Endo Hiroyuki, Koike Tomoyuki, Obara Noriyuki, Hatta Waku, Masamune Atsushi
Department of Gastroenterology Japan Community Health Care Organization Sendai Hospital Miyagi Japan.
Division of Gastroenterology Tohoku University Graduate School of Medicine Miyagi Japan.
DEN Open. 2021 Sep 1;2(1):e36. doi: 10.1002/deo2.36. eCollection 2022 Apr.
Under the current pandemic situation of the coronavirus disease 2019 (COVID-19), we have newly developed a commercially available device named Endomask to prevent the diffusion of droplets from subjects undergoing esophagogastroduodenoscopy (EGD). Herein, we evaluate the efficacy and safety of the device, and also evaluate the stress of the device on the operators and the subjects of EGD.
The efficacy of the device was evaluated using an experimental model that simulated the environment of EGD. The safety of the device was evaluated clinically by means of measuring the oxygen saturation and the expiratory carbonic dioxide partial pressure of subjects with our device during EGD. The stress of the device on the operability of the endoscopists and the respiration of the subjects were evaluated using questionnaires.
In the experiments with Endomask, the percentage of the area with simulated droplets was significantly reduced compared to that without our device (median, 0.24% vs. 6.96%, = 0.009). The saturation of oxygen and the expiratory carbonic dioxide partial pressure of subjects with the device did not show significant change at any recording times. Neither the operators nor the subjects felt serious stress from examination with the device.
Endomask could remarkably and safely prevent the diffusion of droplets without serious stress. Endomask is expected to contribute to a reduction of the infectious risk of SARS-CoV-2 in endoscopy units during COVID-19 pandemic.
在2019年冠状病毒病（COVID-19）的当前大流行形势下，我们新开发了一种名为Endomask的商用设备，以防止接受食管胃十二指肠镜检查（EGD）的患者飞沫扩散。在此，我们评估该设备的有效性和安全性，并评估该设备对EGD操作人员和患者的压力。
使用模拟EGD环境的实验模型评估该设备的有效性。通过在EGD期间测量使用我们设备的患者的血氧饱和度和呼气二氧化碳分压，对该设备的安全性进行临床评估。使用问卷评估该设备对内镜医师可操作性和患者呼吸的压力。
在使用Endomask的实验中，与不使用我们设备的情况相比，模拟飞沫区域的百分比显著降低（中位数，0.24%对6.96%，P = 0.009）。使用该设备的患者的血氧饱和度和呼气二氧化碳分压在任何记录时间均未显示出显著变化。操作人员和患者在使用该设备进行检查时均未感到严重压力。
Endomask可以显著且安全地防止飞沫扩散，且不会造成严重压力。预计Endomask将有助于在COVID-19大流行期间降低内镜检查科室中SARS-CoV-2的感染风险。
