Eficacia de la mascarilla facial con filtro de partículas N95 y de la mascarilla quirúrgica durante la respiración humana: dos vías para la penetración de partículas.

RESUMENEl nivel de protección ofrecido por las mascarillas con filtro de partículas y las mascarillas se establece considerando el porcentaje de partículas ambientales que penetran dentro del dispositivo de protección. Existen dos vías de penetración: (1) la infiltración a través del sellado facial de la mascarilla y (2) a través del medio filtrante. El objetivo principal de este estudio fue diferenciar el aporte proveniente de cada una de estas dos vías para partículas cuyo tamaño oscila entre 0.03-1 µm en condiciones de respiración reales. Así, mientras se realizaban pruebas de ajuste convencionales, se evaluaron una mascarilla respiratoria autofiltrante N95 y una mascarilla quirúrgica usada comúnmente en entornos de atención médica en 25 sujetos (número coincidente con el último panel de pruebas de ajuste del Instituto Nacional de Seguridad y Salud Laborales). Asimismo, ambas mascarillas fueron evaluadas empleando maniquíes de respiración que imitaban de forma precisa los patrones de respiración registrados previamente en los sujetos evaluados. Posteriormente, se compararon los datos de penetración obtenidos en las evaluaciones realizadas con sujetos humanos y con maniquíes para determinar los diferentes tamaños de partículas, así como los patrones de respiración. Así se determinaron 5,250 valores de penetración específicos correspondientes al ejercicio y el tamaño de las partículas. Para cada valor se calcularon la tasa de infiltración a través del sellado facial de la mascarilla y la tasa de infiltración a través del filtro, con la finalidad de cuantificar los aportes relativos realizados por cada vía de penetración. El número de partículas que penetra mediante infiltración del sellado facial de la mascarilla autofiltrante/mascarilla quirúrgica probadas excedió ampliamente el número de aquellas que lo hacen a través del filtro. Para la mascarilla autofiltrante N95, el exceso fue (en promedio) de un orden de magnitud y se incrementó notablemente al aumentar el tamaño de las partículas (p < 0.001): ∼7 veces mayor para 0,04 µm, ∼10 veces para 0.1 µm y ∼20 veces para 1 µm. En el caso de la mascarilla quirúrgica, la tasa de infiltración a través del sellado facial de la misma con respecto al filtro osciló entre 4.8 y 5.8 y no se vio significativamente afectada por el tamaño de las partículas para la fracción del submicrómetro evaluado. El movimiento facial/corporal tuvo un efecto pronunciado en el aporte relativo de las dos vías de penetración. La intensidad de la respiración y las dimensiones faciales mostraron alguna influencia (aunque limitada). Considerando que la mayoría de las partículas que penetraron ingresaron a través del sellado facial, al desarrollar la mascarilla autofiltrante/mascarilla quirúrgica la prioridad debería ser realizar una adecuación que permitiera eliminar o minimizar la infiltración a través del sellado facial y no mejorar la eficiencia del medio de filtro.

Respiratory follow-up pre- and post-engineering controls or cessation of added diacetyl at four microwave popcorn facilities.

In a 7-year study at 4 microwave popcorn facilities, mixing room employees exposed to diacetyl prior to the introduction of respirators showed significant loss of lung function but did not continue to decline longitudinally faster than other job categories http://bit.ly/2xwWRiw.

Performance of an improperly sized and stretched-out loose-fitting powered air-purifying respirator: Manikin-based study.

