A randomised clinical trial to evaluate the safety, fit, comfort of a novel N95 mask in children

Abstract

Children are more vulnerable to the risks of air pollution, including susceptibility to acquiring chronic diseases in their developing lungs. Despite these, there are no specific masks designed for and tested in children that are available to protect our young from the common particulate air pollutants today. We evaluated safety, fit and comfort of a specially designed paediatric N95 mask with an optional micro ventilator (micro fan, MF) in healthy children aged 7–14 years, in a randomized, two-period crossover design. The subjects’ cardiorespiratory physiological measurements were assessed in different states of physical activity under different interventions (mask without and with MF). A total of 106 subjects were recruited between July-August 2016. The use of the mask without MF increased the End-Tidal CO2 (ETCO2) and Fractional concentration of Inspired CO2 (FICO2) at rest and on mild exertion, as expected. The use of the mask with MF brought FICO2 levels comparably closer to baseline levels without the mask for both activities. The mask, with or without the MF, was found to be well fitting, comfortable and safe for use in children at rest and on mild exertion. The N95 mask tested offers a promising start for more studies in the paediatric population.

Health effects of wildfire smoke in children and public health tools: a narrative review

“…While driving, air should be recirculated in the car for an expected decrease of ~80% while the windows are closed [ 146 ]. If a child has to be outdoors, or exposed to outdoor air, their exposure would likely be decreased the most (~80%) [ 100 , 102 , 109 ] by wearing a small size N95 respirator, ideally one that has been designed specifically for children (not yet available, but it they were, these might have reductions up to 95% if worn correctly) [ 108 , 109 ]. These benefits would only be expected for short durations, however, as decreases of that magnitude depend on the respirator being worn correctly with minimal fidgeting.…”

“…In the Dutch paper mentioned above, 11 children (ages 5–11) performed tasks while the particles inside and outside of an adult N95 respirator were measured, and on average only 3–8% of the particles present outside the respirator were present inside [ 100 ]. The first published full evaluation of an N95 respirator designed for children was just published in the late 2019 [ 108 ]. In this paper, Goh et al present data showing that in a sample of 106 healthy, Singaporean children aged 7–14, all were able to achieve adequate mask fit using a quantitative mask fit test.…”

Individual- and Household-Level Interventions to Reduce Air Pollution Exposures and Health Risks: a Review of the Recent Literature

“…The benefits of reduced PM 2.5 concentrations from electrostatic precipitators and negative ion generators may be offset by the harmful effects of ozone and negative ions, respectively [67•, 68]. Respirators designed for occupational use may be unavailable or prohibitively expensive in some settings [69, 126•], a good facemask fit may be unachievable for children and some adults [127][128][129], and a poor fitting facemask may give a false sense of security [38]. Higher efficiency masks, such as N95, can be uncomfortable and may make breathing difficult [77•, 80].…”

“…There is anecdotal evidence that N95 and equivalent masks are often unavailable in the most polluted locations, so we recommend health studies of the face coverings that are available and used in those settings. In addition, while a small number of studies evaluated comfort and "wearability" of facemasks among children [128,129], we are unaware of any studies of the exposure or health benefits of facemask use among children in community settings. The standard advice during pollution episodes is to remain indoors and reduce outdoor activities.…”

Impact of respiratory protective devices on respiration: Implications for panic vulnerability during the COVID-19 pandemic.

“…Thus, SMs may be more tolerable for individuals vulnerable to panic, although further studies on the physiological effects of SMs are needed for confirmation. Furthermore, novel N95 FFRs with micro fans or elastomeric respirators with breathing system filters, might be useful alternatives because these devices are able to better maintain physiological CO 2 levels during use ( Goh et al, 2019 ; Liu et al, 2020 ).…”