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  1. Artikel: Accuracy of Samsung Smartphone Integrated Pulse Oximetry Meets Full FDA Clearance Standards for Clinical Use.

    Browne, Sara H / Bernstein, Mike / Bickler, Philip E

    medRxiv : the preprint server for health sciences

    2021  

    Abstract: Background: Pulse oximetry is used as an assessment tool to gauge the severity of COVID-19 infection and identify patients at risk of poor outcomes.: Methods: The accuracy of integrated pulse oximetry in the Samsung 9 smartphone during stable ... ...

    Abstract Background: Pulse oximetry is used as an assessment tool to gauge the severity of COVID-19 infection and identify patients at risk of poor outcomes.
    Methods: The accuracy of integrated pulse oximetry in the Samsung 9 smartphone during stable arterial oxygen saturations (SaO
    Findings: The RMSD of the over 257 data points based on blood sample analysis obtained from 12 human volunteers tested was 2.6%.
    Interpretation: Evaluation of the smartphone pulse oximeter performance is within requirements of <3.5% RMSD blood oxygen saturation (SpO
    Sprache Englisch
    Erscheinungsdatum 2021-02-18
    Erscheinungsland United States
    Dokumenttyp Preprint
    DOI 10.1101/2021.02.17.21249755
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  2. Artikel ; Online: Accuracy of Smartphone Integrated Pulse Oximetry Meets Full FDA Clearance Standards for Clinical Use.

    Browne, Sara H / Bernstein, Mike / Bickler, Philip E.

    medRxiv

    Abstract: Background: Pulse oximetry is used as an assessment tool to gauge the severity of COVID-19 infection and identify patients at risk of poor outcomes. The pandemic highlights the need for accurate pulse oximetry, particularly at home, as infection rates ... ...

    Abstract Background: Pulse oximetry is used as an assessment tool to gauge the severity of COVID-19 infection and identify patients at risk of poor outcomes. The pandemic highlights the need for accurate pulse oximetry, particularly at home, as infection rates increase in multiple global regions, including the UK, USA, and South Africa. Over 100 million Samsung smartphones containing dedicated biosensors (Maxim Integrated Inc, San Jose, CA) and preloaded Apps to perform pulse oximetry, are in use globally. We performed detailed in human hypoxia testing on the Samsung S9 smartphone to determine if this integrated hardware meets full FDA/ISO requirements for clinical pulse oximetry. Methods: The accuracy of integrated pulse oximetry in the Samsung 9+ smartphone during stable oxygen saturation (SaO2) between 70% and 100% was evaluated in 12 healthy subjects. Inspired oxygen, nitrogen, and carbon dioxide partial pressures were monitored and adjusted via a partial rebreathing circuit to achieve stable target SaO2 plateaus between 70% and 100%. Arterial blood samples were taken at each plateau, and saturation measured on each blood sample using ABL-90FLEX blood gas analyzer. Bias, calculated from smartphone readings minus the corresponding arterial blood sample, was reported as root mean square deviation (RMSD). Findings: The RMSD of the over 257 data points based on blood sample analysis obtained from 12 human volunteers tested was 2.6%. Interpretation: Evaluation of the smartphone pulse oximeter performance is within requirements of <3.5% RMSD blood oxygen saturation (SpO2) value for FDA/ISO clearance for clinical pulse oximetry. This is the first report of smartphone derived pulse oximetry measurements that meet full FDA/ISO accuracy certification requirements. Both Samsung S9 and S10 contain the same integrated pulse oximeter, thus over 100 million smartphones in current global circulation could be used to obtain clinically accurate spot SpO2 measurements to support at home assessment of COVID-19 patients.
    Schlagwörter covid19
    Sprache Englisch
    Erscheinungsdatum 2021-02-18
    Verlag Cold Spring Harbor Laboratory Press
    Dokumenttyp Artikel ; Online
    DOI 10.1101/2021.02.17.21249755
    Datenquelle COVID19

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  3. Artikel ; Online: Designing a Smartphone-Based Pulse Oximeter for Children in South Africa (Phefumla Project): Qualitative Analysis of Human-Centered Design Workshops With Health Care Workers.

    Ilhan, Elif I / Jola, Lucia N / van der Zalm, Marieke M / Bernstein, Mike / Goussard, Pierre / Redfern, Andrew / Hesseling, Anneke C / Hoddinott, Graeme / McCollum, Eric D / King, Carina

    JMIR human factors

    2024  Band 11, Seite(n) e54983

    Abstract: Background: Pulse oximeters noninvasively measure blood oxygen levels, but these devices have rarely been designed for low-resource settings and are inconsistently available at outpatient clinics.: Objective: The Phefumla project aims to develop and ... ...

