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临床试验/NCT04399005
NCT04399005已完成不适用

The Efficacy Comparing Daily and After-each-case Room Disinfection in the Endoscopy Unit During the COVID-19 Pandemic.

The First Affiliated Hospital of Zhejiang Chinese Medical University1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2020年5月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
240
试验地点
1
主要终点
The number of colony-forming units (CFU)

研究概览

简要总结

The aim of our study was to evaluate the difference of effectiveness between daily and after-each-case room disinfection in the endoscopy unit during the COVID-19 pandemic.

详细描述

This study divided into 2 groups: daily room disinfection and after-each-case room disinfection. Each group was also subdivided into general anesthesia or non-general anesthesia gastroscopy, and with or without ventilation consultation room.

Samples collection include: operation unit air (six-stage sieve percussion air sampler for sampling, airflow rate 28.3L/min, sampling time 4 min); workstation's mouse (wiping sterile cotton for sampling); endoscopist's gown, control panel buttons, and patient's bed headboard (contact plate for sampling).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •All the cases received gastroscopy.

排除标准

  • •High-risk personal through contact history, symptoms, body temperature, COVID-19 virus nucleic acid testing and chest computed tomography (CT) scan.

研究组 & 干预措施

daily room disinfection

Experimental

Room disinfection was defined as the cleansing and disinfection of the surface of the facility, endoscopist's gown, and air in the endoscopy room after the examination. Specifically, sanitizing wipes wiped the surface of the facility one by one, containing quaternary ammonium salt, alcohol, and interfacial activator; the air disinfection machine continued for 30min of air disinfection. Daily room disinfection was defined as disinfection after completing 8 non-general anesthesia gastroscopy or 4 general anesthesia gastroscopy.

干预措施: daily room disinfection (Other)

after-each-case room disinfection

Experimental

Room disinfection was defined as the cleansing and disinfection of the surface of the facility, endoscopist's gown, and air in the endoscopy room after the examination. Specifically, sanitizing wipes wiped the surface of the facility one by one, containing quaternary ammonium salt, alcohol, and interfacial activator; the air disinfection machine continued for 30min of air disinfection. After-each-case room disinfection was defined as after completing each case.

干预措施: after-each-case room disinfection (Other)

结局指标

主要结局

The number of colony-forming units (CFU)

时间窗: 48 hours

The number of colony-forming units (CFU) of operation unit air, workstation's mouse, endoscopist's gown, control panel buttons, and patient's bed headboard.

Qualified rate of room disinfection

时间窗: 48 hours

The samples of workstation's mouse, control panel buttons and patient's bed headboard greater than 10 CFU/cm2, samples of endoscopist's gown greater than 200 CFU/suit, and samples of operation unit air greater than 500 CFU/m3 are deemed as an unacceptable level of bioburden.

次要结局

未报告次要终点

研究者

发起方
The First Affiliated Hospital of Zhejiang Chinese Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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