Performance Assessment for the Validation of Wireless Communication Engines in an Innovative Wearable Monitoring Platform.

In today's health-monitoring applications, there is a growing demand for wireless and wearable acquisition platforms capable of simultaneously gathering multiple bio-signals from multiple body areas. These systems require well-structured software architectures, both to keep different wireless sensing nodes synchronized each other and to flush collected data towards an external gateway. This paper presents a quantitative analysis aimed at validating both the wireless synchronization task (implemented with a custom protocol) and the data transmission task (implemented with the BLE protocol) in a prototype wearable monitoring platform. We evaluated seven frequencies for exchanging synchronization packets (10 Hz, 20 Hz, 30 Hz, 40 Hz, 50 Hz, 60 Hz, 70 Hz) as well as two different BLE configurations (with and without the implementation of a dynamic adaptation of the BLE Connection Interval parameter). Additionally, we tested BLE data transmission performance in five different use case scenarios. As a result, we achieved the optimal performance in the synchronization task (1.18 ticks as median synchronization delay with a Min-Max range of 1.60 ticks and an Interquartile range (IQR) of 0.42 ticks) when exploiting a synchronization frequency of 40 Hz and the dynamic adaptation of the Connection Interval. Moreover, BLE data transmission proved to be significantly more efficient with shorter distances between the communicating nodes, growing worse by 30.5% beyond 8 m. In summary, this study suggests the best-performing network configurations to enhance the synchronization task of the prototype platform under analysis, as well as quantitative details on the best placement of data collectors.

Micro-CT-derived ventilation biomarkers for the longitudinal assessment of pathology and response to therapy in a mouse model of lung fibrosis.

Experimental in-vivo animal models are key tools to investigate the pathogenesis of lung disease and to discover new therapeutics. Histopathological and biochemical investigations of explanted lung tissue are currently considered the gold standard, but they provide space-localized information and are not amenable to longitudinal studies in individual animals. Here, we present an imaging procedure that uses micro-CT to extract morpho-functional indicators of lung pathology in a murine model of lung fibrosis. We quantified the decrease of lung ventilation and measured the antifibrotic effect of Nintedanib. A robust structure-function relationship was revealed by cumulative data correlating micro-CT with histomorphometric endpoints. The results highlight the potential of in-vivo micro-CT biomarkers as novel tools to monitor the progression of inflammatory and fibrotic lung disease and to shed light on the mechanism of action of candidate drugs. Our platform is also expected to streamline translation from preclinical studies to human patients.

Wearable Health Technology for Preoperative Risk Assessment in Elderly Patients: The WELCOME Study.

Preoperative identification of high-risk groups has been extensively studied to improve patients' outcomes. Wearable devices, which can track heart rate and physical activity data, are starting to be evaluated for patients' management. We hypothesized that commercial wearable devices (WD) may provide data associated with preoperative evaluation scales and tests, to identify patients with poor functional capacity at increased risk for complications. We conducted a prospective observational study including seventy-year-old patients undergoing two-hour surgeries under general anesthesia. Patients were asked to wear a WD for 7 days before surgery. WD data were compared to preoperatory clinical evaluation scales and with a 6-min walking test (6MWT). We enrolled 31 patients, with a mean age of 76.1 (SD ± 4.9) years. There were 11 (35%) ASA 3-4 patients. 6MWT results averaged 328.9 (SD ± 99.5) m. Daily steps and 𝑉𝑂2𝑚𝑎𝑥 as recorded using WD and were associated with 6MWT performance (R = 0.56, p = 0.001 and r = 0.58, p = 0.006, respectively) and clinical evaluation scales. This is the first study to evaluate WD as preoperative evaluation tools; we found a strong association between 6MWT, preoperative scales, and WD data. Low-cost wearable devices are a promising tool for the evaluation of cardiopulmonary fitness. Further research is needed to validate WD in this setting.

Non-invasive assessment of fatigue and recovery of inspiratory rib cage muscles during endurance test in healthy individuals.

