Clinical Safety and Performance Evaluation of New Personal Protective Equipment During the COVID-19 Pandemic
Abstract As the healthcare response to the COVID-19 pandemic continues, providing enhanced protection to frontline healthcare personnel exposed to aerosolized infectious material is essential. The rapid spread of the COVID-19 virus across the globe in early 2020 generated an overwhelming surge in de...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Topaz, Moris [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2023 |
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| Schlagwörter: |
Frontline healthcare personnel |
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| Anmerkung: |
© The Institution of Engineers (India) 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. |
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| Übergeordnetes Werk: |
Enthalten in: Journal of the Institution of Engineers (India) - [New Delhi] : Springer India, 2012, 104(2023), 1 vom: 02. Jan., Seite 93-100 |
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| Übergeordnetes Werk: |
volume:104 ; year:2023 ; number:1 ; day:02 ; month:01 ; pages:93-100 |
| Links: |
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| DOI / URN: |
10.1007/s40032-022-00906-9 |
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| Katalog-ID: |
SPR049203843 |
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| 520 | |a Abstract As the healthcare response to the COVID-19 pandemic continues, providing enhanced protection to frontline healthcare personnel exposed to aerosolized infectious material is essential. The rapid spread of the COVID-19 virus across the globe in early 2020 generated an overwhelming surge in demand for effective personal protective equipment (PPE), in particular, passive personal respirators (PPR). Global manufacturing of PPR was limited, and research and development of improved respirators were restricted by the availability of accredited laboratories for timely testing at the peak of the pandemic. The authors have described a clinical method of safety and efficacy testing of a new PPR, the TopBioShield, using portable capnography for the measurement of end-tidal $ pCO_{2} $ ($ ETCO_{2} $) and bedside pulse oximetry to measure oxygen saturation ($ SpO_{2} $), respiratory rate (RR), and heart rate (HR) in healthy volunteers to overcome shortages of clinical testing capabilities during the height of the pandemic. Twenty-eight volunteers with a median age of 41 years (range 16–71) representing all 10 subgroups of head/face size were included. Only one participant asked to withdraw due to a feeling of claustrophobia after 30 min. Clinical monitoring while wearing TopBioShield revealed $ ETCO_{2} $, $ SpO_{2} $, respiratory rate, and heart rate measurements were within normal limits in all the subjects throughout the experiment. Bedside clinical monitoring is effective in demonstrating the physiological safety of PPR and is an important alternative to conventional mannequin testing. In this study all measured values over a 90-min experiment period were within normal limits, demonstrating the effectiveness of TopBioShield in preventing $ CO_{2} $ retention. Clinical testing methods must adhere to the highest standards and are essential during times of shortage. | ||
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| 650 | 4 | |a Frontline healthcare personnel |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Personal protective equipment (PPE) |7 (dpeaa)DE-He213 | |
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| 700 | 1 | |a Levin, Gal Sahaf |4 aut | |
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10.1007/s40032-022-00906-9 doi (DE-627)SPR049203843 (SPR)s40032-022-00906-9-e DE-627 ger DE-627 rakwb eng Topaz, Moris verfasserin aut Clinical Safety and Performance Evaluation of New Personal Protective Equipment During the COVID-19 Pandemic 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Institution of Engineers (India) 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. Abstract As the healthcare response to the COVID-19 pandemic continues, providing enhanced protection to frontline healthcare personnel exposed to aerosolized infectious material is essential. The rapid spread of the COVID-19 virus across the globe in early 2020 generated an overwhelming surge in demand for effective personal protective equipment (PPE), in particular, passive personal respirators (PPR). Global manufacturing of PPR was limited, and research and development of improved respirators were restricted by the availability of accredited laboratories