Baldachin-Study: Ceiling HEPA-filtration to Prevent Nosocomial Transmission of COVID-19 in Open-space Multiple Bed Patient Areas
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Proportion of nosocomially infected individuals within 4 days after exposure
研究概览
简要总结
In this study, a patient space occupied by a patient with confirmed COVID-19 in an open-space multiple bed area in the Intermediate Care Unit will be equipped with a mobile, optimally placed high efficiency particulate air ("HEPA")-equivalent air filtration unit ("Baldachin") in addition to existing hospital policy infection prevention and control measures. The investigators are going to evaluate this intervention regarding its capacity to prevent the nosocomial onwards transmission of Sars-COV2 to patients located in the same multiple-bed open space patient area.
详细描述
SARS-CoV-2 transmission includes a considerable amount of long-distance aerosol transmission. Ideal isolation is in single rooms. Isolation in special care multiple bed open-space patient areas (e.g. in the Intensive and Intermediate Care Unit) is set back to onsite isolation with distancing and ventilation as partial mitigation measures against nosocomial transmission.
The investigators want to assess the effect of supplementation of existing room ventilation by means of an optimally placed mobile high efficiency particulate air ("HEPA") filtration unit ("Baldachin") in the ceiling area over confirmed COVID-19 infected patients on nosocomial onwards transmission to patients located in the same open-space multiple bed area. In order to quantify the effect, the investigators will determine the proportion of nosocomially infected individuals as assessed by nasopharyngeal swab on day 4 after the last exposure amongst all in the same room exposed patients in cardiovascular open-space Intermediate Care Unit rooms with "Baldachin" vs. open-space Intermediate Care Unit rooms without "Baldachin".
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult inpatients of included open-space IMC units with lab-confirmed SARS-CoV-2 infection, symptom onset or date of test ≤10 days prior inclusion.
排除标准
- •Pregnancy, unability to give consent (e.g. informed consent form not available in patient language or non-judicious)
结局指标
主要结局
Proportion of nosocomially infected individuals within 4 days after exposure
时间窗: 4 days after last exposure
Assessed by nasopharyngeal swab on day 4 after the last exposure amongst all in the same room exposed patients in cardiovascular open-space Intermediate Care Unit ("IMC") rooms with the environmental interventions vs. open-space IMC rooms without the environmental intervention
次要结局
- Proportion of immunocompromised patients among those exposed(At the time of exposure)
- Proportion of nosocomially infected patients within 10 days after exposure(10 days after last exposure)
- Age of exposed patients(At the time of exposure)
- Gender of exposed patients(At the time of exposure)
- Exposure duration(Period when exposed to a patient with confirmed COVID-19 in the same room)
- Preexisting air change rate per hour in the rooms where exposure occurs(At the time of exposure)