A Randomized Control Trial of Surgical Masks vs N95 Respirators to Prevent Influenza in Health Care Workers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 447
- 试验地点
- 1
- 主要终点
- Laboratory-confirmed Influenza Infection
研究概览
简要总结
The goal of this study is to compare the efficacy of the surgical mask to the N95 respirator in protecting nurses from influenza in the hospital setting. The investigators propose a non-inferiority randomized controlled trial whereby nurses are randomized to either a surgical mask or an N95 respirator when caring for patients with febrile respiratory illness during the influenza season. The hypothesis is that the surgical mask offers similar protection against influenza to that of the N95. The specific objective of the study is to assess whether the rates of influenza (laboratory-confirmed by PCR and HAI assay), as well as secondary outcomes (influenza-like illness, work-related absenteeism, physician visits for respiratory illness, and lower respiratory infection), are similar among nurses using a surgical mask compared to those using an N95 respirator.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Nurses who work in emergency departments and medical units
- •Nurses expected to work full time (defined as > 37 hours per week)
排除标准
- •Nurses who were not fit tested
- •Nurses who could not pass a fit test
研究组 & 干预措施
1. Surgical
surgical mask
干预措施: Surgical mask (Device)
2. N95 Respirator
N95 respirator
干预措施: N95 mask (Device)
结局指标
主要结局
Laboratory-confirmed Influenza Infection
时间窗: one year
Laboratory confirmed influenza
次要结局
- Physician Visits for Respiratory Illness(one year)
- Influenza-like Illness(Over entire study period)
- Absenteeism(over study period)
