Riportiamo una breve ma significativa selezione di lavori clinici, pubblicati su riviste scientifiche internazionali, relativi a Trials clinici e Studi osservazionali, nei quali si è utilizzata la Soluzione VitalConnect.
Schema di lettura: estremi della Rivista scientifica, data, titolo, Autori, DOI, link per visualizzare la pubblicazione.
In rosso, un estratto delle salienze scientifiche evidenziate per ogni singola pubblicazione.
The Oxford University – UK, Sept 7, 2021.
A real-time wearable system for monitoring vital signs of COVID-19 patients in a hospital setting
Santos MD, Roman C, Pimentel MAF et all.
https://ora.ox.ac.uk/objects/uuid:97a0aaf8-cc78-4046-b120-c60982e68003
https://doi.org/10.3389/fdgth.2021.630273
Abstract: The challenges presented by the Coronavirus disease 2019 (COVID-19) pandemic to the National Health Service (NHS) in the United Kingdom (UK) led to a rapid adaptation of infection disease protocols in-hospital. In this paper we report on the optimisation of our wearable ambulatory monitoring system (AMS) to monitor COVID-19 patients on isolation wards. A wearable chest patch (VitalPatch®, VitalConnect, United States of America, USA) and finger-worn pulse oximeter (WristOx2® 3150, Nonin, USA) were used to estimate and transmit continuous Heart Rate (HR), Respiratory Rate (RR), and peripheral blood Oxygen Saturation (SpO2) data from ambulatory patients on these isolation wards to nurse bays remote from these patients, with a view to minimising the risk of infection for nursing staff. Our virtual High-Dependency Unit (vHDU) system used a secure web-based architecture and protocols (HTTPS and encrypted WebSockets) to transmit the vital-sign data in real time from wireless Android tablet devices, operating as patient data collection devices by the bedside in the isolation rooms, into the clinician dashboard interface available remotely via any modern web-browser. Fault-tolerant software strategies were used to reconnect the wearables automatically, avoiding the need for nurses to enter the isolation ward to re-set the patient monitoring equipment. The remote dashboard also displayed the vital-sign observations recorded by the nurses, using a separate electronic observation system, allowing them to review both sources of vital-sign data in one integrated chart. System usage was found to follow the trend of the number of local COVID-19 infections during the first wave of the pandemic in the UK (March to June 2020), with almost half of the patients on the isolation ward monitored with wearables during the peak of hospital admissions in the local area. Patients were monitored for a median of 31.5 [8.8, 75.4] hours, representing 88.1 [62.5, 94.5]% of the median time they were registered in the system. This indicates the system was being used in the isolation ward during this period. An updated version of the system has now also been used throughout the second and third waves of the pandemic in the UK.
Circulation: Heart Failure. 2020;13.
Continuous Wearable Monitoring Analytics Predict Heart Failure Hospitalization
The LINK-HF Multicenter Study
Josef Stehlik, Carsten Schmalfuss, Biykem Bozkurt, Jose Nativi-Nicolau, Peter Wohlfahrt et al.
https://doi.org/10.1161/CIRCHEARTFAILURE.119.006513
https://pubmed.ncbi.nlm.nih.gov/32093506/
Background: Implantable cardiac sensors have shown promise in reducing rehospitalization for heart failure (HF), but the efficacy of noninvasive approaches has not been determined. The objective of this study was to determine the accuracy of noninvasive remote monitoring in predicting HF rehospitalization.
Methods: The LINK-HF study (Multisensor Non-invasive Remote Monitoring for Prediction of Heart Failure Exacerbation) examined the performance of a personalized analytical platform using continuous data streams to predict rehospitalization after HF admission. Study subjects were monitored for up to 3 months using a disposable multisensor patch placed on the chest that recorded physiological data. Data were uploaded continuously via smartphone to a cloud analytics platform. Machine learning was used to design a prognostic algorithm to detect HF exacerbation. Clinical events were formally adjudicated.