    Abstract Background: Pulse oximeters noninvasively measure blood oxygen levels, but these devices have rarely been designed for low-resource settings and are inconsistently available at outpatient clinics.
    Objective: The Phefumla project aims to develop and validate a pediatric smartphone-based pulse oximeter designed specifically for this context. We present the process of human-centered oximeter design with health care workers in South Africa.
    Methods: We purposively sampled 19 health care workers from 5 clinics in Khayelitsha, Cape Town. Using a human-centered design approach, we conducted participatory workshops with four activities with health care workers: (1) they received 3D-printed prototypes of potential oximeter designs to provide feedback; (2) we demonstrated on dolls how they would use the novel oximeter; (3) they used pile sorting to rank design features and suggest additional features they desired; and (4) they designed their preferred user interface using a whiteboard, marker, and magnetized features that could be repositioned. We audio recorded the workshops, photographed outputs, and took detailed field notes. Analysis involved iterative review of these data to describe preferences, identify key design updates, and provide modifications.
    Results: Participants expressed a positive sentiment toward the idea of a smartphone pulse oximeter and suggested that a pediatric device would address an important gap in outpatient care. Specifically, participants expressed a preference for the prototype that they felt enabled more diversity in the way it could be used. There was a strong tendency to prioritize pragmatic design features, such as robustness, which was largely dictated by health care worker context. They also added features that would allow the oximeter device to serve other clinical functions in addition to oxygen saturation measurement, such as temperature and respiratory rate measurements.
    Conclusions: Our end user-centered rapid participatory approach led to tangible design changes and prompted design discussions that the team had not previously considered. Overall, health care workers prioritized pragmatism for pediatric pulse oximeter device design.
    Mesh-Begriff(e) Humans ; South Africa ; Smartphone ; Oximetry/instrumentation ; Oximetry/methods ; Health Personnel ; Equipment Design ; Qualitative Research ; User-Centered Design ; Child ; Female ; Male
    Sprache Englisch
    Erscheinungsdatum 2024-05-30
    Erscheinungsland Canada
    Dokumenttyp Journal Article
    ISSN 2292-9495
    ISSN (online) 2292-9495
    DOI 10.2196/54983
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  4. Artikel ; Online: Smartphone Biosensor With App Meets FDA/ISO Standards for Clinical Pulse Oximetry and Can Be Reliably Used by a Wide Range of Patients.

    Browne, Sara H / Bernstein, Mike / Pan, Samuel C / Gonzalez Garcia, Jonathan / Easson, Craig A / Huang, Chung-Che / Vaida, Florin

    Chest

    2020  Band 159, Heft 2, Seite(n) 724–732

    Abstract: Background: Millions of smartphones contain a photoplethysmography (PPG) biosensor (Maxim Integrated) that accurately measures pulse oximetry. No clinical use of these embedded sensors is currently being made, despite the relevance of remote clinical ... ...

    Abstract Background: Millions of smartphones contain a photoplethysmography (PPG) biosensor (Maxim Integrated) that accurately measures pulse oximetry. No clinical use of these embedded sensors is currently being made, despite the relevance of remote clinical pulse oximetry to the management of chronic cardiopulmonary disease, and the triage, initial management, and remote monitoring of people affected by respiratory viral pandemics, such as severe acute respiratory syndrome coronavirus 2 or influenza. To be used for clinical pulse oximetry the embedded PPG system must be paired with an application (app) and meet US Food and Drug Administration (FDA) and International Organization for Standardization (ISO) requirements.
    Research question: Does this smartphone sensor with app meet FDA/ISO requirements? Are measurements obtained using this system comparable to those of hospital reference devices, across a wide range of people?
    Study design and methods: We performed laboratory testing addressing ISO and FDA requirements in 10 participants using the smartphone sensor with app. Subsequently, we performed an open-label clinical study on 320 participants with widely varying characteristics, to compare the accuracy and precision of readings obtained by patients with those of hospital reference devices, using rigorous statistical methodology.
    Results: "Breathe down" testing in the laboratory showed that the total root-mean-square deviation of oxygen saturation (Spo
    Interpretation: Our findings support the application for full FDA/ISO approval of the smartphone sensor with app tested for use in clinical pulse oximetry. Given the immense and immediate practical medical importance of remote intermittent clinical pulse oximetry to both chronic disease management and the global ability to respond to respiratory viral pandemics, the smartphone sensor with app should be prioritized and fast-tracked for FDA/ISO approval to allow clinical use.
    Trial registry: ClinicalTrials.gov; No.: NCT04233827; URL: www.clinicaltrials.gov.
    Mesh-Begriff(e) Adolescent ; Adult ; Aged ; Aged, 80 and over ; Biosensing Techniques ; Device Approval ; Female ; Humans ; Male ; Middle Aged ; Mobile Applications ; Oximetry/instrumentation ; Oximetry/standards ; Photoplethysmography/instrumentation ; Photoplethysmography/standards ; Smartphone ; United States ; United States Food and Drug Administration ; Young Adult
    Schlagwörter covid19
    Sprache Englisch
    Erscheinungsdatum 2020-09-11
    Erscheinungsland United States
    Dokumenttyp Journal Article
    ZDB-ID 1032552-9
    ISSN 1931-3543 ; 0012-3692
    ISSN (online) 1931-3543
    ISSN 0012-3692
    DOI 10.1016/j.chest.2020.08.2104
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  5. Artikel ; Online: Pulse oximetry in paediatric primary care in low-income and middle-income countries.

