Development of a Novel Hood Shield to Enhance PPE Security and Minimize COVID-19 Transmission to Front-line Health Care Workers Performing High-risk Procedures
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Incidence of contamination of any part of the base clothing or exposed skin of the upper body
研究概览
简要总结
This study proposes to compare the effectiveness of two different levels of PPE in protecting front-line health care workers from self-contamination with droplets and aerosolized particles during a simulated endotracheal intubation, an aerosol-generating medical procedure.
详细描述
Hospital acquired infection and death of healthcare workers is an alarming problem during the COVID-19 pandemic. Avoiding transmission of COVID-19 to front-line health care workers in Ontario with optimal Protective Personal Equipment (PPE) is a public health priority to prevent attrition of the health care work force at a time when it is most needed to care for the needs of Ontarians.
Health care workers performing Aerosol Generating Medical Procedures (AGMPs) (e.g. endotracheal intubation, bronchoscopy and tracheostomies) are at particularly high risk of infection. During AGMPs, medical personnel are contaminated with virus-loaded micro-droplets that may be suspended in the air for up to 3 hours.
Use of effective PPE is paramount in protecting health care workers during these high-risk procedures. Limited world-wide supplies of PPE and disruption of supply chains is a current concern. Having local sources of PPE production could help secure supply and protect Ontario's health care work force.
Current standard PPE equipment used during high-risk procedures in Ontario includes a fit-tested N95 mask, an open face shield, a procedure gown and double extended-cuff gloves. This level of PPE leaves certain areas of the head and neck exposed to contamination with viral aerosol and droplets, and could be a source for self-contamination despite meticulous donning and doffing. In fact, extensive contamination of the front surfaces, the neck, forearms, wrists and hands has been previously identified during simulation of medical procedures.
Contamination of the upper body, especially the head and neck, hands and wrists poses the highest risk of potential infection as viral contaminants in these parts of the body are most likely to reach the mucosal surfaces of the mouth, nose and eyes, which are the recognized entry points of viral infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The research coordinator documenting all outcome data will be blinded to the group allocation.
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, ASA 1-2 members of intubating team (staff anesthesiologists, fellows, anesthesia assistants, nurses) at the Toronto Western Hospital, University Health Network.
- •Male or female
排除标准
- •a. Lack of a donning and doffing PPE training session at TWH in the last 6 months.
结局指标
主要结局
Incidence of contamination of any part of the base clothing or exposed skin of the upper body
时间窗: 0-1 hour After doffing is complete
Incidence of contamination of any part of the base clothing or exposed skin of the upper body (head or neck, forearms, arms, wrists, hands or torso)
次要结局
- 2) Number of discrete areas of contamination of <1 cm2 and >1 cm2(0-1 hour After doffing is complete)
- 3) Visibility during the simulated procedure(0-1 hour After doffing is complete)
- 1) Number of body areas contaminated(0-1 hour After doffing is complete)
- 5) Ease of breathing while wearing PPE(0-1 hour After doffing is complete)
- 4) Ease of intubation procedures when wearing PPE(0-1 hour After doffing is complete)
- 6) Thermal comfort while wearing the PPE(0-1 hour After doffing is complete)
- 7) Incidence of breaching of doffing procedures(0-1 hour After doffing is complete)