Results: One hundred subjects aged 68.4±10.2 years (98% male) were enrolled. After discharge, the analytical platform derived a personalized baseline model of expected physiological values. Differences between baseline model estimated vital signs and actual monitored values were used to trigger a clinical alert. There were 35 unplanned nontrauma hospitalization events, including 24 worsening HF events. The platform was able to detect precursors of hospitalization for HF exacerbation with 76% to 88% sensitivity and 85% specificity. Median time between initial alert and readmission was 6.5 (4.2-13.7) days.
Conclusions: Multivariate physiological telemetry from a wearable sensor can provide accurate early detection of impending rehospitalization with a predictive accuracy comparable to implanted devices. The clinical efficacy and generalizability of this low-cost noninvasive approach to rehospitalization mitigation should be further tested. Registration: URL: https://www.clinicaltrials.gov. Unique Identifier: NCT03037710.
JMIR Mhealth Uhealth 2020 Dec 16;8(12):e20214. doi: 10.2196/20214.
Wearability Testing of Ambulatory Vital Sign Monitoring Devices: Prospective Observational Cohort Study
Carlos Areia, Louise Young, Sarah Vollam, Jody Ede, Mauro Santos, Lionel Tarassenko, Peter Watkinson.
PMID: 33325827– DOI: 10.2196/20214
https://pubmed.ncbi.nlm.nih.gov/33325827/
…” the VitalPatch was superior in the Attachment section (P=.04) with a median (IQR) score of 3.00 (1.00). General pain and discomfort scores and total percentage of time worn are also reflective of this.
Conclusions: Our results suggest that adult participants prefer to wear wrist-worn pulse oximeters without a probe compressing the fingertip and they prefer to wear a smaller chest patch. A compromise between wearability, reliability, and accuracy should be made for successful and practical integration of AMSs within the hospital environment”.
Annu Int Conf IEEE Eng Med Biol Soc . 2020 Jul;2020:4652-4655.
doi: 10.1109/EMBC44109.2020.9175579.
Feasibility of Continuous Monitoring of Core Body Temperature Using Chest-worn Patch Sensor
Paurakh L Rajbhandary, Gabriel Nallathambi
PMID: 33019031– DOI: 10.1109/EMBC44109.2020.9175579
https://pubmed.ncbi.nlm.nih.gov/33019031/
“With rapid advancement in wearable biosensor technology, systems capable of real time, continuous and ambulatory monitoring of vital signs are increasingly emerging and their use can potentially help improve patient outcome. Monitoring continuous body temperature offers insights into its trend, allows early detection of fever and is critical in several diseases and clinical conditions including septicemia, infectious disease and others. There is a complex interaction between physiological and ambient parameters including heart rate, respiratory rate, muscle rigors and shivers, diaphoresis, local humidity, clothing, body, skin and ambient temperatures among others. This article presents feasibility analysis of a wireless biosensor patch device called as VitalPatch in capturing this physio-ambient-thermodynamic interaction to determine core body temperature, and details comparative performance assessments using oral thermometer and ingestible pill as reference devices. Based on a study on a cohort of 30 subjects with reference oral temperature, the proposed method showed a bias of 0.1 ± 0.37 °C, mean absolute error (MAE) of 0.29 ± 0.25 °C. Another cohort of 22 subjects with continuous core body temperature pill as reference showed a bias of 0.16 ± 0.38 °C and MAE of 0.42 ± 0.22 °C.Clinical Relevance- Non-invasive, continuous and real time body temperature monitoring can lead to earlier fever detection and provides remote patient monitoring that can result in improved patient and clinical outcome”.
Diabetes Care. 2019 Apr;42(4):689-692.doi: 10.2337/dc18-1843.
Early Detection of Hypoglycemia in Type 1 Diabetes Using Heart Rate Variability Measured by a Wearable Device
Marleen Olde Bekkink, Mats Koeneman, Bastiaan E de Galan, Sebastian J Bredie
PMID: 30877089 – DOI: 10.2337/dc18-1843
https://pubmed.ncbi.nlm.nih.gov/30877089/
“Conclusions: Hypoglycemia causes early changes in HRV that can be detected by a wearable device. Measuring real-time HRV seems promising for early hypoglycemia detection”.