The objective of this study was to investigate the protection level offered by a Powered Air-Purifying Respirator (PAPR) equipped with an improperly sized or stretched-out loose-fitting facepiece using constant and cyclic flow conditions. Improperly sized PAPR facepieces of two models as well as a stretched-out facepiece were tested. These facepieces were examined in two versions: with and without exhaust holes. Loose-fitting facepieces (size "large") were donned on a small manikin headform and challenged with sodium chloride (NaCl) aerosol particles in an exposure chamber. Four cyclic flows with mean inspiratory flows (MIFs) of 30, 55, 85, and 135 L/min were applied using an electromechanical Breathing Recording and Simulation System (BRSS). The manikin Fit Factor (mFF) was determined as the ratio of aerosol concentrations outside (Cout) to inside (Cin) of the facepiece, measured with a P-Trak condensation particle counter (CPC). Results showed that the mFF decreased exponentially with increasing MIF. The mFF values of the stretched-out facepiece were significantly lower than those obtained for the undamaged ones. Facepiece type and MIF were found to significantly affect the performance of the loose-fitting PAPR. The effect of the exhaust holes was less pronounced and depended on the facepiece type. It was concluded that an improperly sized facepiece might potentially offer relatively low protection (mFF < 250) at high to strenuous workloads. The testing was also performed at a constant inhalation flow to explore the mechanism of the particle-facepiece interaction. Results obtained with cyclic flow pattern were consistent with the data generated when testing the loose-fitting PAPR under constant flow conditions. The time-weighted average values of mFF calculated from the measurements conducted under the constant flow regime were capable of predicting the protection under cyclic flow regime. The findings suggest that program administrators need to equip employees with properly sized facepieces and remove stretched-out ones from workplace. Manufacturers should emphasize the importance of proper sizing with their user instructions.

Respiratory Protection for Oxygen Deficient Atmospheres.

This article describes several aspects of oxygen (O2) deficiency with an emphasis on respirator programs and respirator selection. The Occupational Safety and Health Administration's (OSHA) 29 CFR 1910.134 and ANSI/ASSE Z88.2-2015 (Z88.2) have much in common. However, their exposure criteria and terminology used for describing levels of O2-deficiency and the approaches to assessing O2-deficiency differ. These differences can have a significant impact on an employer's respirator program and respirator selections for workplaces at altitudes above sea level. Under certain circumstances, Z88.2 leads to a more conservative respirator selection than OSHA because its O2-deficiency criteria and hazard assessment approach relies directly on partial pressure of oxygen (PO2) at all altitudes. Z88.2 defines an O2-deficient atmosphere as either immediately dangerous to life or health (IDLH), or non-IDLH based on the atmosphere's PO2 and defines respirator selection for these two O2-deficient atmospheres. Unlike Z88.2, OSHA does not directly access the biologically significant aspect of an atmosphere's PO2 in its hazard assessment. OSHA defines an O2-deficient atmosphere based upon a percentage of oxygen. OSHA does not use the term "O2-deficient IDLH"; however, OSHA considers any atmosphere with less than 19.5% O2 as IDLH and defines respirator selection for IDLH atmospheres. Although OSHA does not use the term "PO2" in their respirator standard, OSHA's exceptions to O2-deficient IDLH respirator selection policy are based on PO2 altitude-adjusted, O2 percentage criteria. This article provides descriptions of OSHA and Z88.2 requirements to evaluate workplace oxygen deficiency, their approaches to O2-deficiency hazard assessment, and describes their significance on respirator programs and selections. Alternative solutions to wearing respirators for protection against O2-deficiency resulting solely from high altitudes are also discussed. Selection and implementation of alternative solutions by the employer and their Physician or other Licensed Health Care Professional (PLHCP) are not covered by either respirator standard. Appendix A provides information about the physiological effect of wearing respirators and the mechanics of respiration, which is an important consideration in lower O2 atmospheres.

HRCT/CT and associated spirometric effects of low Libby amphibole asbestos exposure.

OBJECTIVE: Evaluate the relationship between cumulative fiber exposure and high-resolution or conventional chest computed tomography (HRCT/CT) changes and spirometry of workers with Libby amphibole asbestos exposure. METHODS: Of the original 1980 cohort (n = 513), 431 were living and asked to participate. Images were evaluated for localized pleural thickening (LPT), diffuse pleural thickening (DPT), and parenchymal changes. RESULTS: A total of 306 participants provided either HRCT/CT scans (n = 191) or chest radiographs (n = 115). Of the 191 with HRCT/CT, 52.9% had pleural changes and 13.1% had parenchymal changes. Those with LPT only, LPT and/or DPT, or DPT and/or parenchymal changes had mean 6.1, 8.0, and 18.0 loss in percent predicted forced vital capacity, respectively. CONCLUSIONS: Exposure to vermiculite containing amphibole fibers is associated with pleural and parenchymal HRCT/CT changes at low cumulative fiber exposure; these changes are associated with spirometric decrements.

