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Assessing a novel second generation laryngeal mask airway using the ‘ADEPT’ approach: results from the LMA® Protector™ observational study
Journal of Clinical Monitoring and Computing ( IF 2.2 ) Pub Date : 2022-09-05 , DOI: 10.1007/s10877-022-00910-5
A Ní Eochagáin 1 , V Athanassoglou 2 , A Cumberworth 2 , O Morris 1 , S Corbett 1 , H Jefferson 2 , E P O'Sullivan 1 , J J Pandit 2, 3, 4
Affiliation  

To address the problem of lack of clinical evidence for airway devices introduced to the market, the Difficult Airway Society (UK) developed an approach (termed ADEPT; Airway Device Evaluation Project Team) to standardise the model for device evaluation. Under this framework we assessed the LMA Protector, a second generation laryngeal mask airway. A total of 111 sequential adult patients were recruited and the LMA Protector inserted after induction of general anaesthesia. Effective insertion was confirmed by resistance to further distal movement, manual ventilation, and listening for gas leakage at the mouth. The breathing circuit was connected to the airway channel and airway patency confirmed with manual test ventilation at 20 cm H20 (water) pressure for 3 s. Data was collected in relation to the time for placement, intraoperative performance and postoperative performance of the airway device. Additionally, investigators rated the ease of insertion and adequacy of lung ventilation on a 5-point scale. The median (interquartile range [range]) time taken to insertion of the device was 31 (26–40[14–780]) s with the ability to ventilate after device insertion 100 (95% CI 96.7- 100)%. Secondary endpoints included one or more manoeuvres 60.3 (95% CI 50.6—69.5)% cases requiring to assist insertion; a median ease of insertion score of 4 (2–5[3–5]), and a median adequacy of ventilation score of 5 (5–5[4–5]). However, the first time insertion rate failure was 9.9% (95% CI 5.1—17.0%). There were no episodes of patient harm recorded, particularly desaturation. The LMA Protector appears suitable for clinical use, but an accompanying article discusses our reflections on the ADEPT approach to studying airway devices from a strategic perspective.



中文翻译:

使用“ADEPT”方法评估新型第二代喉罩气道:来自 LMA® Protector™ 观察性研究的结果

为了解决引入市场的气道设备缺乏临床证据的问题,困难气道协会 (UK) 开发了一种方法(称为 ADEPT;气道设备评估项目组)来标准化设备评估模型。在此框架下,我们评估了第二代喉罩气道 LMA Protector 总共招募了 111 名连续成年患者,并在全身麻醉诱导后插入 LMA 保护器。通过对进一步远端运动的阻力、手动通气和聆听口腔处的气体泄漏来确认有效插入。呼吸回路连接到气道通道,并通过 20 cm H 2手动测试通气确认气道通畅0(水)压力持续 3 秒。收集了与气道装置的放置时间、术中性能和术后性能相关的数据。此外,研究人员以 5 分制对插入的难易程度和肺通气的充分性进行了评分。插入装置所需的中位时间(四分位间距 [范围])为 31 (26–40[14–780]) 秒,装置插入后通气能力为 100 (95% CI 96.7-100)%。次要终点包括一次或多次操作 60.3 (95% CI 50.6—69.5)% 需要辅助插入的病例;轻松插入得分中位数为 4 (2–5[3–5]),通气充分性得分中位数为 5 (5–5[4–5])。然而,首次插入失败率为 9.9%(95% CI 5.1—17.0%)。没有记录到患者伤害事件,尤其是饱和度下降。

更新日期:2022-09-05
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