Digit Biomark. 2018 Jan 10;1(2):118-125. doi: 10.1159/000485469. eCollection Oct-Dec 2017.
A Pilot Study Evaluating the Physiological Parameters of Performance-Induced Stress in Undergraduate Music Students
Esther M van Fenema, Pim Gal, Maxime V van de Griend, Gabriel E Jacobs, Adam F Cohen
PMID: 32095753 – PMCID: PMC7015379 – DOI: 10.1159/000485469
https://pubmed.ncbi.nlm.nih.gov/32095753/
“In conclusion, the wearable biosensor patch proved to be an adequate tool to assess physiological stress parameters on stage”.
J Cardiovasc Electrophysiol. 2020 Nov;31(11):2803-2811. doi: 10.1111/jce.14727. Epub 2020 Sep 4.
Inpatient cardiac monitoring using a patch-based mobile cardiac telemetry system during the COVID-19 pandemic
Eric D Braunstein, Olga Reynbakh, Andrew Krumerman, Luigi Di Biase, Kevin J Ferrick
PMID: 32852868 – PMCID: PMC7461402 – DOI: 10.1111/jce.14727
https://pubmed.ncbi.nlm.nih.gov/32852868/
“Introduction: Coronavirus disease 2019 (COVID-19) is a worldwide pandemic, and cardiovascular complications and arrhythmias in these patients are common. Cardiac monitoring is recommended for at risk patients; however, the availability of telemetry capable hospital beds is limited. We sought to evaluate a patch-based mobile telemetry system for inpatient cardiac monitoring during the pandemic.
Results: Eighty-two patients underwent mobile telemetry device placement, of which 31 (37.8%) met the primary outcome, which consisted of 24 (29.3%) with new arrhythmias detected and 18 (22.2%) with management changes. Twenty-one patients (25.6%) died during the study, but none from primary arrhythmias. In analyses, age and heart failure were associated with the primary outcome. Monitoring occurred for an average of 5.3 ± 3.4 days, with 432 total patient-days of monitoring performed; of these, QT-interval measurements were feasible in 400 (92.6%).
Conclusion: A mobile telemetry system was successfully implemented for inpatient use during the COVID-19 pandemic and was shown to be useful to inform patient management, detect occult arrhythmias, and monitor the QT-interval. Patients with advanced age and structural heart disease may be more likely to benefit from this system”.
JMIR Hum Factors. 2019 Dec 2;6(4):e15103. doi: 10.2196/15103.
Remote Patient Monitoring in Adults Receiving Transfusion or Infusion for Hematological Disorders Using the VitalPatch and accelerateIQ Monitoring System: Quantitative Feasibility Study
Rik Paulus Bernardus Tonino, Karen Larimer, Okke Eissen, Martin Roelof Schipperus
PMID: 31789596 – PMCID: PMC6915430 – DOI: 10.2196/15103
https://pubmed.ncbi.nlm.nih.gov/31789596/
“Conclusions: Generally, the VitalPatch was well tolerated and shown to be an attractive device because of its wearability and low impact on daily activities in patients, therefore making it suitable for implementation in future studies”.
JMIR Perioper Med. 2020 Dec 4;3(2):e21705.doi: 10.2196/21705.
Wireless Remote Home Monitoring of Vital Signs in Patients Discharged Early After Esophagectomy: Observational Feasibility Study
Martine J M Breteler, Lieke Numan, Jelle P Ruurda, Richard van Hillegersberg, Sylvia van der Horst, Daan A J Dohmen, Mathilde C van Rossum, Cor J Kalkman
PMID: 33393923 – PMCID: PMC7728408 – DOI: 10.2196/21705
https://pubmed.ncbi.nlm.nih.gov/33393923/
“Methods: In an observational feasibility study, vital signs of patients were monitored with a wearable patch sensor (VitalPatch, VitalConnect Inc) during the first 7 days at home after esophagectomy and discharge from hospital. Vital signs trends were shared with the surgical team once a day, and they were asked to check the patient’s condition by phone each morning
Conclusions: Remote monitoring of vital signs combined with telephone support from the surgical team was feasible and well perceived by all patients. Future studies need to evaluate the impact of home monitoring on patient outcome as well as the cost-effectiveness of this new approach”.
