跳至主要内容
临床试验/NCT00756574
NCT00756574已完成不适用

A Randomized Control Trial of Surgical Masks vs N95 Respirators to Prevent Influenza in Health Care Workers

McMaster University1 个研究点 分布在 1 个国家目标入组 447 人开始时间: 2008年10月最近更新:
适应症
干预措施

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

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

Active Comparator

surgical mask

干预措施: Surgical mask (Device)

2. N95 Respirator

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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