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All Subjects: Point of Care
Creators: Forzani, Erica

A Smart Home Medical Device for Accurate Metabolic Assessment

Description

Energy Expenditure (EE), a key diagnostic measurement for treatment of obesity, is measured via indirect calorimetry method through breath biomarkers of CO2 production and/or O2 consumption rates (VCO2 and/or VO2, respectively). Current technologies are limited due to prevailing designs requiring wearable facial accessories that present accuracy, precision, and usability concerns with regards to free living measurement. A novel medical device and smart home system, named Smart Pad, has been developed, with the capability of energy expenditure assessment via VCO2 measured from a room’s CO2 concentration. The system has 3 distinct capabilities: contactless EE measurement, air quality optimization via actuation of room ventilation, and efficiency optimization via ventilation actuation of only human-occupied environments. The Smart Pad shows accuracy of 90% for 14-19 minutes of resting measurement and accuracy of 90% for 4.8-7.0 minutes of exercise measurement after calibrating for air exchange rate (λ [hour-1]) using a reference method. Without reference instrument calibration, the Smart Pad system shows average accuracy of nearly 100% with correlations of Y=1.02X, R=0.761 for high resolution measurements and Y=1.06X, R=0.937 for averaged measurements over 50-60 minutes. In addition, the Smart Pad validation for contactless EE measurement has been performed in different environments, including a vehicle, medical office, a private office, and an ambulatory enclosure with rooms, ranging in volume from 3.1 m3 to 18.8m3. It was concluded that contactless EE measurements can be accurately performed in all tested scenarios with both low and high air exchange environments with λ ranging from 1.5 Hours-1 to 10.0 Hours -1. The system represents a new way to assess EE of individuals under free-living conditions in an unobstructive, passive, and accurate manner, and it is comparable or better in single breath gas measurement accuracy (with comparisons sourced from FDA data) than other medical devices (e.g. Vyntus CPXTM, MasterScreen CPXTM, Oxycon ProTM, and MedGemTM) which were 510(k) cleared by the FDA for prescription use in metabolic/cardiopulmonary diagnostics.

ContributorsSprowls, Mark (Author) / Forzani, Erica (Thesis advisor) / Destaillats, Hugo (Committee member) / Kulick, Doina (Committee member) / Nikkhah, Mehdi (Committee member) / Raupp, Gregory (Committee member) / Arizona State University (Publisher)

Created2021

Point of Care Detection of Iron Metabolism Parameters Through Colorimetric Sensing

Description

Abnormally low or high blood iron levels are common health conditions worldwide and can seriously affect an individual’s overall well-being. A low-cost point-of-care technology that measures blood iron markers with a goal of both preventing and treating iron-related disorders represents a significant advancement in medical care delivery systems. Methods: A novel assay equipped with an accurate, storable, and robust dry sensor strip, as well as a smartphone mount and (iPhone) app is used to measure total iron in human serum. The sensor strip has a vertical flow design and is based on an optimized chemical reaction. The reaction strips iron ions from blood-transport proteins, reduces Fe(III) to Fe(II), and chelates Fe(II) with ferene, with the change indicated by a blue color on the strip. The smartphone mount is robust and controls the light source of the color reading App, which is calibrated to obtain output iron concentration results. The real serum samples are then used to assess iron concentrations from the new assay and validated through intra-laboratory and inter-laboratory experiments. The intra-laboratory validation uses an optimized iron detection assay with multi-well plate spectrophotometry. The inter-laboratory validation method is performed in a commercial testing facility (LabCorp). Results: The novel assay with the dry sensor strip and smartphone mount, and App is seen to be sensitive to iron detection with a dynamic range of 50 - 300 µg/dL, sensitivity of 0.00049 µg/dL, coefficient of variation (CV) of 10.5%, and an estimated detection limit of ~15 µg/dL These analytical specifications are useful for predicting iron deficiency and overloads. The optimized reference method has a sensitivity of 0.00093 µg/dL and CV of 2.2%. The correlation of serum iron concentrations (N=20) between the optimized reference method and the novel assay renders a slope of 0.95, and a regression coefficient of 0.98, suggesting that the new assay is accurate. Lastly, a spectrophotometric study of the iron detection reaction kinetics is seen to reveal the reaction order for iron and chelating agent. Conclusion: The new assay is able to provide accurate results in intra- and inter- laboratory validations and has promising features of both mobility and low-cost.

ContributorsSerhan, Michael (Author) / Forzani, Erica (Thesis advisor) / Raupp, Gregory (Committee member) / Acharya, Abhinav (Committee member) / Hu, Tony (Committee member) / Smith, Barbara (Committee member) / Arizona State University (Publisher)

Created2020

Development of the SmartPad System for Energy Expenditure Measurement: A Novel Internet of Things (IoT) Diagnostic Medical Device for Obesity Treatment and Physical Fitness Assessment.

Description

Energy Expenditure (EE) (kcal/day) is a key parameter used to guide obesity treatment, and it is often measured from CO2 production, VCO2 (mL/min), and/or O2 consumption, VO2 (mL/min) through the principles of indirect calorimetry. Current EE measurement technologies are limited due to the requirement of wearable facial accessories, which can introduce errors as measurements are not taken under free-living conditions. A novel contactless system, the SmartPad, which measures EE via VCO2 from a room’s ambient CO2 concentration transients was evaluated. First, SmartPad accuracy was validated by comparing the SmartPad’s EE and VCO2 measurements with the measurements of a reference instrument, the MGC Ultima CPXTM, in a cross-sectional study consisting of 20 subjects. A high correlation between the SmartPad’s EE and VCO2 measurements and the MGC Ultima CPX’s EE and VCO2 measurements was found, and the Bland-Altman plots contained a low mean bias for EE and VCO2 measurements. Thus, the SmartPad was validated as being accurate for VCO2 and EE measurements. Next, resting EE (REE) and exercise VCO2 measurements were recorded using the SmartPad and the MGC Ultima CPXTM at different operating CO2 threshold ranges to investigate the influence of measurement duration on system accuracy in an effort to optimize the SmartPad system. The SmartPad displayed 90% accuracy (±1 SD) for 14–19 min of REE measurement and for 4.8–7.0 min of exercise, using a known room’s air exchange rate. Additionally, the SmartPad was validated by accurately measuring subjects’ REE across a wide range of body mass indexes (BMI = 18.8 to 31.4 kg/m^2) with REEs ranging from ~1200 to ~3000 kcal/day. Lastly, the SmartPad has been used to assess the physical fitness of subjects via the “Contactless Thermodynamic Efficiency Test” (CTET).

ContributorsVictor, Shaun (Author) / Forzani, Erica (Thesis director) / Wang, Shaopeng (Committee member) / Barrett, The Honors College (Contributor) / Watts College of Public Service & Community Solut (Contributor) / Harrington Bioengineering Program (Contributor)

Created2022-05