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临床试验/NCT04864015
NCT04864015已完成不适用

COVID-19: a Study About Aerosol Formation During Gastroscopy With a Adjusted Mouthpiece for Droplet Reduction

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年3月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Generation of aerosol particles by esophagogastroduodenoscopy with the droplet reduction mouthpiece.

研究概览

简要总结

Measurement of aerosolisation during esophagogastroduodenoscopy (EGD) to compare two types of mouthpieces, conventional versus a new and commercially available one 'the droplet reduction mouthpiece B1'.

This new mouthpiece is considered to reduce droplet spreading during EGD and therefore could be a good option for use in COVID-19 positive patients.

详细描述

During esophagogastroduodenoscopy (EGD), a hard-plastic mouthpiece is used to protect the endoscope from being bitten and to enable its smooth insertion. In September 2020, the droplet reduction Mouthpiece "B1" (Mouthpiece MPC-ST GMDN:62534 Generic name: Endoscopic bite block, basic, reusable) was launched by Fujifilm Corporation, Tokyo, Japan and imported to Europe by Fujifilm Europe. The droplet reduction mouthpiece is used in the same way as the conventional mouthpiece but differs from current mouthpieces by the inclusion of a sponge rubber incorporated into the mouthpiece orifice, and a drape shield specifically created to catch and reduce the droplets emitted by the patient during upper gastrointestinal endoscopy. This newly developed mouthpiece is considered for application during routine endoscopy at our facility during the COVID-19 pandemic, helping to minimize the risk to health care workers and patients from becoming infected with COVID-19 and various other pathogens. However, there is a lack of scientific evidence on the amount of aerosol reduction with the modified mouthpiece when upper gastrointestinal (GI) endoscopy is being performed.

The aim of the present study is to quantify the generation of aerosols when performing upper GI endoscopy with the modified mouthpiece. The investigators intend to quantify the number of particles in the air near the patient. The duration of therapeutic upper gastrointestinal endoscopies can vary extremely. To avoid risk of imbalance in procedure durations, the investigational team is limiting the protocol to standard diagnostic EGDs. The investigators assume that aerosol generations during short procedures can be extrapolated to longer procedures and hence this should not invalidate the findings

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged >18 years old;
  • Male or female patients;
  • Patients undergoing elective standard diagnostic EGD;
  • Negative polymerase chain reaction (PCR) test on nasopharyngeal swab 24 or 48 hours prior to the test;
  • No anatomical deformity of nose and throat, no known diseases of nose and throat;
  • Signed informed consent

排除标准

  • Females who are pregnant or lactating.

结局指标

主要结局

Generation of aerosol particles by esophagogastroduodenoscopy with the droplet reduction mouthpiece.

时间窗: 4 months

Number of aerosols generated by EGD with the droplet reduction mouthpiece

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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