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临床试验/NCT04749121
NCT04749121已完成不适用

Impact of Ultraviolet Germicidal Irradiation on the New Silicone Half-Piece Elastometric Respirators (VJR-NMU) Respirator Performances, Structural Integrity and Sterility During COVID -19 Pandemic:

Bangkok Metropolitan Administration Medical College and Vajira Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Fit test

研究概览

简要总结

Since the innovation of our new half- elastometric half-piece respirator, this type of FFR has been used widely in our country. Decontamination methods including ultraviolet C (UVC) germicidal irradiation and 70% alcohol have been implemented to decontaminate the respirator. We than examined inactivation potential for the Porcine epidemic diarrhea virus (PEDV), numerous bacterial strains ,mostly skin-derived after the decontamination process.To enable rigorous integrity after repeated decontamination process, fit test by the Bitrex test ,tensile strength and elongation at break were also evaluated. Our results showed that the UVC at the dose of 3 J/cm2 can eradicate the bacteria at 60 min and virus at 10 min.No fungus was found on the mask surface at the beginning. Good Fit test , tensile strength and elongation at break were still main maintained after multiple cycles of decontamination. No evidence of physical degradation by gross visual inspection was found. 70% alcohol is also an easy and effective way to eradicate microorganisms on the mask.As the current pandemic is expected to continue for months to years, the need to supply adequate reserves of PPE and develop effective reprocessing is crucial. Our studies demonstrated that the novel silicone mask can be safely reprocessed and decontaminated for many cycles by UVC irradiation and help restore the shortage of the important protective devices in the COVID-19 pandemic era.

详细描述

this study showed that UVC irradiation at the dosage 300 uWatt-sec/cm2 for 1 minute satisfactorily decontaminated the silicone mask as measured by viral culture. The timing to eradicate bacteria was 60 minutes longer due to the tolerability of the bacteria .70% alcohol effectively decontaminate the virus and bacteria deposited on the masks and filters. Good level of fit can be maintained following UVC treatment. The tensile strength of the strap was retained over multiple decontamination cycles using UVC and dry heat upto 60 cycles.Given the efficacy of the disinfection by UVC and 70 % alcohol ,these types of decontamination method could potentially be used for the new type of silicone masks half-piece respirator in the setting of a crisis with inadequate supplies of PPE.

研究设计

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

盲法说明

The participants will be tested for fit test before and after UVC determination of the respirators.The other tests were in vitro and based on the survival of bacteria and virus on the masks together with the tensile strength

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers 18 to 60 years old.

排除标准

  • contraindications to fit test, such as asthma, congestive heart failure, anosmia, and ageusia.

研究组 & 干预措施

Fit test

Experimental

All the participants had to pass the initial fit test.After decontamination with UVC irradiation for 60 minutes.The protocol was conducted in accordance with the protocol from the OSHA respiratory protection standard , including the number, type, and duration of the exercise, and the seal checks in accordance with the manufacturer's instructions[15] 60 minutes, fit testing was conducted using qualitative fit test (Bittrex Solution aerosol)

干预措施: UVC Irradiation (Drug)

Fit test

Experimental

All the participants had to pass the initial fit test.After decontamination with UVC irradiation for 60 minutes.The protocol was conducted in accordance with the protocol from the OSHA respiratory protection standard , including the number, type, and duration of the exercise, and the seal checks in accordance with the manufacturer's instructions[15] 60 minutes, fit testing was conducted using qualitative fit test (Bittrex Solution aerosol)

干预措施: Fit test (Device)

Fit test

Experimental

All the participants had to pass the initial fit test.After decontamination with UVC irradiation for 60 minutes.The protocol was conducted in accordance with the protocol from the OSHA respiratory protection standard , including the number, type, and duration of the exercise, and the seal checks in accordance with the manufacturer's instructions[15] 60 minutes, fit testing was conducted using qualitative fit test (Bittrex Solution aerosol)

干预措施: Tensile strength (Device)

结局指标

主要结局

Fit test

时间窗: 3 days

The percent of participants that passed the fit test after UVC decontamination

Colony count of microorganisms

时间窗: 2 weeks

Colony count of virus ,bacteria and fungus after UVC and alcohol decontamination

Load of Tensile strength

时间窗: 2 weeks

Measure tensile strength and elengation at break after UVC irradiation (Millipascal)

次要结局

未报告次要终点

研究者

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

Thananda Trakarnvanich

Associate Professor

Bangkok Metropolitan Administration Medical College and Vajira Hospital

研究点 (1)

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