INTRODUCTION: Fatigue is defined as loss of capacity to develop muscle force and/or velocity that is reversible at rest. We assessed non-invasively the fatigue and recovery of inspiratory rib cage muscles during two respiratory endurance tests in healthy individuals. METHODS: The sniff nasal inspiratory pressure (SNIP) was assessed before and after two respiratory endurance tests: normocapnic hyperpnea (NH) and inspiratory pressure threshold loading (IPTL). Contractile (maximum rate of pressure development and time to peak pressure) and relaxation parameters (maximum relaxation rate [MRR], time constant of pressure decay [τ], and half relaxation time) obtained from sniff curves and shortening velocity and mechanical power estimated using optoelectronic plethysmography were analyzed during SNIP maneuvers. Respiratory muscle activity (electromyography) and tissue oxygenation (near-infrared spectroscopy-NIRS) were obtained during endurance tests and SNIP maneuvers. Fatigue development of inspiratory rib cage muscles was assessed according to the slope of decay of median frequency. RESULTS: Peak pressure during SNIP decreased after both protocols (p <0.05). MRR, shortening velocity, and mechanical power decreased (p <0.05), whereas τ increased after IPTL (p <0.05). The median frequency of inspiratory rib cage muscles (i.e., sum of sternocleidomastoid, scalene, and parasternal) decreased linearly during IPTL and exponentially during NH, mainly due to the sternocleidomastoid. CONCLUSION: Fatigue development behaved differently between protocols and relaxation properties (MRR and τ), shortening velocity, and mechanical power changed only in the IPTL.

A Scoping Review on Wearable Devices for Environmental Monitoring and Their Application for Health and Wellness.

This scoping review is focused on wearable devices for environmental monitoring. First, the main pollutants are presented, followed by sensing technologies that are used for the parameters of interest. Selected examples of wearables and portables are divided into commercially available and research-level projects. While many commercial products are in fact portable, there is an increasing interest in using a completely wearable technology. This allows us to correlate the pollution level to other personal information (performed activity, position, and respiratory parameters) and thus to estimate personal exposure to given pollutants. The fact that there are no univocal indices to estimate outdoor or indoor air quality is also an open problem. Finally, applications of wearables for environmental monitoring are discussed. Combining environmental monitoring with other devices would permit better choices of where to perform sports activities, especially in highly polluted areas, and provide detailed information on the living conditions of individuals.

Respiratory physiology in pregnancy and assessment of pulmonary function.

A progressive chest wall adaptation occurs during pregnancy driven by the hormones and the expanding uterus. The effect of the former is more prevalent in the first weeks of pregnancy, while the latter is more evident in the last trimester. The combination of the hormonal-induced joint loosening together with the progressively enlarging uterus produces changes in the whole chest wall geometry, with the thoracic alterations being the most fundamental. The ribcage changes in size, but not in volume, secondary to an upward bucket handle shift centred in the xiphoidal process so that the lung is not restricted. A virtuous cycle of stretching and muscle conditioning seems to be established between the enlarging uterus, the diaphragm, and the abdominal muscles to prepare these muscles for the expulsive phase. From the respiratory point of view, the supine position seems to hinder the action of the abdominal muscles during forced expiration at the end of pregnancy.

Challenges and recommendations for wearable devices in digital health: Data quality, interoperability, health equity, fairness.

Wearable devices are increasingly present in the health context, as tools for biomedical research and clinical care. In this context, wearables are considered key tools for a more digital, personalised, preventive medicine. At the same time, wearables have also been associated with issues and risks, such as those connected to privacy and data sharing. Yet, discussions in the literature have mostly focused on either technical or ethical considerations, framing these as largely separate areas of discussion, and the contribution of wearables to the collection, development, application of biomedical knowledge has only partially been discussed. To fill in these gaps, in this article we provide an epistemic (knowledge-related) overview of the main functions of wearable technology for health: monitoring, screening, detection, and prediction. On this basis, we identify 4 areas of concern in the application of wearables for these functions: data quality, balanced estimations, health equity, and fairness. To move the field forward in an effective and beneficial direction, we present recommendations for the 4 areas: local standards of quality, interoperability, access, and representativity.

