Prim Teresa, Brogly Nicolas, Guasch Emilia, Díez Jesús, Gilsanz Fernando
Department of Anesthesiology and Reanimation Surgical Intensive Care, Hospital Universitario La Paz /Cantoblanco/Carlos III, Madrid, Spain.
Department of Biostatistics, Hospital Universitario La Paz, Pº de la Castellana, 261, Madrid, 28046, Spain.
J Clin Monit Comput. 2024 Feb;38(1):37-45. doi: 10.1007/s10877-023-01061-x. Epub 2023 Aug 4.
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 HO; RV: 75.1 ± 21.1 cm HO; NV: 83.1 ± 25.5 cmH0; P < 0.01). The incidence of IP > 60 cmHO 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.
喉罩气道（LMA）常用于气道管理。套囊过度充气与并发症、通气不良及胃内充气风险增加有关。本研究旨在确定在支气管镜检查和超声支气管镜（EBUS）操作过程中AuraOnce™ LMA的最佳套囊充气方法。我们设计了一项随机对照双盲临床试验，以比较AuraOnce™ LMA三种套囊充气方法的有效性和安全性。210例计划在全身麻醉下使用AuraOnce™ LMA进行EBUS操作的患者，根据套囊充气情况随机分为三组：残余容积（RV）组、最大容积的一半（MV）组、容积不变（NV）组。评估了套囊内压（IP）、气道漏气压力（OLP）、漏气量（LV）等参数以及术后并发症（PC）。201例（95.7%）患者完成了研究。各组间平均IP存在差异（MV组：59.4±32.4cmH₂O；RV组：75.1±21.1cmH₂O；NV组：83.1±25.5cmH₂O；P＜0.01）。与其他两组相比，MV组IP＞60cmH₂O的发生率更低（MV组：20/65（30.8%）；RV组：47/69（68.1%）；NV组48/67（71.6%）；p＜0.01）。首次尝试插入成功率为89.6%（180/201），各组间无差异（p = 0.38）。在OLP（p = 0.53）、LV（p = 0.26）和PC（p = 0.16）方面，各组间也未发现差异。当没有套囊压力计可用时，使用MV方法对AuraOnce™ LMA套囊进行部分充气可控制套囊内压，与RV和NV充气方法相比，OLP和LV无显著变化。临床试验注册号：NCT04769791。