Manikin-based performance evaluation of elastomeric respirators against combustion particles.

This study investigated the effects of faceseal leakage, breathing flow, and combustion material on the overall (non-size-selective) penetration of combustion particles into P-100 half and full facepiece elastomeric respirators used by firefighters. Respirators were tested on a breathing manikin exposed to aerosols produced by combustion of three materials (wood, paper, and plastic) in a room-size exposure chamber. Testing was performed using a single constant flow (inspiratory flow rate = 30 L/min) and three cyclic flows (mean inspiratory flow rates = 30, 85, and 135 L/min). Four sealing conditions (unsealed, nose-only sealed, nose and chin sealed, and fully sealed) were examined to evaluate the respirator faceseal leakage. Total aerosol concentration was measured inside (C(in)) and outside (C(out)) the respirator using a condensation particle counter. The total penetration through the respirator was determined as a ratio of the two (P = C(in) / C(out)). Faceseal leakage, breathing flow type and rate, and combustion material were all significant factors affecting the performance of the half mask and full facepiece respirators. The efficiency of P-100 respirator filters met the NIOSH certification criteria (penetration ≤0.03%); it was not significantly influenced by the challenge aerosol and flow type, which supports the current NIOSH testing procedure using a single challenge aerosol and a constant airflow. However, contrary to the NIOSH total inward leakage (TIL) test protocol assuming that the result is independent on the type of the tested aerosol, this study revealed that the challenge aerosol significantly affects the particle penetration through unsealed and partially sealed half mask respirators. Increasing leak size increased total particle penetration. The findings point to some limitations of the existing TIL test in predicting protection levels offered by half mask elastomeric respirators.

Effect of Particle Size on the Performance of an N95 Filtering Facepiece Respirator and a Surgical Mask at Various Breathing Conditions.

The effect of aerosol particle size on the performance of an N95 filtering facepiece respirator (FFR) and a surgical mask (SM) was evaluated under different breathing conditions, including breathing frequency and mean inspiratory flow (MIF) rate. The FFR and SM were sealed on a manikin headform and challenged with charge-equilibrated NaCl aerosol. Filter penetration (Pfilter) was determined as the ratio of aerosol concentrations inside and outside the FFR/SM size-selectively (28 channels) within a range of 20 to 500 nm. In addition, the same models of the FFR and SM were donned, but not sealed, on an advanced manikin headform covered with skin-like material. Total inward leakage (TIL), which represents the total particle penetration, was measured under conditions identical to the filter penetration experiment. Testing was conducted at four mean MIFs (15, 30, 55 and 85 L/min) combined with five breathing frequencies (10, 15, 20, 25 and 30 breaths/min). The results show that SM produced much higher Pfilter and TIL values, and thus provide little protection against aerosols in the size range tested. Pfilter was significantly affected by particle size and breathing flow rate (p <0.05) for the tested FFR and SM. Surprisingly, for both devices, Pfilter as a function of the particle size exhibited more than one peak under all tested breathing conditions. The effect of breathing frequency on Pfilter was generally less pronounced, especially for lower MIFs. For the FFR and SM, TIL increased with increasing particle size up to about 50 nm; for particles above 50 nm, the total penetration was not significantly affected by particle size and breathing frequency; however, the effect of MIF remained significant.

Unraveling the relationship between aeroallergen sensitization, gender, second-hand smoke exposure, and impaired lung function.

