Clin Endosc.  2022 Mar;55(2):226-233. 10.5946/ce.2021.178-IDEN.

Preclinical Efficacy and Clinical Feasibility of a Novel Aerosol-Exposure Protection Mask for Esophagogastroduodenoscopy

Affiliations
  • 1Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan
  • 2Department of Gastroenterology, Tonan Hospital, Sapporo, Hokkaido, Japan
  • 3Shin Nippon Air Technologies, Tokyo, Japan

Abstract

Background/Aims
This study aimed to assess the efficacy of a novel aerosol-exposure protection (AP) mask in preventing coronavirus disease in healthcare professionals during upper gastrointestinal endoscopy and to evaluate its clinical feasibility.
Methods
In Study 1, three healthy volunteers volitionally coughed with and without the AP mask in a cleanroom. Microparticles were visualized and counted with a specific measurement system and compared with and without the AP mask. In Study 2, 30 patients underwent endoscopic resection with the AP mask covering the face, and the SpO2 was measured throughout the procedure.
Results
In Study 1, the median number of microparticles in volunteers 1, 2, and 3 with and without the AP mask was 8.5 and 110.0, 7.0 and 51.5, and 8.0 and 95.0, respectively (p<0.01). Using the AP mask, microparticles were reduced by approximately 92%. The median distances of microparticle scattering without the AP mask were 60, 0, and 68 in volunteers 1, 2, and 3, respectively. In Study 2, the mean SpO2 was 96.3%, and desaturation occurred in three patients.
Conclusion
The AP mask could provide protection from aerosol exposure and can be safely used for endoscopy in clinical practice.

Keyword

COVID-19; Gastrointestinal endoscopy; Personal protective equipment

Figure

  • Fig. 1. How to make aerosol-exposure protection (AP) mask. (A) Materials of the AP mask: an A4-sized plastic folder, string, and two pieces of gauze pad. (B) An A4-sized plastic folder was cut into a 12.5×12.5 cm square, and a 3.5 cm square was cut from its corner. (C) To insert the string, a small hole was made in the plastic folder and two pieces of gauze pad. (D) The gauze was placed on the edges of the plastic file holder with a string. (E) A healthy volunteer wearing the mask.

  • Fig. 2. Schematic illustration of experimental design in a cleanroom. (A) A healthy volunteer without the aerosol-exposure protection (AP) mask. (B) A healthy volunteer with the AP mask. (C) Schematic illustration of the experimental design in a cleanroom.

  • Fig. 3. Visualization of aerosol particles by light-emitting diode during simulated endoscopy.

  • Fig. 4. Droplets were identified inside the aerosol-exposure protection mask during endoscopic procedures.


