Craniofacial Dimensions as Determinants of the Fitted Performance of Common Face Masks (FACEFIT 2.0)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Cranial Morphology- Self Evaluation
研究概览
简要总结
This study examines the role of craniofacial dimensions and self-evaluation thereof in the protection afforded by masks commonly worn by the public as protection against aerosol contaminants. The effectiveness of instructions for self-evaluation of craniofacial dimensions will be tested against standard digital and manual craniometric methods. Approximately 500 (18+ year old) subjects.
There will be two groups to complete this study (Group A and B). After consenting to participate in the study, subjects in Group A will use a short self-assessment questionnaire to measure their craniofacial dimensions, fill out a questionnaire, and have their face measured using standard anthropological techniques and a 3D camera. They will then enter a chamber containing an atmosphere of aerosolized salt particles where the fitted filtering efficiency of 2 types of face masks will be measured briefly. Subjects in Group B will only complete the craniometric assessment, self-assessment, and questionnaire.
Participation time is approximately 60 minutes for Group A and 15 minutes for Group B.
详细描述
Wearing a face mask is a primary protection strategy against airborne infectious agents as well as toxic aerosols such as wildfire smoke. Despite the ubiquitous presence of masks in public life in recent years, the average person has a poor understanding of factors that influence the fitted performance of the face coverings that they wear. This problem is exacerbated by the lack of mask fit testing available to the public outside of occupational settings subject to regulation. As a result, the vast majority of the population currently wears masks with limited knowledge of their efficacy or the means to acquire it. A simple, validated method to quantitatively self-assess individual craniofacial dimensions relative to that of the general population will permit members of the public to make informed decisions about the types of mask that they wear in specific risk situations, and whether to use fit enhancements to optimize their fitted performance. In addition to limiting the morbidity associated with exposure to poor air quality, an individualized improvement in the efficacy of mask will have a multiplicative effect in the prevention of the transmission of infectious vectors.
Assignment to study groups will be done to ensure equal variation in craniofacial dimensions is equally represented in Group A. This will ensure that data on the relationship between craniofacial morphology and mask efficiency has an approximately equal samples of those with small to large faces.
Group A: Healthy, adult subjects will be recruited and screened for eligibility for the study (See inclusion and exclusion criteria)(See Recruitment section). After giving informed consent, all subjects will complete a craniometric self-assessment form. Next, cranial and facial measurements will be collected using standard anthropological techniques and 3D imaging. Subjects will then participate in a modified version of the quantitative OSHA mask fit testing. Two disposable masks, surgical/procedure and KN95, will be tested both unmodified and modified with a clip. Participants will also complete a short questionnaire.
Group B: Healthy, adult subjects will be recruited and screened for eligibility for the study (See inclusion and exclusion criteria)(See Recruitment section). After giving informed consent, all subjects will complete a craniometric assessment using standard anthropological techniques and 3D imaging. Participants will also complete a short questionnaire.
Recruitment: Subjects will be recruited from the U.S. Environmental Protection Agency Research Triangle Park Campus. Participants will be recruited in person at the cafeteria and during large gatherings (see in-person script and flyer).
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
- Basic Science
- 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
- 未提供
排除标准
- •Not feeling well.
- •Unable to walk unassisted, stand or sit still for 15 minutes at a time.
- •Suffered a heart attack, cardiac arrest or stroke in the past 6 months.
- •Have been hospitalized overnight or sought urgent medical care in the last 30 days.
- •Have an unspecified illness, which in the judgment of the medical staff, might increase the risk associated with this study will be a basis for exclusion.
- •Pregnant, attempting to become pregnant or breastfeeding.
- •BMI (kg/m2) of ≤16.0 or ≥ 50.0
- •Have a facial hair style that will interfere with the facemask seal.
- •Not feeling well.
- •Unable to sit still for 5 minutes
结局指标
主要结局
Cranial Morphology- Self Evaluation
时间窗: The self-evaluation will take approximately ten minutes and be filled out once during the study visit (Day 1).
Cranial morphology will be assessed using a self-evaluation that guides participants on how to measure five dimensions of their head/face including: nose length, nose arc, face width, neck circumference, and ear breadth. Participants will record their measurement for each cranial/facial features using the instructions provided on the self-evaluation form. Investigators will then use the five recorded values to cluster each participant into one of four categories of overall face and head shape/size.
Fitted Filtration Efficiency
时间窗: During fitting procedure (90 seconds for each condition)
A mask fit procedure will be performed based on an OSHA (Occupational Safety and Health Administration)- approved protocol during the baseline visit. The efficiency of masks will be determined by a percentage of particle number measured behind the facemask over the particle number in the ambient air. Mask fit efficiency values from different levels of mask fit instructions will be compared.
次要结局
- Cranial Morphology- Caliper Measurement(The craniometric assessment will take approximately 5 minutes and be completed before the fit testing procedure.)
- Cranial Morphology- 3D Imaging(The 3D imaging will take approximately 5 minutes and be completed before the fit testing procedure.)
- FaceFit 2.0 Face Filtering PIece Usage Survey(This survey will take about five minutes and be completed before the mask fit testing.)