唇裂和/或腭裂儿童全身麻醉的气道管理与麻醉干预：系统评价与荟萃分析方案

文献信息

中文摘要

背景： 唇裂和/或腭裂儿童由于上气道和颅面解剖结构改变，在围手术期气道管理方面可能面临独特挑战。这些儿童经常接受需要全身麻醉和气道器械操作的外科手术。已有多种气道管理和麻醉技术被评估用于促进气管插管并减少围手术期气道并发症，但来自随机对照试验的比较证据尚未被系统评价。
方法： 本系统评价与荟萃分析将纳入涉及18岁以下唇裂和/或腭裂儿童接受全身麻醉的随机对照试验。符合条件的研究将在两组唇裂/腭裂患者之间比较气道管理的替代技术或装置或其他麻醉策略。主要结局为气管插管困难。若定义差异较大，结局将分别分析或以叙述性方式综合。次要结局将包括面罩通气困难、氧饱和度下降、气道梗阻、喉镜暴露困难、首次插管成功、插管尝试次数、成功插管或建立气道的时间、插管失败以及其他围手术期气道或呼吸不良事件。两名评价员将独立筛选随机对照试验、提取数据并评估偏倚风险。偏倚风险将使用Cochrane偏倚风险2工具评估。在临床合适的情况下将进行随机效应荟萃分析。二分类结局将使用风险比，连续结局将使用均数差或标准化均数差。重要结局的证据确定性将使用推荐分级的评估、制定与评价（GRADE）方法评估。
注册与评价状态： 本评价已于2026年3月10日在PROSPERO前瞻性注册（CRD420261326076）。全文筛选和数据提取正在进行中，尚未完成。方案修订已在PROSPERO中透明记录。

英文摘要

BACKGROUND: Children with cleft lip and/or palate may present unique challenges during perioperative airway management because of altered upper-airway and craniofacial anatomy. These children frequently undergo surgical procedures requiring general anaesthesia and airway instrumentation. Several airway-management and anaesthetic techniques have been evaluated to facilitate tracheal intubation and reduce perioperative airway complications, but the comparative evidence from randomised controlled trials has not been systematically evaluated.
METHODS: This systematic review and meta-analysis will include randomised controlled trials involving children < 18 years with cleft lip and/or palate undergoing general anaesthesia. Eligible studies will compare alternative techniques or devices for airway management or other anaesthetic strategies between two groups of cleft lip/palate patients. The primary outcome will be difficulty in tracheal intubation. Where definitions vary substantially, outcomes will be analysed separately or synthesised narratively. Secondary outcomes will include difficult mask ventilation, oxygen desaturation, airway obstruction, difficult laryngoscopy, first-attempt intubation success, number of intubation attempts, time to successful intubation or airway establishment, failed intubation and other perioperative airway or respiratory adverse events. Two reviewers will independently select RCTs, extract data and assess risk of bias. Risk of bias will be evaluated using the Cochrane Risk of Bias 2 tool. Random-effects meta-analysis will be performed where clinically appropriate. Risk ratios will be used for dichotomous outcomes and mean differences or standardized mean differences for continuous outcomes. Certainty of evidence for important outcomes will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
REGISTRATION AND REVIEW STATUS: The review was prospectively registered in PROSPERO on 10 March 2026 (CRD420261326076). Full-text screening and data extraction are ongoing and not yet complete. Protocol amendments are documented transparently in PROSPERO.