Limiting Factors for Wearing Personal Protective Equipment (PPE) in a Health Care Environment Evaluated in a Randomised Study: Source of Errors?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Physical measurements: Heart rate at 22°C and 28°C in each suit with 19 participants
研究概览
简要总结
Pandemics and re-emerging diseases put pressure on the health care system to prepare for patient care and sample logistics requiring enhanced personnel protective equipment (PPE) for health care workers. We generated quantifiable data on ergonomics of PPE applicable in a health care setting by defining error rates and physically limiting factors due to PPE-induced restrictions. Nineteen study volunteers tested randomly allocated head- or full body-ventilated PPE suits equipped with powered-air-purifying-respirators and performed four different tests (two laboratory tutorials, a timed test of selective attention and a test investigating reaction time, mobility, speed and physical exercise) during 6 working hours at 22°C on one day and 4 working hours at 28°C on another day. Error rates and physical parameters (fluid loss, body temperature, heart rate) were determined and ergonomic-related parameters were assessed hourly using questionnaires. Depending on the PPE system the most restrictive factors were: reduced dexterity due to multiple glove layers, impaired visibility by flexible face shields and back pain related to the respirator of the fully ventilated suit. Heat stress and liquid loss were perceived as restrictive at a working temperature of 28°C but not 22°C.
详细描述
In this randomized study following good clinical practice guidelines nineteen study volunteers were recruited to wear one of two different types of randomly allocated PPE suits (www.randomizer.at) and to perform four different tests six times at 22°C on one day and four times at 28°C on another day in the local core facility clinical research center.
Study participants Recruiting was based on voluntary registration in response to a public announcement. The study was subjected to the local ethical committee review (No. 23-321 ex 10/11) and all persons gave written informed consent according to the Helsinki Declaration. Key lifestyle and medical parameters were documented for every subject. Exclusion criteria were pregnancy, latex and polyvinyl chloride allergy, claustrophobia, hypotension, history of vein thrombosis, chronic obstructive pulmonary disease, epilepsy, cardiovascular and pulmonary diseases, and infectious diseases. Ten male and nine female volunteers were recruited, aged between 21 and 38 years with body-mass-indices from 17.2 to 32.5.
PPE suits Suit A: TychemR F overall whole-body (DuPont de Nemours and Company, 3M, Austria) suit including socks with a reusable light hood VersafloTM S-655 (3M, Austria) and an external 3M JupiterTM Powered Air Turbo Unit (3M Austria) providing head-only positive pressure.
Suit B: 3MTM JS-series Typ 3 Chemical and Respiratory Protective Suit (CRPS, 3M, Austria) with integrated respirator 3M Jupiter JP-ER-03 Powered Air Purifying Turbo (3M, Austria) fixed as a rucksack generating whole-suit positive pressure.
With both suits, Sempercare surgical gloves (Sempermed, powder-free 150; Semperit, Austria) as the first layer, Ansell Sol-Vex gloves 37-900 (Ansell, Medical GBU, VWR, Austria) as a second layer and white rubber boots were worn. Gloves and boots were sealed to the suit using adhesive tape. Tests I and II were performed in a mock-up glove box providing a third layer of latex gloves.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy, good physical and mental resiliance
排除标准
- •pregnancy, latex and PVC allergy, claustrophobia, hypotension, vein thrombosis, COPD, epilepsy, cardiovascular and pulmonary diseases, and infectious diseases.
结局指标
主要结局
Physical measurements: Heart rate at 22°C and 28°C in each suit with 19 participants
时间窗: up to 2 months
Measurement of concentration (d2 Test) at 22°C and 28°C in each suit with 19 participants.
时间窗: up to 2 months
This test will be analysed by descriptive analysis.
Measurement of error rates at 22°C and 28°C in each suit with 19 participants
时间窗: up to 2 months
For both temperatures repeated measurements and analysis of variances (rmANOVA) to assess effects of working time as a within subject factor and suit (A, B) as a between subject factor on the amount of processed tubes and the amount of wrongly screwed or arranged tubes are performed.
Measurement of individual perception and wellbeing during all test series by individual questionnaires at 22°C and 28°C in each suit with 19 participants.
时间窗: up to 2 months
Questionnaire data are recorded 7 times at 22°C and 5 times at 28°C and analysed with descriptive statistics.
Physical measurements: Fluid loss at 22°C and 28°C in each suit with 19 participants.
时间窗: up to 2 months
Physical measurements: Body temperature at 22°C and 28°C in each suit with 19 participants.
时间窗: up to 2 months
Measurement of reaction time at 22°C and 28°C in each suit with 19 participants.
时间窗: upt o 2 months
This test will be analysed by descriptive analysis.
次要结局
未报告次要终点