From the Jiangsu Province Key laboratory of Anaesthesiology, Xuzhou Medical University (XLi, XiuW, YZ, ZJ, XLv, XN, TL, XinW, SL), the Department of Anaesthesiology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou (LD, SL), the Department of Anaesthesiology, Dushuhu Public Hospital Affiliated to Soochow University, Suzhou (XiuW), the Department of Anaesthesiology, Changzhou Maternal and Child Healthcare Hospital, Changzhou (YZ), the Department of Anaesthesiology, Suqian First Hospital, Suqian, Jiangsu, China (LD).
Eur J Anaesthesiol. 2021 Mar 1;38(3):285-293. doi: 10.1097/EJA.0000000000001378.
Sore throat is a common complication after Laryngeal Mask Airway Supreme (SLMA) insertion.
The aim of this study was to determine whether a new SLMA insertion technique (not removing the pilot tube blocker before insertion) lowers the incidence of sore throat in the postanaesthesia care unit (PACU).
A prospective, single-centre, parallel randomised controlled trial.
Operating room and PACU at a hospital in China from June to September 2019.
Four hundred and eight patients aged 18 to 65 years with American Society of Anaesthesiologists physical status class I or II who were scheduled for elective surgery requiring anaesthesia and SLMA insertion.
Leaving the blocker at the end of the pilot tube in situ (this blocker keeps the valve open and the balloon remains partially inflated but will deflate with pressure) or removing the blocker and actively deflating the cuff before SLMA insertion.
The primary outcome was the incidence of postoperative sore throat in the PACU. The secondary outcomes included sore throat severity (Prince Henry Hospital Pain Score), first-attempt success rate, ease of insertion, time to successful SLMA insertion, oropharyngeal leak pressure, grade of view on fibreoptic bronchoscopy (indicating the accuracy of SLMA positioning) and adverse events.
The incidence of sore throat was 33/204 (16.2%) in the nonremoval group, and 65/204 (31.9%) in the removal group (P < 0.001). The first-attempt success rate was 174/204 (85.3%) in the nonremoval group and 150/204 (73.76%) in the removal group (P = 0.003; relative risk 1.160, 95% CI 1.049 to 1.282). The Kaplan--Meier curves showed that the insertion time in the nonremoval group was shorter (log-rank P = 0.01).
The new insertion technique, leaving the blocker attached to the end of the pilot balloon, resulted in a reduced incidence and severity of postoperative sore throat in the PACU, and an improved first-attempt success rate and the accuracy of SLMA positioning.
Chinese Clinical Trial Registry identifier: ChiCTR1900023022.
喉罩 Supreme（SLMA）插入后咽喉痛是常见的并发症。
本研究旨在确定一种新的 SLMA 插入技术（在插入前不取出导丝管阻塞器）是否会降低麻醉后护理单元（PACU）中咽喉痛的发生率。
前瞻性、单中心、平行随机对照试验。
中国一家医院的手术室和 PACU，时间为 2019 年 6 月至 9 月。
年龄 18 至 65 岁，ASA 身体状况 I 或 II 级，拟行全身麻醉和 SLMA 插入的择期手术。
将阻塞器留在导丝管末端（该阻塞器保持阀门打开，球囊部分充气但会在压力下放气）或在插入 SLMA 之前取出阻塞器并主动放气。
主要观察结果是 PACU 术后咽喉痛的发生率。次要观察结果包括咽喉痛严重程度（Prince Henry 医院疼痛评分）、首次尝试成功率、插入难易程度、成功插入 SLMA 的时间、口咽漏压、纤维支气管镜检查的观察等级（表示 SLMA 定位的准确性）和不良事件。
非去除组咽喉痛发生率为 33/204（16.2%），去除组为 65/204（31.9%）（P<0.001）。非去除组首次尝试成功率为 174/204（85.3%），去除组为 150/204（73.76%）（P=0.003；相对风险 1.160，95%CI 1.049 至 1.282）。Kaplan-Meier 曲线显示，非去除组的插入时间更短（对数秩 P=0.01）。
新的插入技术，将阻塞器附着在导丝管末端的气球上，可降低 PACU 术后咽喉痛的发生率和严重程度，并提高首次尝试成功率和 SLMA 定位的准确性。
中国临床试验注册中心标识符：ChiCTR1900023022。
