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临床试验/NCT05942534
NCT05942534已完成不适用

Pediatric Mask Fit Study: Comparing the Performance of Cloth Masks, Procedure Masks With and Without Modifications and Respirators in Children

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2023年7月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
1
主要终点
Fitter filtration efficiency and fit factor

研究概览

简要总结

This study will evaluate the performance of various face masks and respirators on children by examining their fitted filtration efficiency (FFE) and mask fit. It will also evaluate the impact of different types of mask modifications (for example, twisting the ear loops, tuck and tie) on FFE and mask fit, with the goal of determining how to optimize mask performance in children. It will also provide information on mask and respirator comfort and acceptability. This data will help inform public health messaging around mask choice for children and also modifications that can be made to improve fit for children who may not have access to various mask types.

详细描述

This will be a prospective cross-sectional study of 200 children aged 4 to 17 years. Participants will be assigned to either the mask type assessment (Objective 1) or the mask modification assessment (Objective 2) and have a date and time scheduled for testing.

The mask type assessment will compare the FFE and fit factor of a cloth mask, child and adult medical mask, child and adult KN95 respirator, and N95 respirator. The mask modification assessment will compare the FFE and fit factor of a child medical mask, adult medical mask with and without modifications (tuck and tie, twisted ear loops), and child and adult N95 respirator. Quantitative fit testing will be conducted using a TSI Portacount Pro Respirator Fit Tester model 8038+. Testing will be performed in an identified designated area at the hospital or in the community (i.e., schools or community center), monitored for ventilation, temperature and humidity. We will also measure the ambient particles to ensure adequate particle count. The participants will be asked to evaluate the mask, respirator or modification based on a variety of criteria including comfort, breathability and acceptability. This will be completed immediately after the fit assessment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
4 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Aged 4-17
  • able to tolerate wearing a mask

排除标准

  • Children will be excluded if they have contraindications to wearing a mask.

结局指标

主要结局

Fitter filtration efficiency and fit factor

时间窗: First visit (1 hour)

To compare the performance of different mask (cloth and medical) and respirator (KN95 and N95) types and mask modifications in children, as measured by fitted filtration efficiency (FFE) and fit factor.

次要结局

  • Mask and respirator comfort and acceptability(First visit (1 hour))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michelle Science

Staff Physician

The Hospital for Sick Children

研究点 (1)

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