Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
BMJ Open. 2023 Feb 28;13(2):e068291. doi: 10.1136/bmjopen-2022-068291.
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.
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).
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.
NCT05321056.
产生气溶胶的程序，如食管胃十二指肠镜检查（OGD），会导致患者呼出感染性颗粒。这大大增加了医务人员通过气道吸入和面部黏膜沉积而接触到致病颗粒的职业暴露风险。感染性颗粒被认为是 SARS-CoV-2 的主要传播途径之一，因此，在当前 COVID-19 大流行期间，代表了医务人员的一个主要危险因素。 需要有定量证据证明医务人员在 OGD 期间通过患者呼出的感染性颗粒的多途径暴露风险，以便为 OGD 和相关程序开发实用、可行和经济的降低风险方法。 本随机对照试验（RCT）-个人防护设备干预 OGD 试验（PEPTIDE）旨在建立一种定量评估医务人员在实际 OGD 过程中接触患者呼出的感染性颗粒的多途径暴露的最先进方案。
PEPTIDE 将是一项前瞻性、双臂、RCT，使用定量方法，并在中国的一家三级医院进行。它将招募 130 名年龄在 18 岁以上的参与者（每组 65 名）。干预措施将是一个具有逼真呼吸相关形态和呼吸功能的拟人模型，模拟医务人员。该模型将根据参与者的分组情况，要么不使用手术口罩，要么使用手术口罩，放置在参与者旁边，让他们进行 OGD 程序。主要结局将是参与者呼出的感染性颗粒在使用或不使用手术口罩的情况下，在拟人模型的气道剂量，次要结局将是参与者呼出的感染性颗粒在拟人模型的非手术口罩覆盖的面部黏膜剂量。分析将根据收集的数据类型（分类数据或定量数据）使用 SPSS（V.26.0）和 RStudio（V.1.3.959）进行。
本 RCT 已获得北京协和医学院医院伦理委员会的批准（ZS-3377）。所有同意参与的潜在参与者在被纳入之前都将提供书面知情同意书。结果将通过在国内外会议上的演讲和在同行评议期刊上的发表来传播。
NCT05321056。