    McCollum, Eric D / King, Carina / Colbourn, Tim / Graham, Hamish / Bernstein, Mike / Wilson, Iain H / Checkley, William

    The Lancet. Respiratory medicine

    2019  Band 7, Heft 12, Seite(n) 1001–1002

    Mesh-Begriff(e) Child ; Child Health Services/organization & administration ; Child, Preschool ; Developing Countries ; Humans ; Oximetry/economics ; Poverty ; Primary Health Care/organization & administration
    Sprache Englisch
    Erscheinungsdatum 2019-10-17
    Erscheinungsland England
    Dokumenttyp Journal Article
    ZDB-ID 2686754-0
    ISSN 2213-2619 ; 2213-2600
    ISSN (online) 2213-2619
    ISSN 2213-2600
    DOI 10.1016/S2213-2600(19)30358-3
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  6. Artikel: Maxim Integrated Smartphone Sensor with App Meets FDA/ISO Standards for Clinical Pulse Oximetry and can be Reliably Utilized by a Wide Range of Patients

    Browne, Sara H / Bernstein, Mike / Pan, Samuel C / Garcia, Jonathan Gonzalez / Easson, Craig A / Huang, Chung-Che / Vaida, Florin

    Chest

    Abstract: BACKGROUND: Millions of smartphones contain a photoplethysmography (PPG) bio-sensor (Maxim Integrated, San Jose CA) that accurately measures pulse oximetry. No clinical use of these embedded sensors is currently being made, despite the relevance of ... ...

    Abstract BACKGROUND: Millions of smartphones contain a photoplethysmography (PPG) bio-sensor (Maxim Integrated, San Jose CA) that accurately measures pulse oximetry. No clinical use of these embedded sensors is currently being made, despite the relevance of remote clinical pulse oximetry to the management of chronic cardiopulmonary disease, and the triage, initial management and remote monitoring of persons effected by respiratory viral pandemics, such as SARS-CoV-2 or Influenza. To be used for clinical pulse oximetry the embedded PPG system must be paired with an App and meet FDA and ISO requirements. RESEARCH QUESTION: We evaluated whether this smartphone sensor with App met FDA/ISO requirements and how measurements obtained using this system compared to hospital reference devices across a wide range of persons. STUDY DESIGN AND METHODS: We performed laboratory testing addressing ISO and FDA requirements in ten participants using the smartphone sensor with App. Subsequently, we performed an open label clinical study on 320 participants with widely varying characteristics, to compare accuracy and precision of readings obtained by patients, to hospital reference devices using a rigorous statistical methodology. RESULTS: 'Breathe Down' testing in the laboratory showed that the total Root Mean Square Deviation (RSMD) of SpO2 measurement was 2.02%, meeting FDA/ISO standards. Clinical comparison of the smartphone sensor with App versus hospital reference devices determined SpO2 and heart rate (HR) accuracy was 0.48 % points (CI 0.38 to 0.58; p<0.001) and 0.73 bpm (CI 0.33 to 1.14; p<0.001) respectively; with SpO2 and HR precision 1.25 versus reference 0.95 points (p< 0.001) and 5.99 versus reference 3.80 bpm (p<0.001), respectively. These small differences were similar to the variation found between two FDA approved reference instruments for SpO2: accuracy 0.52 points (CI 0.41 to 0.64; p<0.001) and precision 1.01 versus 0.86 (p<0.001). INTERPRETATION: Our findings support the application for full FDA/ISO approval of the smartphone sensor with App tested for use in clinical pulse oximetry. Given the immense and immediate practical medical importance of remote intermittent clinical pulse oximetry to both chronic disease management and the global ability to respond to respiratory viral pandemics, the smartphone sensor with APP should be prioritized and fast tracked for FDA/ ISO approval to allow clinical use.
    Schlagwörter covid19
    Verlag WHO
    Dokumenttyp Artikel
    Anmerkung WHO #Covidence: #753798
    Datenquelle COVID19

