Protocol of a randomised controlled trial to assess medical staff’s inhalation exposure to infectious particles exhaled by patients during oesophagogastroduodenoscopy and the efficacy of surgical masks in this context
Background Aerosol-generating procedures such as oesophagogastroduodenoscopy (OGD) result in infectious particles being exhaled by patients. This substantially increases the medical staff’s risk of occupational exposure to pathogenic particles via airway inhalation and facial mucosal deposition. Inf...
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| Format: | Article |
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BMJ Publishing Group
2023-02-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/2/e068291.full |
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| author | Li Liu Aiming Yang Xi Wu Shengyu Zhang Zhiyu Yan Yuheng Zhang Mengjie Duan |
| author_facet | Li Liu Aiming Yang Xi Wu Shengyu Zhang Zhiyu Yan Yuheng Zhang Mengjie Duan |
| author_sort | Li Liu |
| collection | DOAJ |
| description | Background Aerosol-generating procedures such as oesophagogastroduodenoscopy (OGD) result in infectious particles being exhaled by patients. This substantially increases the medical staff’s risk of occupational exposure to pathogenic particles via airway inhalation and facial mucosal deposition. Infectious particles are regarded as a key route of transmission of SARS-CoV-2 and, thus, represents a major risk factor for medical staff during the ongoing COVID-19 pandemic. There is a need for quantitative evidence on medical staff’s risk of multiroute exposure to infectious particles exhaled by patients during OGD to enable the development of practical, feasible and economical methods of risk-reduction for use in OGD and related procedures. This randomised controlled trial (RCT)—Personal protective EquiPment intervention TrIal for oesophagogastroDuodEnoscopy (PEPTIDE)—aims to establish a state-of-the-art protocol for quantifying the multiroute exposure of medical staff to infectious particles exhaled by patients during real OGD procedures.Method and analysis PEPTIDE will be a prospective, two-arm, RCT using quantitative methods and will be conducted at a tertiary hospital in China. It will enrol 130 participants (65 per group) aged over 18. The intervention will be an anthropomorphic model with realistic respiratory-related morphology and respiratory function that simulates a medical staff member. This model will be used either without or with a surgical mask, depending on the group allocation of a participant, and will be placed beside the participants as they undergo an OGD procedure. The primary outcome will be the anthropomorphic model’s airway dosage of the participants’ exhaled infectious particles with or without a surgical mask, and the secondary outcome will be the anthropomorphic model’s non-surgical mask-covered facial mucosa dosage of the participants’ exhaled infectious particles. Analyses will be performed in accordance with the type of data collected (categorical or quantitative data) using SPSS (V.26.0) and RStudio (V.1.3.959).Ethics and dissemination Ethical approval for this RCT was obtained from the Ethics Committee of Peking Union Medical College Hospital (ZS-3377). All of the potential participants who agree to participate will provide their written informed consent before they are enrolled. The results will be disseminated through presentations at national and international conferences and publications in peer-reviewed journals.Trial registration number NCT05321056. |
| format | Article |
| id | doaj-art-3676d287db8847bdb7fa35e3be09ec8e |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2023-02-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-3676d287db8847bdb7fa35e3be09ec8e2025-08-20T03:16:19ZengBMJ Publishing GroupBMJ Open2044-60552023-02-0113210.1136/bmjopen-2022-068291Protocol of a randomised controlled trial to assess medical staff’s inhalation exposure to infectious particles exhaled by patients during oesophagogastroduodenoscopy and the efficacy of surgical masks in this contextLi Liu0Aiming Yang1Xi Wu2Shengyu Zhang3Zhiyu Yan4Yuheng Zhang5Mengjie Duan61 Department of Urology, Zhongshan Hospital, Fudan University, Shanghai, ChinaDepartment of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaDepartment of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Peking Union Medical College Hospital, Beijing, ChinaDepartment of Gastroenterology, Peking Union Medical College Hospital, Dongcheng-qu, Beijing, ChinaDepartment of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, ChinaDepartment