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Study for Testing and Reviewing Improvised PPE Effectiveness 3 (STRIPE-3) (STRIPE-3)

2020年6月4日 更新者:Guy's and St Thomas' NHS Foundation Trust

Study for Testing and Reviewing Improvised PPE Effectiveness 3 (STRIPE-3) - a Third Comparative Trial Assessing the Safety of Improvised PPE

Personal protective equipment (PPE) is vital to ensuring staff safety during the COVID-19 pandemic. Properly designed, formal PPE (fPPE) is in increasingly short supply, and a series of improvised PPE (iPPE) designs have been widely circulated on the internet, particularly on social media. Groups have started to publicise these devices through websites and the lay press. Some are even using crowd-funding to finance the purchase of these systems with the intention of supplying NHS workers in place of approved systems.

It is not clear what degree of testing these systems have undergone. The investigators are already planning trials formally investigating the quality of seal offered by these improvised systems. Currently the team are investigating a designed based on a modified snorkel mask (STRIPE-1). In the current study the investigators wish to extend this investigation to consider the atmosphere within the mask.

This is an important question, as modifications to the snorkel design have changed the way gases mix within the system. This might increase the risk that the user will rebreathe expired gases, which will dilute the amount of oxygen available to them, and increase the carbon dioxide levels to which they are exposed. At extreme deviations, these might pose a potential health hazard over and above the risks posed by COVID-19 exposure via a poor mask seal.

This study will therefore recruit a convenience sample of 10, and request they wear two masks sequentially. These masks will comprise: a formally designed and tested commercial FFP3 mask, and one design of improvised PPE, based on the snorkel design available on the internet.

Each mask will be worn for a total of 40 minutes. In the first 20 minutes measurements will be taken with the user at rest. In the second 20 minutes measurements will be taken while the user undertakes light exercise.

研究概览

研究类型

观察性的

注册 (实际的)

10

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • London、英国、SE1 7EH
        • St Thomas' Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Recruits will be drawn from amongst staff at Guy's and St Thomas' NHS Foundation Trust (London, UK) who are required to be fit-tested on tight-fitting FFP3 masks as part of their normal clinical duties.

描述

Inclusion Criteria:

  • Willing and able to give informed consent for participation in the study
  • Healthy adults, male or female, aged 18 or more
  • Clean-shaven at the point of testing
  • Willing and able to undertake 20 minutes of light exercise e.g. stepping

Exclusion Criteria:

  • They have facial hair that would disrupt the seals of the mask
  • They have significant facial injuries or malformations that preclude a good mask seal

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:案例交叉
  • 时间观点:预期

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Oxygen concentration while wearing purpose-designed mask
大体时间:40 minutes starting from intervention (donning of mask)
5-minute measurement of oxygen concentration in inspired and expired gases
40 minutes starting from intervention (donning of mask)
Oxygen concentration while wearing improvised snorkel-based mask
大体时间:40 minutes starting from intervention (donning of mask)
5-minute measurement of oxygen concentration in inspired and expired gases
40 minutes starting from intervention (donning of mask)

次要结果测量

结果测量
措施说明
大体时间
Carbon dioxide concentration while wearing purpose-designed mask
大体时间:40 minutes starting from intervention (donning of mask)
5 minute measurement of carbon dioxide concentration in inspired and expired gases
40 minutes starting from intervention (donning of mask)
Carbon dioxide concentration while wearing improvised snorkel-based mask
大体时间:40 minutes starting from intervention (donning of mask)
5 minute measurement of carbon dioxide concentration in inspired and expired gases
40 minutes starting from intervention (donning of mask)
Heart rate while wearing purpose-designed mask
大体时间:40 minutes starting from intervention (donning of mask)
5 minute measurement of heart rate
40 minutes starting from intervention (donning of mask)
Heart rate while wearing improvised snorkel-based mask
大体时间:40 minutes starting from intervention (donning of mask)
5 minute measurement of heart rate
40 minutes starting from intervention (donning of mask)
Respiratory rate while wearing purpose-designed mask
大体时间:40 minutes starting from intervention (donning of mask)
5 minute measurement of respiratory rate
40 minutes starting from intervention (donning of mask)
Respiratory rate while wearing improvised snorkel-based mask
大体时间:40 minutes starting from intervention (donning of mask)
5 minute measurement of respiratory rate
40 minutes starting from intervention (donning of mask)
Oxygen saturation while wearing purpose-designed mask
大体时间:40 minutes starting from intervention (donning of mask)
5 minute measurement of oxygen saturation
40 minutes starting from intervention (donning of mask)
Oxygen saturation while wearing improvised snorkel-based mask
大体时间:40 minutes starting from intervention (donning of mask)
5 minute measurement of oxygen saturation
40 minutes starting from intervention (donning of mask)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Paul R Greig, MBChB、Guy's and St Thomas' NHS Foundation Trust

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年5月1日

初级完成 (实际的)

2020年6月5日

研究完成 (实际的)

2020年6月5日

研究注册日期

首次提交

2020年4月21日

首先提交符合 QC 标准的

2020年4月23日

首次发布 (实际的)

2020年4月24日

研究记录更新

最后更新发布 (实际的)

2020年6月9日

上次提交的符合 QC 标准的更新

2020年6月4日

最后验证

2020年4月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • TAP_PRG_21_04_2020_2

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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