for timely testing at the peak of the pandemic. The authors have described a clinical method of safety and efficacy testing of a new PPR, the TopBioShield, using portable capnography for the measurement of end-tidal $ pCO_{2} $ ($ ETCO_{2} $) and bedside pulse oximetry to measure oxygen saturation ($ SpO_{2} $), respiratory rate (RR), and heart rate (HR) in healthy volunteers to overcome shortages of clinical testing capabilities during the height of the pandemic. Twenty-eight volunteers with a median age of 41 years (range 16–71) representing all 10 subgroups of head/face size were included. Only one participant asked to withdraw due to a feeling of claustrophobia after 30 min. Clinical monitoring while wearing TopBioShield revealed $ ETCO_{2} $, $ SpO_{2} $, respiratory rate, and heart rate measurements were within normal limits in all the subjects throughout the experiment. Bedside clinical monitoring is effective in demonstrating the physiological safety of PPR and is an important alternative to conventional mannequin testing. In this study all measured values over a 90-min experiment period were within normal limits, demonstrating the effectiveness of TopBioShield in preventing $ CO_{2} $ retention. Clinical testing methods must adhere to the highest standards and are essential during times of shortage. COVID-19 (dpeaa)DE-He213 Frontline healthcare personnel (dpeaa)DE-He213 Personal protective equipment (PPE) (dpeaa)DE-He213 Passive personal respirators (PPR) (dpeaa)DE-He213 Ashkenazi, Itamar aut Bibi, Haim aut Gurevich, Michael aut Lev, Shaul aut Gottesman, Tamar aut Levin, Gal Sahaf aut Biswas, Seema (orcid)0000-0003-2657-9818 aut Enthalten in Journal of the Institution of Engineers (India) [New Delhi] : Springer India, 2012 104(2023), 1 vom: 02. Jan., Seite 93-100 (DE-627)722236999 (DE-600)2677589-X 2250-0553 nnns volume:104 year:2023 number:1 day:02 month:01 pages:93-100 https://dx.doi.org/10.1007/s40032-022-00906-9 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 104 2023 1 02 01 93-100 |
| spelling |
10.1007/s40032-022-00906-9 doi (DE-627)SPR049203843 (SPR)s40032-022-00906-9-e DE-627 ger DE-627 rakwb eng Topaz, Moris verfasserin aut Clinical Safety and Performance Evaluation of New Personal Protective Equipment During the COVID-19 Pandemic 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Institution of Engineers (India) 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. Abstract As the healthcare response to the COVID-19 pandemic continues, providing enhanced protection to frontline healthcare personnel exposed to aerosolized infectious material is essential. The rapid spread of the COVID-19 virus across the globe in early 2020 generated an overwhelming surge in demand for effective personal protective equipment (PPE), in particular, passive personal respirators (PPR). Global manufacturing of PPR was limited, and research and development of improved respirators were restricted by the availability of accredited laboratories for timely testing at the peak of the pandemic. The authors have described a clinical method of safety and efficacy testing of a new PPR, the TopBioShield, using portable capnography for the measurement of end-tidal $ pCO_{2} $ ($ ETCO_{2} $) and bedside pulse oximetry to measure oxygen saturation ($ SpO_{2} $), respiratory rate (RR), and heart rate (HR) in healthy volunteers to overcome shortages of clinical testing capabilities during the height of the pandemic. Twenty-eight volunteers with a median age of 41 years (range 16–71) representing all 10 subgroups of head/face size were included. Only one participant asked to withdraw due to a feeling of claustrophobia after 30 min. Clinical monitoring while wearing TopBioShield revealed $ ETCO_{2} $, $ SpO_{2} $, respiratory rate, and heart rate measurements were within normal limits in all the subjects throughout the experiment. Bedside clinical monitoring is effective in demonstrating the physiological safety of PPR and is an important alternative to conventional mannequin testing. In this study all measured values over a 90-min experiment period were within normal limits, demonstrating the effectiveness of TopBioShield in preventing $ CO_{2} $ retention. Clinical testing methods must adhere to the highest standards and are essential during times of shortage. COVID-19 (dpeaa)DE-He213 Frontline healthcare personnel (dpeaa)DE-He213 Personal protective equipment (PPE) (dpeaa)DE-He213 Passive personal respirators (PPR) (dpeaa)DE-He213 Ashkenazi, Itamar aut Bibi, Haim aut Gurevich, Michael aut Lev, Shaul aut Gottesman, Tamar aut Levin, Gal Sahaf aut Biswas, Seema (orcid)0000-0003-2657-9818 aut Enthalten in Journal of the Institution of Engineers (India) [New Delhi] : Springer India, 2012 104(2023), 1 vom: 02. Jan., Seite 93-100 (DE-627)722236999 (DE-600)2677589-X 2250-0553 nnns volume:104 year:2023 number:1 day:02 month:01 pages:93-100 https://dx.doi.org/10.1007/s40032-022-00906-9 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 104 2023 1 02 01 93-100 |