of Plastic and Burn Surgery, Second Affiliated Hospital of Air Force Medical University, Xi`an, Shaanxi, ChinaDepartment of Building Science, Tsinghua University, Beijing, ChinaBackground Aerosol-generating procedures such as oesophagogastroduodenoscopy (OGD) result in infectious particles being exhaled by patients. This substantially increases the medical staff’s risk of occupational exposure to pathogenic particles via airway inhalation and facial mucosal deposition. Infectious particles are regarded as a key route of transmission of SARS-CoV-2 and, thus, represents a major risk factor for medical staff during the ongoing COVID-19 pandemic. There is a need for quantitative evidence on medical staff’s risk of multiroute exposure to infectious particles exhaled by patients during OGD to enable the development of practical, feasible and economical methods of risk-reduction for use in OGD and related procedures. This randomised controlled trial (RCT)—Personal protective EquiPment intervention TrIal for oesophagogastroDuodEnoscopy (PEPTIDE)—aims to establish a state-of-the-art protocol for quantifying the multiroute exposure of medical staff to infectious particles exhaled by patients during real OGD procedures.Method and analysis PEPTIDE will be a prospective, two-arm, RCT using quantitative methods and will be conducted at a tertiary hospital in China. It will enrol 130 participants (65 per group) aged over 18. The intervention will be an anthropomorphic model with realistic respiratory-related morphology and respiratory function that simulates a medical staff member. This model will be used either without or with a surgical mask, depending on the group allocation of a participant, and will be placed beside the participants as they undergo an OGD procedure. The primary outcome will be the anthropomorphic model’s airway dosage of the participants’ exhaled infectious particles with or without a surgical mask, and the secondary outcome will be the anthropomorphic model’s non-surgical mask-covered facial mucosa dosage of the participants’ exhaled infectious particles. Analyses will be performed in accordance with the type of data collected (categorical or quantitative data) using SPSS (V.26.0) and RStudio (V.1.3.959).Ethics and dissemination Ethical approval for this RCT was obtained from the Ethics Committee of Peking Union Medical College Hospital (ZS-3377). All of the potential participants who agree to participate will provide their written informed consent before they are enrolled. The results will be disseminated through presentations at national and international conferences and publications in peer-reviewed journals.Trial registration number NCT05321056.https://bmjopen.bmj.com/content/13/2/e068291.full |
| spellingShingle | Li Liu Aiming Yang Xi Wu Shengyu Zhang Zhiyu Yan Yuheng Zhang Mengjie Duan Protocol of a randomised controlled trial to assess medical staff’s inhalation exposure to infectious particles exhaled by patients during oesophagogastroduodenoscopy and the efficacy of surgical masks in this context BMJ Open |
| title | Protocol of a randomised controlled trial to assess medical staff’s inhalation exposure to infectious particles exhaled by patients during oesophagogastroduodenoscopy and the efficacy of surgical masks in this context |
| title_full | Protocol of a randomised controlled trial to assess medical staff’s inhalation exposure to infectious particles exhaled by patients during oesophagogastroduodenoscopy and the efficacy of surgical masks in this context |
| title_fullStr | Protocol of a randomised controlled trial to assess medical staff’s inhalation exposure to infectious particles exhaled by patients during oesophagogastroduodenoscopy and the efficacy of surgical masks in this context |
| title_full_unstemmed | Protocol of a randomised controlled trial to assess medical staff’s inhalation exposure to infectious particles exhaled by patients during oesophagogastroduodenoscopy and the efficacy of surgical masks in this context |
| title_short | Protocol of a randomised controlled trial to assess medical staff’s inhalation exposure to infectious particles exhaled by patients during oesophagogastroduodenoscopy and the efficacy of surgical masks in this context |
| title_sort | protocol of a randomised controlled trial to assess medical staff s inhalation exposure to infectious particles exhaled by patients during oesophagogastroduodenoscopy and the efficacy of surgical masks in this context |
| url | https://bmjopen.bmj.com/content/13/2/e068291.full |
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