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  7. Artikel ; Online: Performance of a novel reusable pediatric pulse oximeter probe.

    King, Carina / Mvalo, Tisungane / Sessions, Kristen / Wilson, Iain / Walker, Isabeau / Zadutsa, Beatiwel / Makwenda, Charles / Phiri, Tambosi / Boyd, Nicholas / Bernstein, Mike / McCollum, Eric D

    Pediatric pulmonology

    2019  Band 54, Heft 7, Seite(n) 1052–1059

    Abstract: Objective: To assess the performance of reusable pulse oximeter probe and microprocessor box combinations, of varying price-points, in the context of a low-income pediatric setting.: Methods: A prospective, randomized cross-over study comparing time ... ...

    Abstract Objective: To assess the performance of reusable pulse oximeter probe and microprocessor box combinations, of varying price-points, in the context of a low-income pediatric setting.
    Methods: A prospective, randomized cross-over study comparing time to biologically plausible oxygen saturation (SpO
    Results: We recruited 572 children. Plausible SpO
    Conclusions: The novel reusable pediatric Lifebox probe can achieve a quality SpO
    Mesh-Begriff(e) Child, Preschool ; Cross-Over Studies ; Humans ; Infant ; Infant, Newborn ; Oximetry/instrumentation ; Oxygen/blood
    Chemische Substanzen Oxygen (S88TT14065)
    Sprache Englisch
    Erscheinungsdatum 2019-03-25
    Erscheinungsland United States
    Dokumenttyp Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 632784-9
    ISSN 1099-0496 ; 8755-6863
    ISSN (online) 1099-0496
    ISSN 8755-6863
    DOI 10.1002/ppul.24295
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  8. Artikel ; Online: Usability Testing of a Reusable Pulse Oximeter Probe Developed for Health-Care Workers Caring for Children < 5 Years Old in Low-Resource Settings.

    Boyd, Nicholas / King, Carina / Walker, Isabeau A / Zadutsa, Beatiwel / Bernstein, Mike / Ahmed, Salahuddin / Roy, Arunangshu / Hanif, Abu A M / Saha, Subal C / Majumder, Kingshuk / Nambiar, Bejoy / Colbourn, Tim / Makwenda, Charles / Baqui, Abdullah H / Wilson, Iain / McCollum, Eric D

    The American journal of tropical medicine and hygiene

    2018  Band 99, Heft 4, Seite(n) 1096–1104

    Abstract: Hypoxemia measured by pulse oximetry predicts child pneumonia mortality in low-resource settings (LRS). Existing pediatric oximeter probes are prohibitively expensive and/or difficult to use, limiting LRS implementation. Using a human-centered design, we ...

    Abstract Hypoxemia measured by pulse oximetry predicts child pneumonia mortality in low-resource settings (LRS). Existing pediatric oximeter probes are prohibitively expensive and/or difficult to use, limiting LRS implementation. Using a human-centered design, we developed a low-cost, reusable pediatric oximeter probe for LRS health-care workers (HCWs). Here, we report probe usability testing. Fifty-one HCWs from Malawi, Bangladesh, and the United Kingdom participated, and seven experts provided reference measurements. Health-care workers and experts measured the peripheral arterial oxyhemoglobin saturation (SpO
    Mesh-Begriff(e) Adult ; Bangladesh ; Child ; Equipment Reuse ; Health Personnel ; Humans ; Hypoxia/blood ; Hypoxia/diagnosis ; Hypoxia/economics ; Infant ; Infant, Newborn ; Laboratory Proficiency Testing/statistics & numerical data ; Logistic Models ; Malawi ; Oximetry/economics ; Oximetry/instrumentation ; Oxygen/blood ; Oxyhemoglobins/analysis ; Pneumonia/blood ; Pneumonia/diagnosis ; Pneumonia/economics ; United Kingdom
    Chemische Substanzen Oxyhemoglobins ; Oxygen (S88TT14065)
    Sprache Englisch
    Erscheinungsdatum 2018-08-23
    Erscheinungsland United States
    Dokumenttyp Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2942-7
    ISSN 1476-1645 ; 0002-9637
    ISSN (online) 1476-1645
    ISSN 0002-9637
    DOI 10.4269/ajtmh.18-0016
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  9. Artikel: Design of novel and potent cPLA₂α inhibitors containing an α-methyl-2-ketothiazole as a metabolically stable serine trap

