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比较 Ambu®AuraGain™ 喉罩在仰卧位和俯卧位手术儿童中的临床性能 - 一项前瞻性、非劣效性临床试验。

Comparison of the clinical performance of the Ambu®AuraGain™ laryngeal mask in children undergoing surgery in the supine and prone position - A prospective, non-inferiority clinical trial.

机构信息

Department of Anesthesiology and Pain Medicine, Severance Hospital, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodamungu, Seoul 03722, Republic of Korea.

Biostatistics Collaboration Unit, Department of Biomedical Systems Informatics, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodamungu, Seoul 03722, Republic of Korea.

出版信息

J Clin Anesth. 2024 Dec;99:111652. doi: 10.1016/j.jclinane.2024.111652. Epub 2024 Oct 11.

DOI:10.1016/j.jclinane.2024.111652
PMID:39395249
Abstract

STUDY OBJECTIVE

Reports are limited regarding supraglottic airway (SGA) usage in children in the prone position. This study aimed to compare the clinical performance of the Ambu®AuraGain™, a 2nd generation SGA, in children undergoing surgery in the prone and supine positions. We hypothesized that oropharyngeal leak pressure (OLP) in the prone position would not be inferior to that in the supine position.

DESIGN

Single-center, prospective, non-randomized controlled study.

SETTING

Operating room.

PATIENTS

One hundred and twenty-six children, American Society of Anesthesiologists (ASA) physical status I-III, aged 2-12 years, undergoing elective surgery for 2 h or less in the supine or prone position.

INTERVENTIONS

After induction of general anesthesia and insertion of the AuraGain, patients were positioned either supine or prone, according to type of surgery.

MEASUREMENTS

OLP immediately after surgical positioning was measured as the primary outcome. The anatomical position of the AuraGain was evaluated using a flexible fiberoptic bronchoscope (Olympus LF-DP Tracheal Intubation Fiberscope, Melville, New York, USA). Airway maneuvers performed during placement and maintenance of the AuraGain and airway-related adverse events were recorded.

MAIN FINDINGS

The mean difference in OLP immediately after positioning was 0.048 cmHO (95 % confidence interval: -1.521 to 1.616), and the non-inferiority hypothesis was accepted (P < 0.001 for non-inferiority). There was no significant difference in the anatomical position of the SGA and adverse events. Airway maneuvers were significantly more commonly performed during placement in the Prone group compared to the Supine group (51 (81.0 %) vs. 3 (4.8 %), respectively; P < 0.001).

CONCLUSION

OLP when using AuraGain in the prone position in children was not inferior to that in the supine position. This suggests that the AuraGain may be an effective option for children undergoing short surgical procedures in the prone position.

摘要

研究目的

关于在俯卧位儿童中使用声门上气道(SGA)的报告有限。本研究旨在比较第二代 SGA 安必成®AuraGain 在俯卧位和仰卧位手术患儿中的临床性能。我们假设俯卧位时的咽腔漏气压(OLP)不会低于仰卧位。

设计

单中心、前瞻性、非随机对照研究。

地点

手术室。

患者

126 名美国麻醉医师协会(ASA)身体状况 I-III 级、年龄 2-12 岁的儿童,行 2 小时或更短时间的仰卧位或俯卧位择期手术。

干预措施

全身麻醉诱导和 AuraGain 插入后,根据手术类型将患者置于仰卧位或俯卧位。

测量

作为主要结局,测量手术体位后立即的 OLP。使用柔性纤维支气管镜(奥林巴斯 LF-DP 气管插管纤维镜,美国纽约州梅尔维尔)评估 AuraGain 的解剖位置。记录放置和维持 AuraGain 期间的气道操作和与气道相关的不良事件。

主要发现

定位后 OLP 的平均差值为 0.048cmH2O(95%置信区间:-1.521 至 1.616),接受非劣效性假设(非劣效性 P<0.001)。SGA 的解剖位置和不良事件无显著差异。与仰卧位组相比,俯卧位组在放置期间气道操作明显更常见(分别为 51(81.0%)对 3(4.8%);P<0.001)。

结论

在儿童俯卧位使用 AuraGain 时,OLP 不劣于仰卧位。这表明 AuraGain 可能是俯卧位行短时间手术患儿的有效选择。

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