Non-Invasive Respiratory Assessment in Duchenne Muscular Dystrophy: From Clinical Research to Outcome Measures.

Ventilatory failure, due to the progressive wasting of respiratory muscles, is the main cause of death in patients with Duchenne muscular dystrophy (DMD). Reliable measures of lung function and respiratory muscle action are important to monitor disease progression, to identify early signs of ventilatory insufficiency and to plan individual respiratory management. Moreover, the current development of novel gene-modifying and pharmacological therapies highlighted the urgent need of respiratory outcomes to quantify the effects of these therapies. Pulmonary function tests represent the standard of care for lung function evaluation in DMD, but provide a global evaluation of respiratory involvement, which results from the interaction between different respiratory muscles. Currently, research studies have focused on finding novel outcome measures able to describe the behavior of individual respiratory muscles. This review overviews the measures currently identified in clinical research to follow the progressive respiratory decline in patients with DMD, from a global assessment to an individual structure-function muscle characterization. We aim to discuss their strengths and limitations, in relation to their current development and suitability as outcome measures for use in a clinical setting and as in upcoming drug trials in DMD.

Respiratory function assessment at the time of a new respiratory virus pandemic.

We must be aware that new respiratory virus pandemic can happen frequently. Standard lung function tests should keep their crucial role to assist the clinicians in the decision-making process, but they are at risk for the spread of infection because of the generated droplets. We used opto-electronic plethysmography to investigate the post-COVID-19 syndrome on 12 patients after ICU. We found normal ventilatory pattern at rest, a restrictive pattern located in the ribcage during vital capacity and surgical mask to significantly increase minute ventilation. The attention on unconventional respiratory function tests should be sponsored for the important information they can provide.

A Home Telemedicine System for Continuous Respiratory Monitoring.

This article presents a continuous home telemonitoring system for chronic respiratory patients using 5G connectivity developed in partnership with Vodafone as a part of the 5G Trial in Milan established by the Italian Ministry of Economic Development. The system features a wearable respiratory and activity monitor, an environmental sensor and a pulse oximeter sending the data through a 5G router to a Multi-Edge Computing server, incorporated in the Vodafone 5G infrastructure, where they are stored and accessible for visualization. In particular, activity, respiratory and environmental data are continuously streamed and collected. The solution has been tested on 18 healthy volunteers during non-supervised recordings lasting at least 48 hours. The combination of recognized activities and associated respiratory parameters provided statistically significant variations in breathing patterns between one activity and the other, thus giving more complete information to the clinicians than previously studied telemedicine systems based on spot-checks. In particular, statistically significant differences are found in tidal volume and minute ventilation between horizontal and vertical postures (p < 0.001) and between vertical postures and dynamic activities (p < 0.001); the respiratory rate shows statistically significant differences between horizontal and vertical postures (p < 0.001). Some environmental parameters have different mean values between day and night, such as carbon dioxide (p < 0.001). Trials on patients are needed to further study this telemedicine solution and make it commercially available in the future. The main further technical development suggested is the use of commercial 5G smartphones as routers, in order to make the system usable outside of home settings.

Longitudinal Assessment of Patients With Cystic Fibrosis Lung Disease With Multivolume Noncontrast MRI and Spirometry.