    Mete, Antonio / Andrews, Glen / Bernstein, Mike / Connolly, Stephen / Hartopp, Paul / Jackson, Clive G / Lewis, Richard / Martin, Iain / Murray, David / Riley, Rob / Robinson, David H / Smith, Gill M / Wells, Edward / Withnall, W. John

    Bioorganic & medicinal chemistry letters. 2011 May 15, v. 21, no. 10

    2011  

    Abstract: We report the design of novel, potent cPLA₂α inhibitors that possess an α-methyl-2-ketothiazole that acts as a serine-reactive moiety. We describe the optimization of the series for potency and metabolic stability towards ketone reduction. This was ... ...

    Abstract We report the design of novel, potent cPLA₂α inhibitors that possess an α-methyl-2-ketothiazole that acts as a serine-reactive moiety. We describe the optimization of the series for potency and metabolic stability towards ketone reduction. This was achieved by attenuating the reactivity of the ketone using a combination of electronic and steric effects.
    Schlagwörter chemical reduction ; enzyme inhibitors ; ketones ; phospholipase A2 ; serine ; thiazoles
    Sprache Englisch
    Erscheinungsverlauf 2011-0515
    Umfang p. 3128-3133.
    Erscheinungsort Elsevier Ltd
    Dokumenttyp Artikel
    ZDB-ID 1063195-1
    ISSN 1464-3405 ; 0960-894X
    ISSN (online) 1464-3405
    ISSN 0960-894X
    DOI 10.1016/j.bmcl.2011.03.005
    Datenquelle NAL Katalog (AGRICOLA)

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  10. Artikel ; Online: Design of novel and potent cPLA2α inhibitors containing an α-methyl-2-ketothiazole as a metabolically stable serine trap.

    Mete, Antonio / Andrews, Glen / Bernstein, Mike / Connolly, Stephen / Hartopp, Paul / Jackson, Clive G / Lewis, Richard / Martin, Iain / Murray, David / Riley, Rob / Robinson, David H / Smith, Gill M / Wells, Edward / Withnall, W John

    Bioorganic & medicinal chemistry letters

    2011  Band 21, Heft 10, Seite(n) 3128–3133

    Abstract: We report the design of novel, potent cPLA(2)α inhibitors that possess an α-methyl-2-ketothiazole that acts as a serine-reactive moiety. We describe the optimization of the series for potency and metabolic stability towards ketone reduction. This was ... ...

    Abstract We report the design of novel, potent cPLA(2)α inhibitors that possess an α-methyl-2-ketothiazole that acts as a serine-reactive moiety. We describe the optimization of the series for potency and metabolic stability towards ketone reduction. This was achieved by attenuating the reactivity of the ketone using a combination of electronic and steric effects.
    Mesh-Begriff(e) Animals ; Drug Design ; Drug Stability ; Enzyme Activation/drug effects ; Enzyme Inhibitors/chemical synthesis ; Enzyme Inhibitors/chemistry ; Enzyme Inhibitors/pharmacology ; Group IV Phospholipases A2/antagonists & inhibitors ; HL-60 Cells ; Humans ; Inhibitory Concentration 50 ; Ketones/chemical synthesis ; Ketones/chemistry ; Ketones/pharmacology ; Magnetic Resonance Spectroscopy ; Molecular Structure ; Oxidation-Reduction ; Rats ; Serine/chemistry ; Thiazoles/chemical synthesis ; Thiazoles/chemistry ; Thiazoles/pharmacology
    Chemische Substanzen Enzyme Inhibitors ; Ketones ; Thiazoles ; Serine (452VLY9402) ; Group IV Phospholipases A2 (EC 3.1.1.4)
    Sprache Englisch
    Erscheinungsdatum 2011-05-15
    Erscheinungsland England
    Dokumenttyp Journal Article
    ZDB-ID 1063195-1
    ISSN 1464-3405 ; 0960-894X
    ISSN (online) 1464-3405
    ISSN 0960-894X
    DOI 10.1016/j.bmcl.2011.03.005
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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