Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
PLoS One. 2022 Sep 9;17(9):e0273410. doi: 10.1371/journal.pone.0273410. eCollection 2022.
The incidence of atelectasis is high in patients undergoing general anesthesia. This may cause oxygenation impairment and further contribute to postoperative pulmonary complications (PPCs). As important airway management devices for general anesthesia, few studies have compared the effects of laryngeal mask airway (LMA) and endotracheal tube (ETT) on atelectasis. Additionally, lung ultrasound has been increasingly used for bedside atelectasis diagnosis. For the above considerations, this trial is designed to compare the effects of LMA and ETT on atelectasis assessed by lung ultrasound scores, further providing more powerful clinical evidence for perioperative respiratory management of non-laparoscopic elective lower abdominal surgery under general anesthesia.
This is a prospective, single-center, single-blind, randomized controlled trial. From July 2021 to July 2022, 180 patients undergoing elective non-laparoscopic lower abdominal surgery under general anesthesia will be recruited and randomly divided into the ETT and LMA groups at a ratio of 1:1. The primary outcome is the total atelectasis LUS of 12 lung regions 15 min after the establishment of the artificial airway. The total atelectasis LUS at the end of surgery and 30 min after extubation, oxygenation index, postoperative airway complications, PPCs, and length of stay will be analyzed as secondary indicators.
ClinicalTrials.gov identifier: ChiCTR1900020818. Registered on January 20, 2019. Registered with the name of "Laryngeal mask airway versus endotracheal tube for atelectasis." URL: https://www.chictr.org.cn/showproj.aspx?proj=35143.
全身麻醉患者的肺不张发生率较高,可能导致氧合受损,并进一步导致术后肺部并发症(PPCs)。喉罩气道(LMA)和气管内导管(ETT)作为全身麻醉的重要气道管理装置,很少有研究比较它们对肺不张的影响。此外,肺部超声已越来越多地用于床边肺不张诊断。基于上述考虑,本试验旨在比较肺超声评分评估的 LMA 和 ETT 对肺不张的影响,为全身麻醉下非腹腔镜择期下腹手术围手术期呼吸管理提供更有力的临床证据。
这是一项前瞻性、单中心、单盲、随机对照试验。从 2021 年 7 月至 2022 年 7 月,将招募 180 例全身麻醉下择期非腹腔镜下腹手术患者,并按 1:1 的比例随机分为 ETT 组和 LMA 组。主要结局是人工气道建立后 15 分钟 12 个肺区的总肺不张 LUS。分析总肺不张 LUS、手术结束时、拔管后 30 分钟的氧合指数、术后气道并发症、PPCs 和住院时间作为次要指标。
ClinicalTrials.gov 标识符:ChiCTR1900020818。于 2019 年 1 月 20 日注册。以“喉罩气道与气管内导管用于肺不张”的名义注册。网址:https://www.chictr.org.cn/showproj.aspx?proj=35143。