Can J Cardiol. 2018 Aug;34(8):1083-1087. doi: 10.1016/j.cjca.2018.05.003. Epub 2018 May 9.
The Emerging Role of Wearable Technologies in Detection of Arrhythmia
Christopher C Cheung, Andrew D Krahn, Jason G Andrade
PMID: 30049358 – DOI: 10.1016/j.cjca.2018.05.003
https://pubmed.ncbi.nlm.nih.gov/30049358/
…”Wearables have the potential to become truly disruptive in our health care sector, with large segments of the population soon to have readily available health data that the physician must interpret”.
J Med Internet Res. 2018 Dec 11;20(12):e10802. doi: 10.2196/10802.
Continuous Versus Intermittent Vital Signs Monitoring Using a Wearable, Wireless Patch in Patients Admitted to Surgical Wards: Pilot Cluster Randomized Controlled Trial
Candice Downey, Rebecca Randell, Julia Brown, David G Jayne
PMID: 30538086 – PMCID: PMC6305881 – DOI: 10.2196/10802
https://pubmed.ncbi.nlm.nih.gov/30538086/
“Background: Vital signs monitoring is a universal tool for the detection of postoperative complications; however, unwell patients can be missed between traditional observation rounds. New remote monitoring technologies promise to convey the benefits of continuous monitoring to patients in general wards.
Methods: We performed a prospective, cluster-randomized, parallel-group, unblinded, controlled pilot study
Conclusions: Remote continuous vital signs monitoring on surgical wards is practical and acceptable to patients”.
J Innov Card Rhythm Manag. 2019 Sep 15;10(9):3803-3808. doi: 10.19102/icrm.2019.100901. eCollection 2019 Sep.
Feasibility and Usability of Patch-based Continuous Cardiac Rhythm Monitoring in Comparison with Traditional Telemetry in Noncritically Ill Hospitalized Patients
Ram Amuthan , Alicia Burkle , Steven Mould , John Tote , Molly Loy , Desiree Kirkwood , Josalyn Meyer , Shannon Pengel , Aaron C Hamilton , Daniel J Cantillon.
PMID: 32477749 – PMCID: PMC7252747 – DOI: 10.19102/icrm.2019.100901
https://pubmed.ncbi.nlm.nih.gov/32477749/
…”Research on traditional cardiac telemetry demonstrates that excessive alarms are related to lead failures and noise-related interruptions. Patch-based continuous cardiac rhythm monitoring (CCRM) has emerged in outpatient ambulatory monitoring situations as a means to improve recording fidelity. In this study, patients hospitalized but not in the intensive care unit were simultaneously monitored via telemetry in parallel with the use of the Vital Signs Patch™ (VSP) CCRM system (LifeWatch Services, Rosemont, IL, USA), applying standardized monitoring and notifications provided by an off-site central monitoring unit (CMU). Among 11 patients (55% male; age: 66.8 ± 12.5 years), there were 42 CMU detections and 98 VSP detections. The VSP device was successfully applied by nursing with connectivity established in all 11 patients (100%). There were no VSP device-related adverse events or skin eruptions during the study. The CMU agreed with 59 (60%) of 98 VSP detections. Among those detections marked by disagreement 30 (77%) of 39 VSP detections were related to clinically meaningful arrhythmias (atrial: n = 9; ventricular: n = 7; brady-: n = 14) undetected by VSP due to noise. In two patients (18%), there were four clinically meaningful atrial fibrillation detections not recorded by the CMU. In conclusion, patch-based CCRM requires further development and review to replace traditional cardiac telemetry monitoring but could evolve into an appropriate method to detect clinically meaningful events missed by traditional methods if noise issues can be mitigated”.