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10.1007/s40032-022-00906-9 doi (DE-627)SPR049203843 (SPR)s40032-022-00906-9-e DE-627 ger DE-627 rakwb eng Topaz, Moris verfasserin aut Clinical Safety and Performance Evaluation of New Personal Protective Equipment During the COVID-19 Pandemic 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Institution of Engineers (India) 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. Abstract As the healthcare response to the COVID-19 pandemic continues, providing enhanced protection to frontline healthcare personnel exposed to aerosolized infectious material is essential. The rapid spread of the COVID-19 virus across the globe in early 2020 generated an overwhelming surge in demand for effective personal protective equipment (PPE), in particular, passive personal respirators (PPR). Global manufacturing of PPR was limited, and research and development of improved respirators were restricted by the availability of accredited laboratories for timely testing at the peak of the pandemic. The authors have described a clinical method of safety and efficacy testing of a new PPR, the TopBioShield, using portable capnography for the measurement of end-tidal $ pCO_{2} $ ($ ETCO_{2} $) and bedside pulse oximetry to measure oxygen saturation ($ SpO_{2} $), respiratory rate (RR), and heart rate (HR) in healthy volunteers to overcome shortages of clinical testing capabilities during the height of the pandemic. Twenty-eight volunteers with a median age of 41 years (range 16–71) representing all 10 subgroups of head/face size were included. Only one participant asked to withdraw due to a feeling of claustrophobia after 30 min. Clinical monitoring while wearing TopBioShield revealed $ ETCO_{2} $, $ SpO_{2} $, respiratory rate, and heart rate measurements were within normal limits in all the subjects throughout the experiment. Bedside clinical monitoring is effective in demonstrating the physiological safety of PPR and is an important alternative to conventional mannequin testing. In this study all measured values over a 90-min experiment period were within normal limits, demonstrating the effectiveness of TopBioShield in preventing $ CO_{2} $ retention. Clinical testing methods must adhere to the highest standards and are essential during times of shortage. COVID-19 (dpeaa)DE-He213 Frontline healthcare personnel (dpeaa)DE-He213 Personal protective equipment (PPE) (dpeaa)DE-He213 Passive personal respirators (PPR) (dpeaa)DE-He213 Ashkenazi, Itamar aut Bibi, Haim aut Gurevich, Michael aut Lev, Shaul aut Gottesman, Tamar aut Levin, Gal Sahaf aut Biswas, Seema (orcid)0000-0003-2657-9818 aut Enthalten in Journal of the Institution of Engineers (India) [New Delhi] : Springer India, 2012 104(2023), 1 vom: 02. Jan., Seite 93-100 (DE-627)722236999 (DE-600)2677589-X 2250-0553 nnns volume:104 year:2023 number:1 day:02 month:01 pages:93-100 https://dx.doi.org/10.1007/s40032-022-00906-9 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 104 2023 1 02 01 93-100 |
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10.1007/s40032-022-00906-9 doi (DE-627)SPR049203843 (SPR)s40032-022-00906-9-e DE-627 ger DE-627 rakwb eng Topaz, Moris verfasserin aut Clinical Safety and Performance Evaluation of New Personal Protective Equipment During the COVID-19 Pandemic 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Institution of Engineers (India) 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. Abstract As the healthcare response to the COVID-19 pandemic continues, providing enhanced protection to frontline healthcare personnel exposed to aerosolized infectious material is essential. The rapid spread of the COVID-19 virus across the globe in early 2020 generated an overwhelming surge in demand for effective personal protective equipment (PPE), in particular, passive personal respirators (PPR). Global manufacturing of PPR was limited, and research and development of improved respirators were restricted by the availability of accredited laboratories for timely testing at the peak of the pandemic. The authors have described a clinical method of safety and efficacy testing of a new PPR, the TopBioShield, using portable capnography for the measurement of