BACKGROUND: Contradictory findings on the differential effects of second-hand smoke (SHS) on lung function in girls and boys may result from masked relationships between host and environmental factors. Allergic sensitization may augment the relationship between SHS and decreased lung function, although its role in relation to the inconsistent gender differences in children has not been elucidated. HYPOTHESIS: We hypothesize that there will be differences between boys and girls related to early-life allergic sensitization and exposure to SHS on pulmonary function later in childhood. METHODS: Participants in this study (n = 486) were drawn from the Cincinnati Childhood Allergy and Air Pollution (CCAAPS) birth cohort study consisting of 46% girls. Allergic sensitization was assessed by skin prick test (SPT) to 15 aeroallergens at ages 2, 4, and 7, while pulmonary function and asthma diagnosis occurred at age 7. SHS exposure was measured by hair cotinine at ages 2 and/or 4. Gender differences of SHS exposure on pulmonary function among children with positive SPTs at ages 2, 4, and 7 as well as first- and higher-order interactions were examined by multiple linear regression. Interactions significant in the multivariate models were also examined via stratification. Comparisons within and between stratified groups were assessed by examining the slope of the parameter estimates/beta coefficients and associated p-values and confidence intervals. RESULTS: Increased cotinine levels were significantly associated with decreases in FEV(1) (-0.03 l, p < 0.05), peak expiratory flow (-0.07 l/s, p < 0.05), and FEF (25-75%) (-0.06 l/s, p < 0.01). The interaction between cotinine and sensitization at age 2 was borderline significant (p = 0.10) in the FEF(25-75%) model and showed an exposure response effect according to the number of positive SPTs at age 2; zero (-0.06 l/s, p < 0.01), one (-0.09 l/s, p < 0.05), or two or more positive SPTs (-0.30 l/s, p < 0.01). Despite increased polysensitization among boys, the association between cotinine and FEF(25-75%) among girls, with two or more positive SPTs at age 2, showed the greatest deficits in FEF(25-75%) (-0.34 l/s vs. -0.05 l/s and -0.06 l/s for non-sensitized girls and boys, respectively. Girls with two or more positive SPTs showed a twofold greater decrease in FEF(25-5%) (-0.34 l/s; 95% CI: -0.55, -0.13) compared to boys with the same degree of allergic sensitization (-0.18 l/s; 95% CI: -0.41, 0.06), although this difference was not statistically significant. CONCLUSIONS: Reductions in lung function were observed among children exposed to SHS, and the number of aeroallergen-positive SPTs at age 2 modifies this relationship. Girls experiencing early childhood allergic sensitization and high SHS exposure are at greater risk of decreased lung function later in childhood compared to non-sensitized girls and boys and demonstrate greater deficits compared to boys with similar degrees of sensitization.

Efficacy and safety of sirolimus in lymphangioleiomyomatosis.

BACKGROUND: Lymphangioleiomyomatosis (LAM) is a progressive, cystic lung disease in women; it is associated with inappropriate activation of mammalian target of rapamycin (mTOR) signaling, which regulates cellular growth and lymphangiogenesis. Sirolimus (also called rapamycin) inhibits mTOR and has shown promise in phase 1-2 trials involving patients with LAM. METHODS: We conducted a two-stage trial of sirolimus involving 89 patients with LAM who had moderate lung impairment--a 12-month randomized, double-blind comparison of sirolimus with placebo, followed by a 12-month observation period. The primary end point was the difference between the groups in the rate of change (slope) in forced expiratory volume in 1 second (FEV(1)). RESULTS: During the treatment period, the FEV(1) slope was -12±2 ml per month in the placebo group (43 patients) and 1±2 ml per month in the sirolimus group (46 patients) (P<0.001). The absolute between-group difference in the mean change in FEV(1) during the treatment period was 153 ml, or approximately 11% of the mean FEV(1) at enrollment. As compared with the placebo group, the sirolimus group had improvement from baseline to 12 months in measures of forced vital capacity, functional residual capacity, serum vascular endothelial growth factor D (VEGF-D), and quality of life and functional performance. There was no significant between-group difference in this interval in the change in 6-minute walk distance or diffusing capacity of the lung for carbon monoxide. After discontinuation of sirolimus, the decline in lung function resumed in the sirolimus group and paralleled that in the placebo group. Adverse events were more common with sirolimus, but the frequency of serious adverse events did not differ significantly between the groups. CONCLUSIONS: In patients with LAM, sirolimus stabilized lung function, reduced serum VEGF-D levels, and was associated with a reduction in symptoms and improvement in quality of life. Therapy with sirolimus may be useful in selected patients with LAM. (Funded by the National Institutes of Health and others; MILES ClinicalTrials.gov number, NCT00414648.).

