评估i-gelPlus在全身麻醉下接受择期手术的成年患者中的表现。主要结果是总体插入成功率，定义为从插入装置到外科手术结束通过装置提供有效气道管理的能力。次要结果包括器械性能和术后不良事件的发生率。报告了来自前1000名患者的数据。
结果：总计，1012名患者入选；由于数据不完整，最终分析中排除了12种形式，留下了1000名患者（545名女性）。总体插入成功率为98.6%,首次尝试插入成功率为88.2%。总体成功率在女性和男性之间存在显着差异（97.4％vs.分别为99.6％），但不是第一次尝试成功插入。平均（SD）口咽密封压为32（7）cmH2O。增加首次尝试失败风险的唯一独立因素是低操作经验。并发症包括:在0.6%的患者中,去饱和<85%;在装置上的血液痕迹为7.4%;在0.5%的患者中,喉痉挛;在0.2%的患者中,碗内的胃内容物。
结论：i-gelPlus似乎是一种有效的声门上气道装置，具有较高的插入成功率和较低的并发症发生率。