Reference

1. World Health Organization. Coronavirus disease (COVID-2019) situation reports - 5 January 2021 [Internet]. Geneva: WHO;c2021. [cited 2021 Oct 12]. Available from: https://www.who.int/publications/m/item/weekly-epidemiological-update---5-January-2021.
2. Ortega R, Gonzalez M, Nozari A, Canelli R. Personal protective equipment and Covid-19. N Engl J Med. 2020; 382:e105.
3. The Lancet. COVID-19: protecting health-care workers. Lancet. 2020; 395:922.
4. Gralnek IM, Hassan C, Beilenhoff U, et al. ESGE and ESGENA position statement on gastrointestinal endoscopy and the COVID-19 pandemic. Endoscopy. 2020; 52:483–490.
5. Sagami R, Nishikiori H, Sato T, et al. Aerosols produced by upper gastrointestinal endoscopy: a quantitative evaluation. Am J Gastroenterol. 2021; 116:202–205.
6. Bhandari P, Subramaniam S, Bourke MJ, et al. Recovery of endoscopy services in the era of COVID-19: recommendations from an international Delphi consensus. Gut. 2020; 69:1915–1924.
7. Irisawa A, Furuta T, Matsumoto T, et al. Gastrointestinal endoscopy in the era of the acute pandemic of coronavirus disease 2019: recommendations by Japan Gastroenterological Endoscopy Society (Issued on April 9th, 2020). Dig Endosc. 2020; 32:648–650.
8. Repici A, Maselli R, Colombo M, et al. Coronavirus (COVID-19) outbreak: what the department of endoscopy should know. Gastrointest Endosc. 2020; 92:192–197.
9. Chiu PWY, Ng SC, Inoue H, et al. Practice of endoscopy during COVID-19 pandemic: position statements of the Asian Pacific Society for Digestive Endoscopy (APSDE-COVID statements). Gut. 2020; 69:991–996.
10. Hennessy B, Vicari J, Bernstein B, et al. Guidance for resuming GI endoscopy and practice operations after the COVID-19 pandemic. Gastrointest Endosc. 2020; 92:743–747.e1.
11. Sawano T, Kotera Y, Ozaki A, et al. Underestimation of COVID-19 cases in Japan: an analysis of RT-PCR testing for COVID-19 among 47 prefectures in Japan. QJM. 2020; 113:551–555.
12. Kawashima K, Abe S, Koga M, et al. Optimal selection of endoscopic resection in patients with esophageal squamous cell carcinoma: endoscopic mucosal resection versus endoscopic submucosal dissection according to lesion size. Dis Esophagus. 2021; 34:doaa096.
13. Mori G, Nonaka S, Oda I, et al. Novel strategy of endoscopic submucosal dissection using an insulation-tipped knife for early gastric cancer: nearside approach method. Endosc Int Open. 2015; 3:E425–E431.
14. Nonaka S, Kawaguchi Y, Oda I, et al. Safety and effectiveness of propofol-based monitored anesthesia care without intubation during endoscopic submucosal dissection for early gastric and esophageal cancers. Dig Endosc. 2015; 27:665–673.
15. Klompas M, Morris CA, Shenoy ES. Universal masking in the Covid-19 era. N Engl J Med. 2020; 383:e9.
16. van Doremalen N, Bushmaker T, Morris DH, et al. Aerosol and surface stability of SARS-CoV-2 as compared with SARS-CoV-1. N Engl J Med. 2020; 382:1564–1567.
17. Sagami R, Nishikiori H, Sato T, Murakami K. Endoscopic shield: barrier enclosure during the endoscopy to prevent aerosol droplets during the COVID-19 pandemic. VideoGIE. 2020; 5:445–448.
18. Leow VM, Mohamad IS, Subramaniam M. Use of aerosol protective barrier in a patient with impending cholangitis and unknown COVID-19 status undergoing emergency ERCP during COVID-19 pandemic. BMJ Case Rep. 2020; 13:e236918.
19. Sabbagh L, Huertas M, Preciado J, Sabbagh D. New protection barrier for endoscopic procedures in the era of pandemic COVID-19. Video-GIE. 2020; 5:614–617.
20. Sasaki S, Nishikawa J, Sakaida I. Use of a glove-covered mouthpiece during upper endoscopy to prevent COVID-19 transmission. Clin Endosc. 2021; 54:289–290.
21. Marchese M, Capannolo A, Lombardi L, Di Carlo M, Marinangeli F, Fusco P. Use of a modified ventilation mask to avoid aerosolizing spread of droplets for short endoscopic procedures during coronavirus COVID-19 outbreak. Gastrointest Endosc. 2020; 92:439–440.
22. Tian Q, Yan X, Shi R, et al. Endoscopic mask innovation and protective measures changes during the coronavirus disease-2019 pandemic: experience from a Chinese hepato-biliary-pancreatic unit. Dig Endosc. 2020; 32:1105–1110.
Full Text Links
  • CE
Actions
Cited
CITED
export Copy
Close
Share
  • Twitter
  • Facebook
Similar articles
Copyright © 2024 by Korean Association of Medical Journal Editors. All rights reserved.     E-mail: koreamed@kamje.or.kr