Medical Device Innovation Center, National Cheng Kung University, No. 138, Shengli Rd., North District, Tainan, 70403, Taiwan.
Department of Emergency Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Biomed Eng Online. 2022 Sep 5;21(1):62. doi: 10.1186/s12938-022-01027-1.
Aerosols and droplets are the transmission routes of many respiratory infectious diseases. The COVID-19 management guidance recommends against the use of nebulized inhalation therapy directly in the emergency room or in an ambulance to prevent possible viral transmission. The three-dimensional printing method was used to develop an aerosol inhalation treatment mask that can potentially prevent aerosol dispersion. We conducted this utility validation study to understand the practicability of this new nebulizer mask system.
The fit test confirmed that the filter can efficiently remove small particles. The different locations of the mask had an excellent fit with a high pressure making a proper face seal usability. The full-face mask appeared to optimize filtration with pressure and is an example of materials that perform well for improvised respiratory protection using this design. The filtering effect test confirmed that the contamination of designated locations could be protected when using the mask with filters. As in the clinical safety test, a total of 18 participants (10 [55.6%] females; aged 33.1 ± 0.6 years) were included in the final analysis. There were no significant changes in SPO, EtCO, HR, SBP, DBP, and RR at the beginning, 20th, 40th, or 60th minutes of the test (all p >.05). The discomfort of wearing a mask increased slightly after time but remained within the tolerable range. The vision clarity score did not significantly change during the test. The mask also passed the breathability test.
The results of our study showed that this mask performed adequately in the fit test, the filtering test, and the clinical safety test. The application of a full-face mask with antiviral properties, together with the newly designed shape of a respirator that respects the natural curves of a human face, will facilitate the production of personal protective equipment with a highly efficient filtration system.
We conducted three independent tests in this validation study: (1) a fit test to calculate the particle number concentration and its association with potential leakage; (2) a filtering effect test to verify the mask's ability to contain aerosol spread; and (3) a clinical safety test to examine the clinical safety, comfortableness, and visual clarity of the mask.
气溶胶和飞沫是许多呼吸道传染病的传播途径。COVID-19 管理指南建议在急诊室或救护车内避免直接使用雾化吸入疗法，以防止可能的病毒传播。本研究采用三维打印方法开发了一种气溶胶吸入治疗面罩，以防止气溶胶扩散。我们进行了这项实用性验证研究，以了解这种新型雾化器面罩系统的实用性。
贴合度测试证实了该过滤器能够有效去除小颗粒。口罩的不同位置与高气压配合良好，形成了适当的面部密封，具有良好的可用性。全脸面罩似乎通过压力优化了过滤效果，是使用这种设计进行临时呼吸保护时表现良好的材料的一个例子。过滤效果测试证实，使用带过滤器的口罩可以保护指定位置免受污染。与临床安全性测试一样，共有 18 名参与者（10 名[55.6%]女性；年龄 33.1±0.6 岁）纳入最终分析。在测试的第 0、20、40 和 60 分钟时，SPO、EtCO、HR、SBP、DBP 和 RR 均无明显变化（均 P>.05）。随着时间的推移，佩戴口罩的不适感略有增加，但仍在可耐受范围内。测试过程中视力清晰度评分无明显变化。口罩还通过了透气性测试。
本研究结果表明，该口罩在贴合度测试、过滤测试和临床安全性测试中表现良好。具有抗病毒性能的全脸面罩的应用，以及尊重人脸自然曲线的新型呼吸器形状设计，将有助于生产具有高效过滤系统的个人防护设备。
本验证研究共进行了三项独立测试：（1）贴合度测试，计算颗粒数浓度及其与潜在泄漏的关系；（2）过滤效果测试，验证口罩对气溶胶扩散的控制能力；（3）临床安全性测试，检查口罩的临床安全性、舒适性和视觉清晰度。