2018 40th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC). NSPEC Accession Number: 18226715
Fully Disposable Wireless Patch Sensor for Continuous Remote Patient Monitoring
Nandakumar Selvaraj; Gabriel Nallathambi; Rod Moghadam; Arshan Aga
DOI: 10.1109/EMBC.2018.8512569
https://pubmed.ncbi.nlm.nih.gov/30440706/
“Continuous remote monitoring with convenient wireless sensors is attractive for early detection of patient deterioration, preventing adverse events and leading to better patient care. This article presents an innovative sensor design of VitalPatch, a fully disposable wireless biosensor, for remote continuous monitoring, and details the performance assessments from bench testing and laboratory validation in 57 subjects. The bench testing results reveal that VitalPatch’s QRS detection had a positive predictive value of $> 99$% from testing with ECG databases. The accuracies of HR, BR and skin temp (in mean absolute error, MAE) from bench testing were $< 5$ bpm, $< 1$ brpm, $< 1 ^{ \circ}C$ respectively. The laboratory testing in 57 subjects revealed the accuracy of HR and BR to be $2.2 \pm 1.5$ bpm and $1.7 \pm 0.7$ brpm respectively for stationary periods. The absolute percent error in detecting steps was $4.7 \pm 4.6$%, and the accuracy in detecting posture was $96.4 \pm 3.1$%. Meanwhile, the specificity and sensitivity of fall detection $( \mathrm {n}=20)$ was found to be 100% and 93.8%, respectively. In conclusion, VitalPatch biosensor demonstrated clinically acceptable accuracies for its vital signs and actigraphy metrics applicable for continuous unobtrusive patient monitoring”.
PLOS. October 25, 2018.
Validation of a wireless patch sensor to monitor mobility tested in both an experimental and a hospital setup: A cross-sectional study
Niek Koenders, Joost P. H. Seeger, Teun van der Giessen,, Ties J. van den Hurk,, Indy G. M. Smits, Anne M. Tankink, Maria W. G. Nijhuis – van der Sanden, Thomas J. Hoogeboom
https://doi.org/10.1371/journal.pone.0206304
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0206304
“Purpose. To assess the concurrent validity of a wireless patch sensor to monitor time lying, sitting/standing, and walking in an experimental and a hospital setup.
Results. Thirty-one males were included. Significant mean differences were found between HealthPatch data and reference values for sitting/standing (mean 14.4 minutes, reference: 12.0 minutes, p<0.01) and walking (mean 6.4 minutes, reference: 9.0 minutes, p<0.01) in the experimental setup. Good correlations were found between the HealthPatch data and video data for lying (ICC: 0.824) and sitting/standing (ICC: 0.715) in the hospital setup. Posture detection accuracies of the HealthPatch were significantly higher for lying and sitting/standing in the experimental setup”.
Digit Biomark 2020;4:45–59
Real-Life Multimarker Monitoring in Patients with Heart Failure: Continuous Remote Monitoring of Mobility and Patient-Reported Outcomes as Digital End Points in Future Heart-Failure Trials
Kramer F. Butler J.· Shah S.J.· Jung C.· Nodari S.· et al.
https://doi.org/10.1159/000507696
https://pubmed.ncbi.nlm.nih.gov/33083685/
“Aims: Heart failure (HF) affects approximately 26 million people worldwide. With an aging global population, innovative approaches to HF evaluation and management are needed to cope with the worsening HF epidemic. The aim of the Real-Life Multimarker Monitoring in Patients with Heart Failure (REALIsM-HF) study (NCT03507439) is to evaluate a composite instrument comprising remote, real-time, activity-monitoring devices combined with daily electronic patient-reported outcome (ePRO) items in patients who have been hospitalized for HF and are undergoing standard HF assessment (e.g., 6-min walking distance [6MWD], blood biomarkers, Kansas City Cardiomyopathy Questionnaire [KCCQ], and echocardiography).
