Department of Anesthesiology, Perioperative Medicine and Pain Management, University of Miami Miller School of Medicine, Gautier Bldg, Room 415, 1011 N.W. 15th Street, Miami, FL 33136, USA.
Br J Anaesth. 2012 Dec;109(6):990-5. doi: 10.1093/bja/aes309. Epub 2012 Sep 6.
The i-gel™ supraglottic airway device has been studied in randomized controlled studies, but it has not been evaluated in a large prospective patient cohort. Therefore, we performed this prospective multicentre observational study to evaluate success rates, airway leak pressure, risk factors for i-gel failure, and adverse events.
With Ethics Committee approval and waiver of patients' consent, data about anaesthesia providers, patient characteristics, and the performance of the i-gel were recorded in five independent hospitals in Switzerland over a period of 24 months. We analysed success rates, leak pressures, adverse events, and risk factors for failure.
Data from 2049 i-gel uses were analysed. Patients' mean age was 47 (range 6-91) yr. The primary i-gel success rate without changing size was 93%; the overall success rate was 96%. Insertion was deemed very easy or easy in 92%. The mean airway leak pressure was 26 (8) cm H(2)O. The mean anaesthesia time was 67 (42) min. Risk factors associated with i-gel failure were males (P<0.001), impaired mandibular subluxation (P=0.01), poor dentition (P=0.02), and older age (P<0.01). Adverse events recorded were laryngeal spasms (n=25, 1.2%), blood stained airway devices (n=79, 3.9%), transient nerve damage (n=2, 0.1%), one case of transient vasovagal asystole, and one glottic haematoma.
The i-gel is a reliable supraglottic airway device failing in <5% and providing high airway leak pressures. Males, impaired mandibular subluxation, poor dentition, and older age are risk factors associated with primary device failure. Serious adverse events are rare.
i-gel™ 声门上气道装置已在随机对照研究中进行了研究，但尚未在大型前瞻性患者队列中进行评估。因此，我们进行了这项前瞻性多中心观察性研究，以评估成功率、气道泄漏压力、i-gel 失败的危险因素和不良事件。
在获得伦理委员会批准和豁免患者同意的情况下，在瑞士的五家独立医院进行了为期 24 个月的麻醉提供者、患者特征和 i-gel 性能的数据记录。我们分析了成功率、泄漏压力、不良事件和失败的危险因素。
分析了 2049 例 i-gel 使用的数据。患者的平均年龄为 47（6-91）岁。不改变尺寸的主要 i-gel 成功率为 93%；总体成功率为 96%。92%的插入被认为非常容易或容易。平均气道泄漏压力为 26（8）cmH2O。平均麻醉时间为 67（42）分钟。与 i-gel 失败相关的危险因素是男性（P<0.001）、下颌骨脱位不良（P=0.01）、牙齿状况不佳（P=0.02）和年龄较大（P<0.01）。记录的不良事件有喉痉挛（25 例，1.2%）、气道装置血污（79 例，3.9%）、短暂神经损伤（2 例，0.1%）、一过性血管迷走性晕厥 1 例和 1 例声门血肿。
i-gel 是一种可靠的声门上气道装置，失败率<5%，提供高气道泄漏压力。男性、下颌骨脱位不良、牙齿状况不佳和年龄较大是与主要器械失败相关的危险因素。严重不良事件罕见。
