定制的正气道压力 (PAP) 治疗接口 (3DPiPPIn) 的临床影响:一个单位随机对照试验
Stephanie K Mansell1,2, Swapna Mandal3,2, Francesca Gowing2
1University College London, London, UK Stephanie.mansell.21@ucl.ac.uk.
Thorax
|January 27, 2026
概括
与标准口罩相比,针对睡眠呼吸暂停的定制3D打印口罩没有改善治疗结果. 需要进一步的研究来解决设计和制造方面的问题,才能实现定制接口的潜在好处.
科学领域:
- 医疗器械 医疗器械
- 睡眠医学 睡眠医学
- 生物医学工程 生物医学工程
背景情况:
- 阳性气道压力 (PAP) 治疗是睡眠呼吸障碍 (SDB) 的标准.
- 传统的口罩往往不适合,导致不有效的治疗.
- 定制的3D打印接口为改善舒适度和结果提供了潜在的解决方案.
研究的目的:
- 为了比较定制与常规口鼻接口在成年人阻塞性睡眠呼吸暂停 (OSA) 的临床有效性.
- 主要结局:6个月后剩余的呼吸暂停和呼吸暂停指数 (AHI).
- 二次结果:接口泄漏,治疗坚持,以及患者报告的症状.
主要方法:
- 随机对照试验涉及160名新诊断患有SDB的成年人.
- 使用3D面部扫描和3D打印创建了定制的界面.
- 使用量子回归来分析AHI数据,用于二次结果的后勤,量子和线性回归.
主要成果:
- 定制接口显示了增加AHI的趋势 (p=0.059).
- 与定制接口 (p<0.0001) 观察到显著更高的接口泄漏.
- 与定制接口 (p=0.04) 相关的合规性较低.
结论:
- 在这项试验中,定制的口腔和鼻腔接口并没有比传统接口更优越.
- 在未来的研究中需要解决设计和制造方面的限制.
- 需要进一步的研究来评估定制接口的潜在优势.
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