Department of Anesthesiology and Pain Therapy, Inselspital, University Hospital Bern, University of Bern, Bern, Switzerland.
Anesthesiology. 2011 Jul;115(1):102-10. doi: 10.1097/ALN.0b013e318219d619.
This prospective, randomized, controlled trial compares the performance of the pediatric i-gel (Intersurgical Ltd., Wokingham, United Kingdom) with the Ambu AuraOnce laryngeal mask (Ambu A/S, Ballerup, Denmark) in anesthetized and ventilated children.
With ethics committee approval and written informed consent, the authors included 208 children, aged 0-17 yr, scheduled for elective day-surgery under general anesthesia. The primary outcome variable was oropharyngeal leak pressure. Other outcome variables were first-attempt and overall success, time to sufficient ventilation, and adverse events.
Demographic data did not differ between groups. The leak pressure of the i-gel was significantly higher than the leak pressure of the Ambu (mean ± SD: 22 ± 5 cm H₂O vs. 19 ± 3, P < 0.01). First-attempt success was 91% for the i-gel and 93% for the Ambu (P = 0.50). Overall success was 93% for the i-gel versus 98% for the Ambu (P = 0.10). Successfully inserted i-gels needed to be secured by taping in place to ensure the seal in 44% (0% with the Ambu, P < 0.01). Insertion was faster with the Ambu (24 ± 8 s vs. 27 ± 11, P = 0.02). There were no major side effects with either device.
The leak pressure of the i-gel was statistically but not clinically significantly higher than the leak pressure of the Ambu. Time to insertion was longer with the i-gel. Both airway devices are suitable for positive pressure ventilation with high success rates in infants and children. Because the i-gel is prone to sliding out, it must be taped in place to avoid loss of the airway.
本前瞻性、随机、对照试验比较了小儿 i-gel（英国沃金汉的 Intersurgical Ltd.）和 Ambu AuraOnce 喉罩（丹麦 Ballerup 的 Ambu A/S）在麻醉和通气儿童中的性能。
在伦理委员会批准和书面知情同意的情况下，作者纳入了 208 名年龄 0-17 岁、拟在全身麻醉下择期行日间手术的儿童。主要结局变量为口咽漏压。其他结局变量为首次尝试和总成功率、达到充分通气的时间和不良事件。
两组患儿的人口统计学数据无差异。i-gel 的漏压显著高于 Ambu（均数±标准差：22±5cmH₂O 比 19±3cmH₂O，P<0.01）。i-gel 的首次尝试成功率为 91%，Ambu 为 93%（P=0.50）。i-gel 的总成功率为 93%，Ambu 为 98%（P=0.10）。为确保密封，需用胶带固定 i-gel 以确保密封，成功率为 44%（Ambu 为 0%，P<0.01）。Ambu 的插入速度更快（24±8s 比 27±11s，P=0.02）。两种装置均无严重不良反应。
i-gel 的漏压虽高于 Ambu，但无统计学差异，有临床意义。i-gel 的插入时间更长。两种气道装置均适用于小儿正压通气，成功率高。由于 i-gel 易滑出，必须用胶带固定以避免气道丢失。
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