LIVIVO - Search results -

Search results

Result 1 - 10 of total 10

Search options

Article: 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
Language	English
Publishing date	2021-02-18
Publishing country	United States
Document type	Preprint
DOI	10.1101/2021.02.17.21249755
Database	MEDical Literature Analysis and Retrieval System OnLINE

Inter-library loan at ZB MED

Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

Details ▾

Article ; 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.
Keywords	covid19
Language	English
Publishing date	2021-02-18
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2021.02.17.21249755
Database	COVID19

Full text online

Inter-library loan at ZB MED

Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

Article ; 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 Volume 159, Issue 2, Page(s) 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 term(s)	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
Keywords	covid19
Language	English
Publishing date	2020-09-11
Publishing country	United States
Document type	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
Database	MEDical Literature Analysis and Retrieval System OnLINE

In stock of ZB MED Cologne/Königswinter

Ui III Zs.45: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG)
Zs.MO 349: Show issues

Order via subito

This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

Details ▾
- See ZB MED holdings
- Order with fees

Article ; 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 Volume 7, Issue 12, Page(s) 1001–1002

MeSH term(s)	Child ; Child Health Services/organization & administration ; Child, Preschool ; Developing Countries ; Humans ; Oximetry/economics ; Poverty ; Primary Health Care/organization & administration
Language	English
Publishing date	2019-10-17
Publishing country	England
Document type	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
Database	MEDical Literature Analysis and Retrieval System OnLINE

Full text online

Accessible to users with ZB MED library card

In stock of ZB MED Cologne/Königswinter

Zs.A 7041: Show issues

Location:
Je nach Verfügbarkeit (siehe Angabe bei Bestand)
bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
ab Jg. 2022: Lesesaal (EG)

Order via subito

Details ▾

Article: 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.
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #753798
Database	COVID19

Inter-library loan at ZB MED

Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

Details ▾

Article ; 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 Volume 54, Issue 7, Page(s) 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 term(s)	Child, Preschool ; Cross-Over Studies ; Humans ; Infant ; Infant, Newborn ; Oximetry/instrumentation ; Oxygen/blood
Chemical Substances	Oxygen (S88TT14065)
Language	English
Publishing date	2019-03-25
Publishing country	United States
Document type	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
Database	MEDical Literature Analysis and Retrieval System OnLINE

Full text online

Accessible to users with ZB MED library card

In stock of ZB MED Cologne/Königswinter

Zs.A 2143: Show issues

Location:
Je nach Verfügbarkeit (siehe Angabe bei Bestand)
bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
Jg. 1995 - 2021: Lesesall (1.OG)
ab Jg. 2022: Lesesaal (EG)

Order via subito

Details ▾

Article ; 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 Volume 99, Issue 4, Page(s) 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 term(s)	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
Chemical Substances	Oxyhemoglobins ; Oxygen (S88TT14065)
Language	English
Publishing date	2018-08-23
Publishing country	United States
Document type	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
Database	MEDical Literature Analysis and Retrieval System OnLINE

In stock of ZB MED Cologne/Königswinter

Ud II Zs.61: Show issues

Location:
Je nach Verfügbarkeit (siehe Angabe bei Bestand)
bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
ab Jg. 2022: Lesesaal (EG)

Order via subito

Details ▾
- See ZB MED holdings
- Order with fees

Article: 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.
Keywords	chemical reduction ; enzyme inhibitors ; ketones ; phospholipase A2 ; serine ; thiazoles
Language	English
Dates of publication	2011-0515
Size	p. 3128-3133.
Publishing place	Elsevier Ltd
Document type	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
Database	NAL-Catalogue (AGRICOLA)

Full text online

Accessible to users with ZB MED library card

In stock of ZB MED Cologne/Königswinter

Zs.A 3203: Show issues

Location:
Je nach Verfügbarkeit (siehe Angabe bei Bestand)
bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
Jg. 1995 - 2021: Lesesall (2.OG)
ab Jg. 2022: Lesesaal (EG)

Order via subito

Details ▾

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

Bioorganic & medicinal chemistry letters

2011 Volume 21, Issue 10, Page(s) 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 term(s)	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
Chemical Substances	Enzyme Inhibitors ; Ketones ; Thiazoles ; Serine (452VLY9402) ; Group IV Phospholipases A2 (EC 3.1.1.4)
Language	English
Publishing date	2011-05-15
Publishing country	England
Document type	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
Database	MEDical Literature Analysis and Retrieval System OnLINE

Full text online

Accessible to users with ZB MED library card

In stock of ZB MED Cologne/Königswinter

Zs.A 3203: Show issues

Location:
Je nach Verfügbarkeit (siehe Angabe bei Bestand)
bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
Jg. 1995 - 2021: Lesesall (2.OG)
ab Jg. 2022: Lesesaal (EG)

Order via subito

Details ▾

Article: 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

Volume v. 21,, Issue no. 1

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.
Keywords	enzyme inhibitors ; serine ; phospholipase A2 ; chemical reduction ; thiazoles ; ketones
Language	English
Document type	Article
ISSN	0960-894X
Database	AGRIS - International Information System for the Agricultural Sciences and Technology

Order via subito

Inter-library loan at ZB MED

Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

To top

More links

Kategorien

Inter-library loan at ZB MED

Full text online

Kategorien

Inter-library loan at ZB MED

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

Full text online

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

Kategorien

Inter-library loan at ZB MED

Full text online

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

Full text online

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

Full text online

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

More links

Kategorien

Order via subito

Inter-library loan at ZB MED