end-tidal $ pCO_{2} $ ($ ETCO_{2} $) and bedside pulse oximetry to measure oxygen saturation ($ SpO_{2} $), respiratory rate (RR), and heart rate (HR) in healthy volunteers to overcome shortages of clinical testing capabilities during the height of the pandemic. Twenty-eight volunteers with a median age of 41 years (range 16–71) representing all 10 subgroups of head/face size were included. Only one participant asked to withdraw due to a feeling of claustrophobia after 30 min. Clinical monitoring while wearing TopBioShield revealed $ ETCO_{2} $, $ SpO_{2} $, respiratory rate, and heart rate measurements were within normal limits in all the subjects throughout the experiment. Bedside clinical monitoring is effective in demonstrating the physiological safety of PPR and is an important alternative to conventional mannequin testing. In this study all measured values over a 90-min experiment period were within normal limits, demonstrating the effectiveness of TopBioShield in preventing $ CO_{2} $ retention. Clinical testing methods must adhere to the highest standards and are essential during times of shortage. COVID-19 (dpeaa)DE-He213 Frontline healthcare personnel (dpeaa)DE-He213 Personal protective equipment (PPE) (dpeaa)DE-He213 Passive personal respirators (PPR) (dpeaa)DE-He213 Ashkenazi, Itamar aut Bibi, Haim aut Gurevich, Michael aut Lev, Shaul aut Gottesman, Tamar aut Levin, Gal Sahaf aut Biswas, Seema (orcid)0000-0003-2657-9818 aut Enthalten in Journal of the Institution of Engineers (India) [New Delhi] : Springer India, 2012 104(2023), 1 vom: 02. Jan., Seite 93-100 (DE-627)722236999 (DE-600)2677589-X 2250-0553 nnns volume:104 year:2023 number:1 day:02 month:01 pages:93-100 https://dx.doi.org/10.1007/s40032-022-00906-9 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 104 2023 1 02 01 93-100 |
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10.1007/s40032-022-00906-9 doi (DE-627)SPR049203843 (SPR)s40032-022-00906-9-e DE-627 ger DE-627 rakwb eng Topaz, Moris verfasserin aut Clinical Safety and Performance Evaluation of New Personal Protective Equipment During the COVID-19 Pandemic 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Institution of Engineers (India) 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. Abstract As the healthcare response to the COVID-19 pandemic continues, providing enhanced protection to frontline healthcare personnel exposed to aerosolized infectious material is essential. The rapid spread of the COVID-19 virus across the globe in early 2020 generated an overwhelming surge in demand for effective personal protective equipment (PPE), in particular, passive personal respirators (PPR). Global manufacturing of PPR was limited, and research and development of improved respirators were restricted by the availability of accredited laboratories for timely testing at the peak of the pandemic. The authors have described a clinical method of safety and efficacy testing of a new PPR, the TopBioShield, using portable capnography for the measurement of end-tidal $ pCO_{2} $ ($ ETCO_{2} $) and bedside pulse oximetry to measure oxygen saturation ($ SpO_{2} $), respiratory rate (RR), and heart rate (HR) in healthy volunteers to overcome shortages of clinical testing capabilities during the height of the pandemic. Twenty-eight volunteers with a median age of 41 years (range 16–71) representing all 10 subgroups of head/face size were included. Only one participant asked to withdraw due to a feeling of claustrophobia after 30 min. Clinical monitoring while wearing TopBioShield revealed $ ETCO_{2} $, $ SpO_{2} $, respiratory rate, and heart rate measurements were within normal limits in all the subjects throughout the experiment. Bedside clinical monitoring is effective in demonstrating the physiological safety of PPR and is an important alternative to conventional mannequin testing. In this study all measured values over a 90-min experiment period were within normal limits, demonstrating the effectiveness of TopBioShield in preventing $ CO_{2} $ retention. Clinical testing methods must adhere to the highest standards and are essential during times of shortage. COVID-19 (dpeaa)DE-He213 Frontline healthcare personnel (dpeaa)DE-He213 Personal protective equipment (PPE) (dpeaa)DE-He213 Passive personal respirators (PPR) (dpeaa)DE-He213 Ashkenazi, Itamar aut Bibi, Haim aut Gurevich, Michael aut Lev, Shaul aut Gottesman, Tamar aut Levin, Gal Sahaf aut Biswas, Seema (orcid)0000-0003-2657-9818 aut Enthalten in Journal of the Institution of Engineers (India) [New Delhi] : Springer India, 2012 104(2023), 1 vom: 02. Jan., Seite 93-100 (DE-627)722236999 (DE-600)2677589-X 2250-0553 nnns volume:104 year:2023 number:1 day:02 month:01 pages:93-100 https://dx.doi.org/10.1007/s40032-022-00906-9 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 104 2023 1 02 01 93-100 |