A long term study of pulmonary function among US refractory ceramic fibre workers.

BACKGROUND: Cross-sectional studies have shown declines in lung function among refractory ceramic fibre (RCF) workers with increasing fibre exposure. This study followed current and former workers (n=1396) for up to 17 years and collected 5243 pulmonary function tests. METHODS: Cumulative fibre exposure and production years were categorised into exposure levels at five manufacturing locations. Conventional longitudinal models did not adequately partition age-related changes from other time-dependent variables. Therefore, a restricted cubic spline model was developed to account for the non-linear decline with age. RESULTS: Cumulative fibre >60 fibre-months/cc showed a significant loss in lung function at the first test. When results were examined longitudinally, cumulative exposure was confounded with age as workers with the highest cumulative exposure were generally older. A longitudinal model adjusted by age groups was implemented to control for this confounding. No consistent longitudinal loss in lung function was observed with RCF exposure. Smoking, initial weight and weight increase were significant factors. CONCLUSION: No consistent decline was observed longitudinally with exposure to RCF, although cross-sectional and longitudinal findings were discordant. Confounding and accelerated lung function declines with ageing and the correlation of multiple time-dependent variables should be considered in order to minimise error and maximise precision. An innovative statistical methodology for these types of data is described.

Redefining spirometry hesitating start criteria based on the ratio of extrapolated volume to timed FEVs.

BACKGROUND: The primary purpose of this study was to investigate alternative hesitating start criteria for spirometry maneuvers that do not achieve an acceptable plateau. The current hesitating start criterion that has been in use for 30 years is based on clinical opinion from expert users; it was not established based on information from peer-reviewed scientific studies. METHODS: A total of 1,719 workers met the eligibility criteria for this study and contributed 24,945 trials. The fitted lines obtained from linear regressions of each dependent variable, volume of air calculated at time zero using the back extrapolation method (extrapolated volume [EV])/FEV(1), EV/FEV in 3 s (FEV(3)), and EV/FEV in 6 s (FEV(6)) on EV/FVC were determined. The 95th percentile of the prediction interval of each dependent variable corresponding to EV/FVC = 5% was calculated. RESULTS: The values for EV/FEV(1), EV/FEV(3), and EV/FEV(6) corresponding to the 5% EV/FVC value were determined to be 6.62%, 5.59%, and 5.25%, respectively. CONCLUSIONS: A new hesitating start criterion using EV/FEV(6) of 5.25% is recommended for tracings that do not achieve a plateau or when an FEV(6) is performed. An EV/FEV(3) of 5.59% could be incorporated into spirometry software as an early warning signal that could help operators identify trials with potential hesitating starts.

Performance of an N95 filtering facepiece particulate respirator and a surgical mask during human breathing: two pathways for particle penetration.

The protection level offered by filtering facepiece particulate respirators and face masks is defined by the percentage of ambient particles penetrating inside the protection device. There are two penetration pathways: (1) through the faceseal leakage, and the (2) filter medium. This study aimed at differentiating the contributions of these two pathways for particles in the size range of 0.03-1 microm under actual breathing conditions. One N95 filtering facepiece respirator and one surgical mask commonly used in health care environments were tested on 25 subjects (matching the latest National Institute for Occupational Safety and Health fit testing panel) as the subjects performed conventional fit test exercises. The respirator and the mask were also tested with breathing manikins that precisely mimicked the prerecorded breathing patterns of the tested subjects. The penetration data obtained in the human subject- and manikin-based tests were compared for different particle sizes and breathing patterns. Overall, 5250 particle size- and exercise-specific penetration values were determined. For each value, the faceseal leakage-to-filter ratio was calculated to quantify the relative contributions of the two penetration pathways. The number of particles penetrating through the faceseal leakage of the tested respirator/mask far exceeded the number of those penetrating through the filter medium. For the N95 respirator, the excess was (on average) by an order of magnitude and significantly increased with an increase in particle size (p < 0.001): approximately 7-fold greater for 0.04 microm, approximately 10-fold for 0.1 microm, and approximately 20-fold for 1 microm. For the surgical mask, the faceseal leakage-to-filter ratio ranged from 4.8 to 5.8 and was not significantly affected by the particle size for the tested submicrometer fraction. Facial/body movement had a pronounced effect on the relative contribution of the two penetration pathways. Breathing intensity and facial dimensions showed some (although limited) influence. Because most of the penetrated particles entered through the faceseal, the priority in respirator/mask development should be shifted from improving the efficiency of the filter medium to establishing a better fit that would eliminate or minimize faceseal leakage.

