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临床试验/NCT04400734
NCT04400734Unknown不适用

Esophagogastroduodenoscopy (EGD) is an Aerosol-generating Procedure: Proof of Concept Study

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年5月7日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
The increase in particle counts of particle size (0.3um, 0.5um, 0.7um, 1um, 5um, 10um) during the procedure

研究概览

简要总结

The disease COVID-19 has been classified as pandemic by World Health Organisation (WHO) in March 2020. This poses a risk to healthcare workers. Whether esophagogastroduodenoscopy (EGD) is a aerosol-generating procedure (AGP) has brought controversy. Multiple international guidelines consider EGD as AGP based on expert consensus. No scientific data has been published regarding this. With a commercially available particle counter, we can differentiate the particle counts of different sizes in different areas of the endoscopy room. An increase from baseline particles of < 5um during or after the procedure would suggest that the procedure is an AGP. The baseline particle counts before and during the procedure are also recorded. The details of the procedure including procedure time and the use of sedation are also documented.

详细描述

The disease COVID-19 has been classified as pandemic by World Health Organisation (WHO) in March 2020. This poses a risk to healthcare workers. Whether esophagogastroduodenoscopy (EGD) is a aerosol-generating procedure (AGP) has brought controversy. Multiple international guidelines consider EGD as AGP based on expert consensus. No scientific data has been published regarding this. Currently, the term droplet is often taken to refer to droplets >5 microns (μm) in diameter that fall rapidly to the ground under gravity, and therefore are transmitted only over a limited distance (e.g. ≤1 m). In contrast, the term droplet nuclei refers to droplets ≤5 μm in diameter that can remain suspended in air for significant periods of time, allowing them to be transmitted over distances >1 metre. With a commercially available particle counter, we can differentiate the particle counts of different sizes in different areas of the endoscopy room. An increase from baseline particles of < 5um during or after the procedure would suggest that the procedure is an AGP. With the use of a commercial available particle counter, the number of particles of size (0.3um, 0.5um, 0.7um, 1um, 5um and 1um) are recorded. The baseline particle counts before and during the procedure are also recorded. The details of the procedure including procedure time and the use of sedation are also documented.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients undergoing EGD in the endoscopy unit of Prince of wales Hospital, Shatin, Hong Kong

排除标准

  • EGD cannot be completed due to patient's condition
  • Patients who are unstable and require extra medical attention
  • Patients who refuse
  • Patients who are not fit for consent

结局指标

主要结局

The increase in particle counts of particle size (0.3um, 0.5um, 0.7um, 1um, 5um, 10um) during the procedure

时间窗: during the procedure

次要结局

  • Use of sedation(during the procedure)
  • Use of continuous suction(during the procedure)
  • Procedure time(during the procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

CHAN SHANNON MELISSA

Assistant Professor

Chinese University of Hong Kong

研究点 (1)

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