A Safety Assessment of the iZephyr Hood for Non Invasive Ventilation in COVID-19 Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Determine the background concentration of SARS-Co-V2 around COVID patients receiving NIV
研究概览
简要总结
This study is a safety assessment of the iZephyr hood a novel aerosol removal device in patients receiving non invasive ventilation for COVID-19.
详细描述
Demonstrate that safety and suitability of the iZephyr Hood in patients receiving non-invasive ventilation (NIV) or high flow oxygen therapy (HFOT).
Determine the user acceptability of the iZephyr Hood in patients receiving NIV and HFOT.
Determine the reduction in aerosol spread of COVID-19 viral particles when using the Zephyr hood in patients using non-invasive ventilation or high flow oxygen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult COVID-19 negative patients who are requiring non-invasive ventilation (phase II)
- •Adult COVID-19 positive patients who are requiring non-invasive ventilation (Phase III)
排除标准
- •Patients under the age of 18 years or those lacking capacity
研究组 & 干预措施
With i-zephyr
using the hood
干预措施: iZephyr hood (Device)
Without i-zephyr
Not using the hood
结局指标
主要结局
Determine the background concentration of SARS-Co-V2 around COVID patients receiving NIV
时间窗: 3 month
Air and surface sampling for SARS Co-V2 around COVID patients receiving non invasive ventilation or high flow oxygen therapy.
Impact of iZephyr hood on environmental SARS Co-V2 contamination
时间窗: 12 months
Determine if there is a change in the concentration of SARS-Co-V2 virus on the surfaces and in the air samples surrounding a COVID-19 positive patient whilst using the iZephyr compared to when not using the iZephyr.
Determine the background concentration of SARS-Co-V2 when the iZephyr hood is in use
时间窗: 12 months
Air and surface sampling for SARS Co-V2 around COVID patients receiving non invasive ventilation or high flow oxygen therapy inside an iZephyr hood.
次要结局
未报告次要终点