An evaluation of irritant smoke to detect exhalation valve leakage in respirators.

This study evaluated the ability of a qualitative fit-test method (irritant smoke) to detect known exhalation valve leakage. The OSHA protocol for the irritant smoke test mandates the use of a low flow air pump at 200 mL/minute or an aspirator squeeze bulb. Many commercial test kits include an aspirator bulb, which is subject to variation in frequency, depth of squeeze, fatigue rate, and individual hand strength. Previous studies on irritant smoke used a handheld squeeze bulb. This study evaluated the effectiveness of a low flow pump for irritant smoke fit-testing. Twenty subjects wearing North 7600 series full-face respirators equipped with P100 filters were fit-tested with a Portacount Plus to ensure adequate fit. After successful fit was demonstrated, the exhalation valve was replaced with a damaged valve and/or rotated approximately 90 degrees to produce a fit factor below 100. Having induced an exhalation valve leak, the irritant smoke fit-test was performed using the OSHA irritant smoke protocol. To avoid introducing additional unknown leakage, all head movement exercises were replaced with the head straight, normal breathing maneuver. Irritant smoke did not detect 40 percent of respirators with leaking exhalation valves. Sixty percent of the subjects were able to detect the irritant smoke. Test sensitivity was 60 percent, well below the recommended 95 percent criterion. Of the 12 subjects that detected irritant smoke, none detected the smoke in less than a minute; the average detection time was 3 min 5 s. Some subjects were able to suppress the cough reflex. These findings suggest that qualitative fit-testing using irritant smoke with a 200 ml/min continuous flow pump does not have adequate sensitivity to detect fit factors less than 100.

Determination of known exhalation valve damage using a negative pressure user seal check method on full facepiece respirators.

A negative pressure user seal check (NPUSC) method was evaluated for its ability to adequately detect known exhalation valve leakage into a respirator. Three valves with different types of damage were included. Twenty-six test subjects, wearing full facepiece respirators, were asked to perform a NPUSC. Their responses as to whether they passed or failed the user seal check were compared to fit testing results from two quantitative fit test methods: ambient aerosol and controlled negative pressure. In addition, equipment developed at the University of Cincinnati was used to measure in-mask pressures that are generated during the performance of NPUSCs. This technique was employed to assess the ability of respirator wearers to properly conduct user seal checks. The data were analyzed to determine if the user seal check procedure is an effective method for detecting known exhalation valve damage. All test subjects reported passing the user seal check with the undamaged valve. With the warped valve installed, 95 percent of test subjects reported passing the user seal check. With the slit valve installed, 73 percent of test subjects reported passing. With the dirty valve installed, 65 percent reported passing. All fit factors, measured with the damaged valves, were below the Occupational Safety and Health Administration-recognized pass/fail criteria except one fit test with the respirator equipped with the slit valve. Results from the in-mask pressure measurements confirmed whether or not the subject properly conducted a user seal check, but did not detect respirator leakage. In conclusion, the performance of a NPUSC rarely helped to identify damaged exhalation valves. These results support the need for respirator inspection prior to donning with periodic fit testing and the performance of user seal checks as necessary components of an adequate respiratory protection program.