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Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Abstract As the healthcare response to the COVID-19 pandemic continues, providing enhanced protection to frontline healthcare personnel exposed to aerosolized infectious material is essential. The rapid spread of the COVID-19 virus across the globe in early 2020 generated an overwhelming surge in demand for effective personal protective equipment (PPE), in particular, passive personal respirators (PPR). Global manufacturing of PPR was limited, and research and development of improved respirators were restricted by the availability of accredited laboratories for timely testing at the peak of the pandemic. The authors have described a clinical method of safety and efficacy testing of a new PPR, the TopBioShield, using portable capnography for the measurement of end-tidal $ pCO_{2} $ ($ ETCO_{2} $) and bedside pulse oximetry to measure oxygen saturation ($ SpO_{2} $), respiratory rate (RR), and heart rate (HR) in healthy volunteers to overcome shortages of clinical testing capabilities during the height of the pandemic. Twenty-eight volunteers with a median age of 41 years (range 16–71) representing all 10 subgroups of head/face size were included. Only one participant asked to withdraw due to a feeling of claustrophobia after 30 min. Clinical monitoring while wearing TopBioShield revealed $ ETCO_{2} $, $ SpO_{2} $, respiratory rate, and heart rate measurements were within normal limits in all the subjects throughout the experiment. Bedside clinical monitoring is effective in demonstrating the physiological safety of PPR and is an important alternative to conventional mannequin testing. In this study all measured values over a 90-min experiment period were within normal limits, demonstrating the effectiveness of TopBioShield in preventing $ CO_{2} $ retention. 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Topaz, Moris |
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clinical safety and performance evaluation of new personal protective equipment during the covid-19 pandemic |
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Clinical Safety and Performance Evaluation of New Personal Protective Equipment During the COVID-19 Pandemic |
| abstract |
Abstract As the healthcare response to the COVID-19 pandemic continues, providing enhanced protection to frontline healthcare personnel exposed to aerosolized infectious material is essential. The rapid spread of the COVID-19 virus across the globe in early 2020 generated an overwhelming surge in demand for effective personal protective equipment (PPE), in particular, passive personal respirators (PPR). Global manufacturing of PPR was limited, and research and development of improved respirators were restricted by the availability of accredited laboratories for timely testing at the peak of the pandemic. The authors have described a clinical method of safety and efficacy testing of a new PPR, the TopBioShield, using portable capnography for the measurement of end-tidal $ pCO_{2} $ ($ ETCO_{2} $) and bedside pulse oximetry to measure oxygen saturation ($ SpO_{2} $), respiratory rate (RR), and heart rate (HR) in healthy volunteers to overcome shortages of clinical testing capabilities during the height of the pandemic. Twenty-eight volunteers with a median age of 41 years (range 16–71) representing all 10 subgroups of head/face size were included. Only one participant asked to withdraw due to a feeling of claustrophobia after 30 min. Clinical monitoring while wearing TopBioShield revealed $ ETCO_{2} $, $ SpO_{2} $, respiratory rate, and heart rate measurements were within normal limits in all the subjects throughout the experiment. Bedside clinical monitoring is effective in demonstrating the physiological safety of PPR and is an important alternative to conventional mannequin testing. In this study all measured values over a 90-min experiment period were within normal limits, demonstrating the effectiveness of TopBioShield in preventing $ CO_{2} $ retention. Clinical testing methods must adhere to the highest standards and are essential during times of shortage. © The Institution of Engineers (India) 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. |
| abstractGer |
