Abstract：
The laryngeal mask airway (LMA) is commonly used for airway management. Cuff hyperinflation has been associated with complications, poor ventilation and increased risk of gastric insufflation. This study was designed to determine the best cuff inflation method of AuraOnce™ LMA during bronchoscopy and EBUS (Endobronquial Ultrasound Bronchoscopy) procedure. We designed a Randomized controlled, doble-blind, clinical trial to compare the efficacy and safety of three cuff inflation methods of AuraOnce™ LMA. 210 consenting patients scheduled for EBUS procedure under general anesthesia, using AuraOnce™ LMA were randomized into three groups depending on cuff insufflation: residual volume (RV), half of the maximum volume (MV), unchanged volume (NV). Parameters regarding intracuff pressure (IP), airway leak pressure (OLP), leakage volume (LV) were assessed, as well as postoperative complications (PC). 201 (95.7%) patients completed the study. Mean IP differed between groups (MV: 59.4 ± 32.4 cm H2O; RV: 75.1 ± 21.1 cm H2O; NV: 83.1 ± 25.5 cmH20; P < 0.01). The incidence of IP > 60 cmH2O was lower in the MV group compared to the other two (MV: 20/65(30.8%); RV:47/69 (68.1%); NV 48/67 (71.6%); p < 0.01). The insertion success rate was 89,6% (180/201) at first attempt, with no difference between groups (p = 0.38). No difference between groups was found either for OLP (p = 0.53), LV (p = 0.26) and PC (p = 0.16). When a cuff manometer is not available, a partial inflation of AuraOnce™ LMA cuff using MV method allows to control intracuff pressure, with no significant changes of OLP and LV compared to RV and NV insufflation method.Registration clinical trial: NCT04769791.
摘要：
喉罩气道(LMA)通常用于气道管理。袖带过度充气与并发症有关，通气不良和胃吹气风险增加。本研究旨在确定支气管镜检查和EBUS（超声支气管镜检查）过程中AuraOnce™LMA的最佳袖带充气方法。我们设计了一个随机对照,doble-blind,临床试验比较AuraOnce™LMA三种袖带充气方法的疗效和安全性。210名同意在全身麻醉下进行EBUS手术的患者，使用AuraOnce™LMA，根据袖带吹气将其随机分为三组：残余体积（RV），最大音量（MV）的一半，体积不变（NV）。关于内部压力（IP）的参数，气道渗漏压力(OLP),评估泄漏量（LV），以及术后并发症（PC）。201例（95.7%）患者完成研究。组间平均IP不同(MV:59.4±32.4cmH2O;RV:75.1±21.1cmH2O;NV:83.1±25.5cmH2O;P<0.01)。与其他两组相比，MV组IP>60cmH2O的发生率较低（MV：20/65（30.8％）；RV：47/69（68.1％）；NV48/67（71.6％）；p<0.01）。首次尝试插入成功率为89,6％（180/201），组间无差异(p=0.38)。OLP组间无差异(p=0.53)，LV(p=0.26)和PC(p=0.16)。当袖带压力计不可用时，使用MV方法对AuraOnce™LMA袖带进行部分充气，可以控制内部压力，与RV和NV吹气方法相比，OLP和LV无明显变化。注册临床试验：NCT04769791。
