与用于阻塞性睡眠呼吸暂停的装置辅助状腺和舌头基部悬浮相关的不良事件
Jane Y Tong1, Wiktoria A Gocal1, Sunny J Haft1
1Department of Otorhinolaryngology - Head and Neck Surgery, University of Maryland, School of Medicine, Baltimore, MD, United States of America.
American journal of otolaryngology
|March 13, 2024
概括
感染是用于阻塞性睡眠呼吸暂停 (OSA) 的雄腺和舌头基悬浮中最常见的不良事件. 外科医生的培训可以减少操作员错误,导致像破螺丝这样的并发症.
科学领域:
- 睡眠医学 睡眠医学
- 手术创新 在外科创新.
- 医疗器械安全 医疗器械安全
背景情况:
- 阻塞性睡眠呼吸暂停 (OSA) 是一种常见的疾病.
- 状腺和舌基悬浮是OSA治疗的外科选择.
- 了解与设备相关的不良事件对于患者安全至关重要.
研究的目的:
- 为了总结与状腺和舌头底部悬挂系统 (AIRvance和AIRLIFT) 相关的设备不良事件.
- 分析大量患者队列中报告的并发症的频率和类型.
主要方法:
- 使用了美国食品和药物管理局的MAUDE数据库.
- 从2012年到2022年查询与状腺或舌基悬浮相关的不良事件.
- 识别和分类了77个报告的不良事件.
主要成果:
- 确定了77个不良事件;术后并发症更为频繁 (66.2%).
- 感染 (29.9%),断螺丝 (19.5%) 和疼痛 (13.0%) 是最常见的不良事件.
- 10例感染需要排水/除菌;12例感染需要装置扩展.
结论:
- 感染是最常见的不良事件,可能需要装置扩展.
- 操作人员的错误导致了诸如破裂的螺丝和裂等并发症.
- 加强外科医生培训和标准化报告可以改善OSA手术的安全性和治疗比较.
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