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气管导管热软化对接受腺样体扁桃体切除术患儿围术期呼吸不良事件的影响:一项随机对照试验

Effect of Thermal Softening of Endotracheal Tubes on Perioperative Respiratory Adverse Events in Children Undergoing Adenotonsillectomy: A Randomized Controlled Trial.

临床研究咽喉科IF 2Q3

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中文摘要

背景: 围术期呼吸不良事件(PRAEs)是接受腺样体扁桃体切除术(AT)患儿发病的主要原因。聚氯乙烯气管导管(ETTs)的热软化已被提出可减少气道刺激,但其对儿科环境中PRAE发生率的影响仍不明确。我们旨在确定使用热软化ETTs是否能降低接受择期AT患儿的PRAE发生率。
方法: 这项前瞻性、随机对照试验纳入了254名计划接受择期AT的3-9岁儿童。参与者被随机分配至使用室温ETT(T1组)或预热至37°C的热软化ETT(T2组)进行插管。主要结局是从拔管至术后第二小时期间任何PRAE的发生——包括咳嗽、氧饱和度下降、喉痉挛或支气管痉挛。次要结局包括各PRAE组成部分的发生率以及围术期血流动力学和通气参数。使用多变量logistic回归评估PRAEs的独立预测因素。
结果: 两组基线特征相当。T2组总体PRAE发生率显著低于T1组(14.1% vs. 24.6%;p = 0.039)。T2组喉痉挛(2.3% vs. 8.7%;p = 0.029)和术后咳嗽(11.7% vs. 21.4%;p = 0.043)的发生率均显著更低。在氧饱和度下降、支气管痉挛、术中血流动力学参数或通气变量方面未检测到显著差异。多变量分析确定室温ETT使用(调整OR:2.29;95% CI:1.16-4.54)和较高的阻塞性睡眠呼吸暂停-18评分(调整OR:1.04;95% CI:1.01-1.07)为PRAE的独立预测因素。
结论: 插管前将ETTs加温至体温与接受AT患儿PRAEs的显著减少相关——尤其是喉痉挛和术后咳嗽。这种简单、低成本且无需额外设备或药物的方法可作为改善儿科气道安全的实用策略。需要多中心研究来证实这些发现并阐明潜在机制。
试验注册: ClinicalTrials.gov标识符:NCT06838260。

英文摘要

BACKGROUND: Perioperative respiratory adverse events (PRAEs) are a major source of morbidity in children undergoing adenotonsillectomy (AT). Thermal softening of polyvinyl chloride endotracheal tubes (ETTs) has been proposed to reduce airway irritation, yet its effect on PRAE incidence in the pediatric setting remains unclear. We sought to determine whether the use of thermally softened ETTs reduces PRAE incidence in children undergoing elective AT.
METHODS: This prospective, randomized controlled trial enrolled 254 children aged 3-9 years scheduled for elective AT. Participants were randomly assigned to intubation with either a room-temperature ETT (Group T1) or a thermally softened ETT pre-warmed to 37°C (Group T2). The primary outcome was the occurrence of any PRAE-including coughing, oxygen desaturation, laryngospasm, or bronchospasm-from extubation through the second postoperative hour. Secondary outcomes included the incidence of individual PRAE components and perioperative hemodynamic and ventilatory parameters. Independent predictors of PRAEs were evaluated using multivariable logistic regression.
RESULTS: Baseline characteristics were comparable between groups. The overall PRAE incidence was significantly lower in Group T2 than in Group T1 (14.1% vs. 24.6%; p = 0.039). Both laryngospasm (2.3% vs. 8.7%; p = 0.029) and postoperative coughing (11.7% vs. 21.4%; p = 0.043) occurred significantly less often in Group T2. No significant differences were detected in oxygen desaturation, bronchospasm, intraoperative hemodynamic parameters, or ventilatory variables. Multivariable analysis identified room-temperature ETT use (adjusted OR: 2.29; 95% CI: 1.16-4.54) and higher Obstructive Sleep Apnea-18 score (adjusted OR: 1.04; 95% CI: 1.01-1.07) as independent PRAE predictors.
CONCLUSIONS: Warming ETTs to body temperature before intubation was associated with a meaningful reduction in PRAEs-particularly laryngospasm and postoperative coughing-in children undergoing AT. This straightforward, low-cost approach that requires no additional equipment or pharmacological agents may serve as a practical strategy to improve pediatric airway safety. Multicenter studies are needed to confirm these findings and clarify the underlying mechanisms.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT06838260.