BACKGROUND: MRI has been suggested as a radiation-free imaging modality to investigate early structural alterations and regional functional impairment in cystic fibrosis (CF) lung disease. PURPOSE/HYPOTHESIS: To compare functional and morphological MRI changes over the course of the disease to changes in spirometry. STUDY TYPE: Longitudinal retrospective study. POPULATION: Twenty patients with CF lung disease (at baseline, age = 16.5 (13.3-20.6) years, forced expiratory volume in 1 second (as % of predicted [%pred]) FEV1 = 71 (59-87) %pred, forced expiratory flow at 25-75% of forced vital capacity FEF25-75 = 39 (25-63) %pred. FIELD STRENGTH/SEQUENCE: 1.5T / T2 -weighted HASTE; T2 -weighted TSE-PROPELLER; T2 -weighted bSSFP; T1 -weighted 3D GRE. ASSESSMENT: Nonenhanced chest MRI and spirometry were retrospectively collected over a 3-year period from the initial recruitment visit. Images acquired at end-inspiration and end-expiration were registered by software using the optical flow method to measure expiratory-inspiratory differences in MR signal-intensity (Δ1 H-MRI). Measures of CF functional impairment were defined from Δ1 H-MRI: Δ1 H-MRI median, Δ1 H-MRI quartile coefficient of variation (QCV), and percent low-signal-variation volume (LVV). MR images were also evaluated by three readers using a CF-specific scoring system. STATISTICAL TESTS: Spearman correlation analysis, Spearman rank correlation analysis, linear mixed-effect model analysis, intraclass correlation coefficient. RESULTS: Functional imaging parameters and total morphological score correlated with all spirometric measures, as did subscores of bronchial wall thickening/bronchiectasis, mucus plugging, and consolidation. Overall, the percent change of Δ1H-MRI median correlated with the percent change of FEV1 (ΔFEV1 , r = 0.41, P < 0.01) and the percent change of FEF25-75 (ΔFEF25-75%, r = 0.38, P < 0.01). The percent change of LVV correlated with ΔFEV1 (r = -0.47, P < 0.001) and ΔFEF25-75 (r = -0.50, P < 0.001). DATA CONCLUSION: These preliminary results suggest that nonenhanced multivolume MRI may provide a feasible tool to regionally map early pulmonary alterations for longitudinal evaluation of CF lung disease, without exposing the patients to ionizing radiation. LEVEL OF EVIDENCE: 3T TECHNICAL EFFICACY STAGE: 5.

Telemonitoring systems for respiratory patients: technological aspects.

This review introduces the reader to the available technologies in the field of telemonitoring, with focus on respiratory patients. In the materials and methods section, a general structure of telemonitoring systems for respiratory patients is presented and the sensors of interest are illustrated, i.e., respiratory monitors (wearable and non-wearable), activity trackers, pulse oximeters, environmental monitors and other sensors of physiological variables. Afterwards, the most common communication protocols are briefly introduced. In the results section, selected clinical studies that prove the significance of the presented parameters in chronic respiratory diseases are presented. This is followed by a discussion on the main current issues in telemedicine, in particular legal aspects, data privacy and benefits both in economic and health terms.

Assessment of Breathing Parameters Using an Inertial Measurement Unit (IMU)-Based System.

Breathing frequency (fB) is an important vital sign that-if appropriately monitored-may help to predict clinical adverse events. Inertial sensors open the door to the development of low-cost, wearable, and easy-to-use breathing-monitoring systems. The present paper proposes a new posture-independent processing algorithm for breath-by-breath extraction of breathing temporal parameters from chest-wall inclination change signals measured using inertial measurement units. An important step of the processing algorithm is dimension reduction (DR) that allows the extraction of a single respiratory signal starting from 4-component quaternion data. Three different DR methods are proposed and compared in terms of accuracy of breathing temporal parameter estimation, in a group of healthy subjects, considering different breathing patterns and different postures; optoelectronic plethysmography was used as reference system. In this study, we found that the method based on PCA-fusion of the four quaternion components provided the best fB estimation performance in terms of mean absolute errors (<2 breaths/min), correlation (r > 0.963) and Bland⁻Altman Analysis, outperforming the other two methods, based on the selection of a single quaternion component, identified on the basis of spectral analysis; particularly, in supine position, results provided by PCA-based method were even better than those obtained with the ideal quaternion component, determined a posteriori as the one providing the minimum estimation error. The proposed algorithm and system were able to successfully reconstruct the respiration-induced movement, and to accurately determine the respiratory rate in an automatic, position-independent manner.