Abstract As the healthcare response to the COVID-19 pandemic continues, providing enhanced protection to frontline healthcare personnel exposed to aerosolized infectious material is essential. The rapid spread of the COVID-19 virus across the globe in early 2020 generated an overwhelming surge in demand for effective personal protective equipment (PPE), in particular, passive personal respirators (PPR). Global manufacturing of PPR was limited, and research and development of improved respirators were restricted by the availability of accredited laboratories for timely testing at the peak of the pandemic. The authors have described a clinical method of safety and efficacy testing of a new PPR, the TopBioShield, using portable capnography for the measurement of end-tidal $ pCO_{2} $ ($ ETCO_{2} $) and bedside pulse oximetry to measure oxygen saturation ($ SpO_{2} $), respiratory rate (RR), and heart rate (HR) in healthy volunteers to overcome shortages of clinical testing capabilities during the height of the pandemic. Twenty-eight volunteers with a median age of 41 years (range 16–71) representing all 10 subgroups of head/face size were included. Only one participant asked to withdraw due to a feeling of claustrophobia after 30 min. Clinical monitoring while wearing TopBioShield revealed $ ETCO_{2} $, $ SpO_{2} $, respiratory rate, and heart rate measurements were within normal limits in all the subjects throughout the experiment. Bedside clinical monitoring is effective in demonstrating the physiological safety of PPR and is an important alternative to conventional mannequin testing. In this study all measured values over a 90-min experiment period were within normal limits, demonstrating the effectiveness of TopBioShield in preventing $ CO_{2} $ retention. Clinical testing methods must adhere to the highest standards and are essential during times of shortage. © The Institution of Engineers (India) 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. |
| abstract_unstemmed |
Abstract As the healthcare response to the COVID-19 pandemic continues, providing enhanced protection to frontline healthcare personnel exposed to aerosolized infectious material is essential. The rapid spread of the COVID-19 virus across the globe in early 2020 generated an overwhelming surge in demand for effective personal protective equipment (PPE), in particular, passive personal respirators (PPR). Global manufacturing of PPR was limited, and research and development of improved respirators were restricted by the availability of accredited laboratories for timely testing at the peak of the pandemic. The authors have described a clinical method of safety and efficacy testing of a new PPR, the TopBioShield, using portable capnography for the measurement of end-tidal $ pCO_{2} $ ($ ETCO_{2} $) and bedside pulse oximetry to measure oxygen saturation ($ SpO_{2} $), respiratory rate (RR), and heart rate (HR) in healthy volunteers to overcome shortages of clinical testing capabilities during the height of the pandemic. Twenty-eight volunteers with a median age of 41 years (range 16–71) representing all 10 subgroups of head/face size were included. Only one participant asked to withdraw due to a feeling of claustrophobia after 30 min. Clinical monitoring while wearing TopBioShield revealed $ ETCO_{2} $, $ SpO_{2} $, respiratory rate, and heart rate measurements were within normal limits in all the subjects throughout the experiment. Bedside clinical monitoring is effective in demonstrating the physiological safety of PPR and is an important alternative to conventional mannequin testing. In this study all measured values over a 90-min experiment period were within normal limits, demonstrating the effectiveness of TopBioShield in preventing $ CO_{2} $ retention. Clinical testing methods must adhere to the highest standards and are essential during times of shortage. © The Institution of Engineers (India) 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. |
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Clinical Safety and Performance Evaluation of New Personal Protective Equipment During the COVID-19 Pandemic |
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https://dx.doi.org/10.1007/s40032-022-00906-9 |
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Ashkenazi, Itamar Bibi, Haim Gurevich, Michael Lev, Shaul Gottesman, Tamar Levin, Gal Sahaf Biswas, Seema |
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Ashkenazi, Itamar Bibi, Haim Gurevich, Michael Lev, Shaul Gottesman, Tamar Levin, Gal Sahaf Biswas, Seema |
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10.1007/s40032-022-00906-9 |
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| score |
7.3995686 |