Abstract：
Correctly fitting N95 filtering facepiece respirators (FFRs) have become increasingly important in health care throughout the COVID-19 pandemic. We evaluated the hypothesis that personalized 3D-printed frames could improve N95 FFRs quantitative fit test pass rates and test scores in health care workers (HCWs). HCWs were recruited at a tertiary hospital in Adelaide, Australia (ACTRN 12622000388718). A mobile iPhone camera + app was used to produce 3D scans of volunteers\' faces, which were then imported into a software program to produce personalized virtual scaffolds suited to each user\'s face and their unique anatomical features. These virtual scaffolds were printed on a commercially available 3D printer, producing plastic (and then silicone-coated, biocompatible) frames that can be fitted inside existing hospital supply N95 FFR. The primary endpoint was improved pass rates on quantitative fit testing, comparing participants wearing an N95 FFR alone (control 1) with participants wearing the frame + N95 FFR (intervention 1). The secondary endpoint was the fit factor (FF) in these groups, and R-COMFI respirator comfort and tolerability survey scores. N = 66 HCWs were recruited. The use of intervention 1 increased overall fit test pass rates to 62/66 (93.8%), compared to 27/66 (40.9%) for controls. (OR for pFF pass 20.89 (95%CI: 6.77, 64.48, p < 0.001.) Average FF increased, with the use of intervention 1-179.0 (95%CI: 164.3,193.7), compared to 85.2 (95%CI: 70.4,100.0) with control 1. Pass rates and FF were improved with intervention 1 compared to control 1 for all stages of the fit-test: bending, talking, side-to-side, and up-down motion. (p < 0.001 all stages). Tolerability and comfort of the frame were evaluated with the validated R-COMFI respirator comfort score, showing improvement with the frame compared to N95 FFR alone (p = 0.006). Personalized 3D-printed face frames decrease leakage, improve fit testing pass rates and FF, and provide improved comfort compared to the N95 FFR alone. Personalized 3D-printed face frames represent a rapidly scalable new technology to decrease FFR leakage in HCW and potentially the wider population.
摘要：
在整个COVID-19大流行期间，正确安装N95过滤面罩呼吸器（FFR）在医疗保健中变得越来越重要。我们评估了以下假设：个性化的3D打印框架可以提高N95FFRs定量拟合测试通过率和医护人员（HCW）的测试分数。HCW是在阿德莱德的一家三级医院招募的，澳大利亚（ACTRN12622000388718）。手机iPhone摄像头+应用程序被用来制作志愿者面部的3D扫描，然后将其导入到软件程序中，以产生适合每个用户面部及其独特解剖特征的个性化虚拟支架。这些虚拟支架打印在市售的3D打印机上，生产塑料(然后涂硅胶，生物相容性)可安装在现有医院供应N95FFR内的框架。主要终点是定量拟合测试的通过率提高-比较仅佩戴N95FFR的参与者（对照1）与佩戴N95FFR的参与者（干预1）。次要终点是这些组中的拟合因子(FF)，和R-COMFI呼吸器舒适度和耐受性调查得分。N=66HCW被招募。干预措施1的使用将总体拟合测试通过率提高到62/66(93.8%)，对照组为27/66（40.9%）。（pFF通过20.89的OR值（95CI：6.77，64.48，P<0.001）。平均FF增加，使用干预1至179.0(95CI：164.3,193.7)，与对照1的85.2（95CI：70.4,100.0）相比。与对照1相比，在所有配合测试阶段，干预1的合格率和FF均得到改善：弯曲，说话,并排,和上下运动。(所有阶段P<0.001)。使用经过验证的R-COMFI呼吸器舒适度评分评估框架的耐受性和舒适度，与单独的N95FFR相比，帧显示出改善(P=0.006)。个性化3D打印面框减少泄漏，提高拟合测试通过率和FF，并且与单独的N95FFR相比提供改善的舒适性。个性化3D打印的面部镜架代表了一种可快速扩展的新技术，可减少HCW和潜在更广泛人群的FFR泄漏。