Methods: REALIsM-HF is an ongoing, 12-week, observational study enrolling 80-100 patients aged ≥45 years with HF with preserved ejection fraction (HFpEF; EF ≥45%) or reduced EF (HFrEF; EF ≤35%). Statistical analyses will include examining the association between data from wearables (the AVIVO© mobile patient management patch or VitalPatch© biosensor, and the DynaPort MoveMonitor©), daily ePROs, and conventional HF metrics (e.g., serum/plasma biomarkers, 6MWD, KCCQ, and echocardiographic parameters). The feasibility of and patient compliance with at-home devices will be documented, and the data captured for the purpose of establishing reference values in patients with HFpEF or HFrEF will be summarized.
Conclusions: The REALIsM-HF study is to evaluate the longitudinal daily activity profiles of patients with HF and correlate these with changes in serum/plasma biomarker profiles, symptoms, quality of life, and cardiac function and morphology to inform the use of wearable activity monitors for developing novel therapies and managing patients”.
BMJ Open. 2018 Feb 27;8(2):e020162. doi: 10.1136/bmjopen-2017-020162.
Reliability of wireless monitoring using a wearable patch sensor in high-risk surgical patients at a step-down unit in the Netherlands: a clinical validation study
Martine J M Breteler MSc, Erik Huizinga, Kim van Loon, Luke P H Leenen, Daan A J Dohmen, Cor J Kalkman, Taco J Blokhuis
PMID: 29487076 – PMCID: PMC5855309 – DOI: 10.1136/bmjopen-2017-020162
https://bmjopen.bmj.com/content/8/2/e020162
Background and objectives Intermittent vital signs measurements are the current standard on hospital wards, typically recorded once every 8 hours. Early signs of deterioration may therefore be missed. Recent innovations have resulted in ‘wearable’ sensors, which may capture patient deterioration at an earlier stage. The objective of this study was to determine whether a wireless ‘patch’ sensor is able to reliably measure respiratory and heart rate continuously in high-risk surgical patients. The secondary objective was to explore the potential of the wireless sensor to serve as a safety monitor.
Setting University teaching hospital, single centre.
Participants Twenty-five postoperative surgical patients admitted to a step-down unit.
Conclusions. Remote monitoring has the potential to contribute to early recognition of physiological decline in high-risk patients. Future studies should focus on the ability to detect patient deterioration on low care environments and at home after discharge.
Neurology. 2019 Sep 3;93(10):450-458. doi: 10.1212/WNL.0000000000008077.
Cardiac electrical instability in newly diagnosed/chronic epilepsy tracked by Holter and ECG patch.
Trudy D Pang , Bruce D Nearing , Kaarkuzhali Babu Krishnamurthy , Bryan Olin , Steven C Schachter , Richard L Verrier
PMID: 31477610 – DOI: 10.1212/WNL.0000000000008077
https://n.neurology.org/content/93/10/450
…“We hypothesized that cardiac electrical instability and abnormal autonomic tone result from cumulative cardiac injury sustained in recurrent seizures. We tested this hypothesis by comparing T-wave alternans (TWA) and heart rate variability (HRV), both established markers of sudden cardiac death (SCD) risk, in patients with chronic as compared to newly diagnosed epilepsy… TWA levels in chronic epilepsy were significantly higher than in newly diagnosed epilepsy (62 ± 5.4 vs 35 ± 1.3 μV, p < 0.002…it appears that chronic epilepsy, the common use of sodium channel antagonists, or other factors are associated with higher TWA levels and simultaneously with lower rMSSD HRV, which is suggestive of autonomic dysfunction or higher sympathetic tone. The ECG patch monitor used has equivalent accuracy to Holter monitoring for TWA and HRV and permits longer-term ECG sampling…”.