Assessment of diaphragmatic thickness by ultrasonography in Duchenne muscular dystrophy (DMD) patients.

INTRODUCTION: In Duchenne muscular dystrophy (DMD) the assessment of diaphragmatic function is crucial because respiratory muscle weakness can cause respiratory failure. We aimed to noninvasively assess diaphragmatic function in DMD by measuring diaphragmatic thickness by ultrasonography, under the hypothesis that the progressive decrease of lung function is related to alterations of diaphragmatic thickness. METHODS: Forty-four DMD patients and thirteen healthy controls were enrolled and subdivided into three age groups. Diaphragmatic thickness was measured during quiet breathing, inspiratory capacity, maximal inspiratory pressure and expiratory pressure maneuvers. RESULTS: In DMD, absolute values of diaphragmatic thickness were significantly lower than in controls in the majority of the manoeuvers and diaphragmatic thickness significantly decreased with age at end-expiration, remaining constant at end-inspiration and during maximal inspiratory pressure maneuvers. Comparing to controls, absolute values of diaphragmatic thickness and diaphragmatic thickness variations were significantly lower (p<0.001), with the exception of quiet breathing and maximal expiratory pressure maneuvers in the youngest DMD. During maximal inspiratory pressure maneuver, variation of diaphragmatic thickness was not significantly different in the all groups, nevertheless maximal inspiratory pressure decreases with age. CONCLUSIONS: The diaphragm is prone to pseudo-hypertrophy in the youngest DMD, and to progressive atrophy in middle-age and oldest DMD. Diaphragm impairment could be expressed as a dissociation between muscle drive and muscle developed force. Ultrasonography could be used as a noninvasive method to assess progressive diaphragmatic weakness.

Assessment of pulmonary structure-function relationships in young children and adolescents with cystic fibrosis by multivolume proton-MRI and CT.

BACKGROUND: Lung disease is the most frequent cause of morbidity and mortality in patients with cystic fibrosis (CF), and there is a shortage of sensitive biomarkers able to regionally monitor disease progression and to assess early responses to therapy. PURPOSE: To determine the feasibility of noncontrast-enhanced multivolume MRI, which assesses intensity changes between expiratory and inspiratory breath-hold images, to detect and quantify regional ventilation abnormalities in CF lung disease, with a focus on the structure-function relationship. STUDY TYPE: Retrospective. POPULATION: Twenty-nine subjects, including healthy young children (n = 9, 7-37 months), healthy adolescents (n = 4, 14-22 years), young children with CF lung disease (n = 10, 7-47 months), and adolescents with CF lung disease (n = 6, 8-18 years) were studied. FIELD STRENGTH/SEQUENCE: 3D spoiled gradient-recalled sequence at 1.5T. ASSESSMENT: Subjects were scanned during breath-hold at functional residual capacity (FRC) and total lung capacity (TLC) through noncontrast-enhanced MRI and CT. Expiratory-inspiratory differences in MR signal-intensity (Δ1 H-MRI) and CT-density (ΔHU) were computed to estimate regional ventilation. MR and CT images were also evaluated using a CF-specific scoring system. STATISTICAL TESTS: Quadratic regression, Spearman's correlation, one-way analysis of variance (ANOVA). RESULTS: Δ1 H-MRI maps were sensitive to ventilation heterogeneity related to gravity dependence in healthy lung and to ventilation impairment in CF lung disease. A high correlation was found between MRI and CT ventilation maps (R2 = 0.79, P < 0.001). Globally, Δ1 H-MRI and ΔHU decrease with increasing morphological score (respectively, R2 = 0.56, P < 0.001 and R2 = 0.31, P < 0.001). Locally, Δ1 H-MRI was higher in healthy regions (median 15%) compared to regions with bronchiectasis, air trapping, consolidation, and to segments fed by airways with bronchial wall thickening (P < 0.001). DATA CONCLUSION: Multivolume noncontrast-enhanced MRI, as a nonionizing imaging modality that can be used on nearly any MRI scanner without specialized equipment or gaseous tracers, may be particularly valuable in CF care, providing a new imaging biomarker to detect early alterations in regional lung structure-function. LEVEL OF EVIDENCE: 3 Technical Efficacy: Stage 3 J. MAGN. RESON. IMAGING 2018;48:531-542.

