A Phase I Study of an 'In-house' Developed Prototype Powered Air Purifying Respirator (PAPR) for Use as Personal Protective Equipment (PPE) for Healthcare Workers (Bubble PAPR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- The primary endpoint is that participating staff rate Bubble PAPR to be more comfortable than current PPE.
研究概览
简要总结
This project will produce a low cost, ergonomic, hood integrated PAPR for use initially within the NHS. It will focus on user centred design, engineering optimisation, feasibility testing, certification and intellectual property protection.
This study will evaluate the pre-CE marked Bubble PAPR prototype PPE in the clinical environment and gather usability data from consenting participants (staff).
详细描述
Aim: To develop low cost, ergonomic, personal protective equipment to prevent virus transmission to NHS healthcare workers.
This project aims to address these problems by taking a user centred design approach to develop and manufacture a highly functional Hood Integrated Personal Air Purifying Respirator (HI-PAPR) at a low cost. The design team brings together Manchester University NHS Foundation Trust (MFT) ICU frontline clinical staff, an experienced product design consultancy, Designing Science Limited (DSL) and the technical expertise of the School of Engineering at the University of Manchester (UoM). The project will run through a rapid design and evaluation cycle in simulated and clinical environments to refine the concept to meet regulatory requirements. The final product could be used in primary/secondary care and in the community and will be ready for wide-scale manufacture and supply for the UK NHS within six months of the project start.
This study will evaluate Bubble PAPR in the clinical environment and gather usability data from frontline healthcare staff.
We hypothesise that:
- The Bubble PAPR will meet or exceed the British and European standards for PAPRs.
- That participating staff who subsequently use the PAPR will rate the PPE as:
- More comfortable than current PPE
- Safer than current PPE
- Easier to communicate with colleagues than current PPE
- Easier to communicate with patients than current PPE
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent; bedside clinical staff (medical, nursing, allied healthcare professional) who manage patients with COVID-19 disease during routine clinical duties.
排除标准
- •Refusal to participate; unable to, or unwilling to wear the Bubble PAPR
结局指标
主要结局
The primary endpoint is that participating staff rate Bubble PAPR to be more comfortable than current PPE.
时间窗: 1month
Primary outcome measure is 'Comfort' as defined by Q17 of the questionnaire ("Please indicate how comfortable the Bubble PAPR is") on a 7-point Likert scale bounded by 1 (very uncomfortable) through to 7 (very comfortable).
次要结局
- Staff rate Bubble PAPR as easier to communicate with colleagues than existing PPE(1month)
- Staff rate Bubble PAPR as safer than current PPE(1month)
- Staff rate Bubble PAPR as easier to communicate with patients than existing PPE(1month)