“The current study assessed the performance of HealthPatchTM sensor over its 3-day wear cycle, quantified the user compliance, user’s feedback on wearability and usability over 3603 days among 76 senior participants. The results demonstrated high performance of vital sign measurements, high compliance for sensor use, and encouraging positive feedback on wearability and usability of unobtrusive patch sensors for continuous home use.
The patch sensor can send notifications to self, family, assisted living facilities regarding abnormal changes in vital signs, long-term trending of vital signs, unusual activity/no activity, and falls. The health-related information on individuals would be valuable for effective patient/elderly care management in health care as well as home settings. The wireless patch biosensor solution could reduce the direct and indirect medical costs and make the routine consultations very effective providing the principle care physician by providing objective physiological trends collected over the days before the office visit. The current results particularly on the wearability and usability are very significant because the study assessed the worse case scenario of suitability of VitalConnect Platform for home use on a challenging cohort of elderly participants who are less likely to be comfortable with latest technology and more likely to have sensitive skin. This study indicates that VitalConnect Platform with the HealthPatchTM sensor is highly efficient and convenient for long-term monitoring at home setting”.
Annu Int Conf IEEE Eng Med Biol Soc . 2013;2013:6115-8. doi: 10.1109/EMBC.2013.6610948.
Wireless patch sensor for remote monitoring of heart rate, respiration, activity, and falls
Alexander M Chan, Nandakumar Selvaraj, Nima Ferdosi
PMID: 24111135 – DOI: 10.1109/EMBC.2013.6610948
https://pubmed.ncbi.nlm.nih.gov/24111135/
…”Unobtrusive continuous monitoring of important vital signs and activity metrics has the potential to provide remote health monitoring, at-home screening, and rapid notification of critical events such as heart attacks, falls, or respiratory distress. This paper contains validation results of a wireless Bluetooth Low Energy (BLE) patch sensor consisting of two electrocardiography (ECG) electrodes, a microcontroller, a tri-axial accelerometer, and a BLE transceiver. The sensor measures heart rate, heart rate variability (HRV), respiratory rate, posture, steps, and falls and was evaluated on a total of 25 adult participants who performed breathing exercises, activities of daily living (ADLs), various stretches, stationary cycling, walking/running, and simulated falls. Compared to reference devices, the heart rate measurement had a mean absolute error (MAE) of less than 2 bpm, time-domain HRV measurements had an RMS error of less than 15 ms, respiratory rate had an MAE of 1.1 breaths per minute during metronome breathing, posture detection had an accuracy of over 95% in two of the three patch locations, steps were counted with an absolute error of less than 5%, and falls were detected with a sensitivity of 95.2% and specificity of 100%”.
Injury. 2020 May;51 Suppl 2:S97-S105. doi: 10.1016/j.injury.2019.11.018. Epub 2019 Nov 17.
Are current wireless monitoring systems capable of detecting adverse events in high-risk surgical patients? A descriptive study
Martine J M Breteler , Eline KleinJan , Lieke Numan , Jelle P Ruurda , Richard Van Hillegersberg , Luke P H Leenen , Mathilde Hermans , Cor J Kalkman , Taco J Blokhuis
PMID: 31761422 – DOI: 10.1016/j.injury.2019.11.018
https://europepmc.org/article/med/31761422
…”Adverse events are common in high-risk surgical patients, but early detection is difficult. Recent innovations have resulted in wireless and ‘wearable’ sensors, which may capture patient deterioration at an early stage, but little is known regarding their ability to timely detect events. The objective of this study is to describe the ability of currently available wireless sensors to detect adverse events in high-risk patients….A descriptive analysis was performed of all vital signs trend data obtained during an observational comparison study of wearable sensors for vital signs monitoring in high-risk surgical patients during the initial days of recovery at a surgical step-down unit (SDU) and subsequent traumatology or surgical oncology ward. Heart rate (HR), respiratory rate (RR) and oxygen saturation (SpO2) were continuously recorded. Vital sign trend patterns of patients that developed adverse events were described and compared to vital sign recordings of patients without occurrence of adverse events. Two wearable patch sensors were used (SensiumVitals and HealthPatch), a bed-based mattress sensor (EarlySense) and a patient-worn monitor (Masimo Radius-7).