An electrical impedance tomography (EIT) multi-electrode needle-probe device for local assessment of heterogeneous tissue impeditivity.

Electrical Impedance Tomography (EIT) is an image reconstruction technique applied in medicine for the electrical imaging of living tissues. In literature there is the evidence that a large resistivity variation related to the differences of the human tissues exists. As a result of this interest for the electrical characterization of the biological samples, recently the attention is also focused on the identification and characterization of the human tissue, by studying the homogeneity of its structure. An 8 electrodes needle-probe device has been developed with the intent of identifying the structural inhomogeneities under the surface layers. Ex-vivo impeditivity measurements, by placing the needle-probe in 5 different patterns of fat and lean porcine tissue, were performed, and impeditivity maps were obtained by EIDORS open source software for image reconstruction in electrical impedance. The values composing the maps have been analyzed, pointing out a good tissue discrimination, and the conformity with the real images. We conclude that this device is able to perform impeditivity maps matching to reality for position and orientation. In all the five patterns presented is possible to identify and replicate correctly the heterogeneous tissue under test. This new procedure can be helpful to the medical staff to completely characterize the biological sample, in different unclear situations.

A novel, low cost, wearable contact-based device for breathing frequency monitoring.

This paper presents a device for breathing frequency assessment over the long period, based on low cost, wearable inertial units. Performances of the device were evaluated in static conditions on 9 healthy subjects and the estimated parameters were compared to those obtained with an already validated method (Optoelectronic Plethysmography). We obtained good correlation values (R2> 0.88) and low percentage errors (<;5%) for all the time-based parameters extracted.

Respiratory muscle endurance training reduces the O2 cost of cycling and perceived exertion in obese adolescents.

In obesity, the increased O2 cost of breathing negatively affects the O2 cost of exercise and exercise tolerance. The purpose of the study was to determine whether, in obese adolescents, the addition of respiratory muscle endurance training (RMET) (isocapnic hyperpnea) to a standard body mass reduction program decreases the O2 cost of exercise and perceived exertion. Nine male obese adolescents [16.0 ± 1.4 yr (x ± SD), body mass 114.4 ± 22.3 kg] underwent 3 wk of RMET (5 days/week) in addition to a standard body mass reduction program. Eight age- and sex-matched obese adolescents underwent only the standard program (CTRL). Before and after interventions, patients performed on a cycle ergometer: incremental exercise; 12-min exercises at a constant work rate (CWR) of 65% and 120% at the gas exchange threshold (GET) determined before the intervention. Breath-by-breath pulmonary ventilation (V̇e) and O2 uptake (V̇o2), heart rate (HR), and ratings of perceived exertion for dyspnea/respiratory discomfort (RPER) and leg effort (RPEL) were determined. Body mass decreased (by ~3.0 kg) after both RMET (P = 0.003) and CTRL (P = 0.002). Peak V̇o2 was not affected by both interventions. Peak work rate was slightly, but significantly (P = 0.04), greater after RMET but not after CTRL. During CWR < GET, no changes were observed after both interventions. During CWR > GET, the O2 cost of cycling at the end of exercise (P = 0.02), the slope of V̇o2 vs. time (3-12 min) (P = 0.01), RPER (P = 0.01), and RPEL (P = 0.01) decreased following RMET, but not following CTRL. HR decreased after both RMET (P = 0.02) and CTRL (P = 0.03), whereas V̇e did not change. In obese adolescents RMET, superimposed on a standard body mass reduction program, lowered the O2 cost of cycling and perceived exertion during constant heavy-intensity exercise.