Evaluating N95 Respirator Designs: A Mixed-Methods Pilot and Feasibility Study

ABSTRACT (300/300 words)      Background. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has had a global impact, underscoring the importance of personal protective equipment (PPE). The use of N95s reduces the risk of airborne infection; however, in the absence of equitable designs, health care workers (HCWs) who do not fit the average White male head and face are at an increased risk of airborne infectious diseases.?      Objectives. Primary: Feasibility of a mixed-method study, with a sample size of 100, 50% of participants self-identifying as non-White and having at least one characteristic of interest. Secondary: (1) Generate quantitative evidence on N95 fit using a PortaCount fit test, (2) describe participant-reported feelings on fit and breathability, and (3) evaluate the impacts of the pandemic on a HCW’s overall physical and mental well-being. ?      Methods. This was a mixed-method prospective pilot and feasibility study. Quantitative fit was assessed using a TSI PortaCount test and measurements of bizygomatic breadth and Menton-Sellion length. A survey was administered to collect sociodemographic information, HCWs' assessment of N95 fit, comfort, and the impact of PPE-related challenges on well-being.??      Results. This study did not meet feasibility criteria due to the COVID-19 pandemic restrictions; however, we describe key findings that should inform ongoing analyses of the impact of gender and ethnicity on N95 respirator fit. Following a study amendment to increase eligible sites, 37 of the 41 (90.2%) approached HCWs consented to participate. Compared to other HCWs, non-White females had the lowest mean fit factor. Differences in Menton-Sellion length and bizygomatic breadth were observed between males, females, and White and non-White HCWs. Most HCWs reported physical discomfort and/or negative impacts on their psychological well-being due to fit.?      Conclusions. We identified gender and ethnicity as key factors in the fit of N95s. Differences in gender, ethnicity, and anthropometric measures must be considered in future respirator designs.