Results: Twenty adverse events occurred in 11 of the 31 patients included. Atrial fibrillation (AF) was most common (20%). The onset of AF was recognizable as a sudden increase in HR in all recordings, and all patients with new-onset AF after esophagectomy developed other postoperative complications. Patients who developed respiratory insufficiency showed an increase in RR and a decrease in SpO2, but an increase in HR was not always visible. In patients without adverse events, temporary periods of high HR and RR are observed as well, but these were transient and less frequent.
Conclusions: Current systems for remote wireless patient monitoring on the ward are capable of detecting abnormalities in vital sign patterns in patients who develop adverse events. Remote patient monitoring may have potential to improve patient safety by generating early warnings for deterioration to nursing staff”.
Stud Health Technol Inform. 2018;249:189-193.
Medical Device Integrated Vital Signs Monitoring Application with Real-Time Clinical Decision Support
Aasia Moqeem , Mirza Baig , Hamid Gholamhosseini , Farhaan Mirza , Maria Lindén
PMID: 29866980
https://pubmed.ncbi.nlm.nih.gov/29866980/
This research involves the design and development of a novel Android smartphone application for real-time vital signs monitoring and decision support. The proposed application integrates market available, wireless and Bluetooth connected medical devices for collecting vital signs. The medical device data collected by the app includes heart rate, oxygen saturation and electrocardiograph (ECG). The collected data is streamed/displayed on the smartphone in real-time. This application was designed by adopting six screens approach (6S) mobile development framework and focused on user-centered approach and considered clinicians-as-a-user. The clinical engagement, consultations, feedback and usability of the application in the everyday practices were considered critical from the initial phase of the design and development. Furthermore, the proposed application is capable to deliver rich clinical decision support in real-time using the integrated medical device data”.
These solutions are changing hospital care as we know it. Nersi Nazari, Ph.D. and CEO of VitalConnect, offers a vision of the future: “Think of a hospital not as a building housing patients within its walls. Instead think of it as a center of care that monitors patients wherever they may be.”
The Vista Solution works with three core use cases:
- Current patients inside a hospital.Patients can be fitted with the VitalPatch biosensor. Their data flows continuously to the platform. Instead of constantly checking on patients in room after room, waking them up from sleep to gather vital statistics, nurses can monitor those stats via the platform. Notifications can indicate patients who need nurse attendance, keeping the nurses focused on their most important task: providing quality care.
Nazari notes that nurses are great advocates for this system. “Nurses are trained to provide patient care,” he said. “They’d rather spend time doing that than disturbing patients’ sleep to take their vitals. This makes their job easier and allows them to focus on patients that need the most attention.”
- Patients recently released from the hospital. The first 30 days after patient release are the most critical — this is the period when patients have the highest probability of readmission. For some patients, 30 days of monitoring using the biosensor may be the answer to improve care and reduce the chance of readmission. By continuously monitoring vital statistics, healthcare providers are alerted to potential health issues in real time. They can respond by having the caregiver visit the patient or by remotely updating the prescribed care plan to prevent the issue from becoming more serious.
- The “admit to home” option for care.Some patients arrive at a hospital feeling ill, but not enough so to be admitted. Instead, they can be fitted with the VitalPatch and stay home while health providers monitor data.
Brigham and Women’s Hospital in Massachusetts served as the trial site for this innovative biosensor use case. Early phases of the trial demonstrated a 52 percent reduction in hospitalization costs as well as improved patient outcomes. Those improvements included happier patients, better quality of life and increased safety.
http://telecareaware.com/tag/vitalconnect/
“MediBioSense and Blue Cedar take a new approach to secure medical wearable data (UK/US)
January 23, 2018 | by Donna Cusano | No Comments
Doncaster UK-based MediBioSense Ltd. has partnered with San Francisco-based Blue Cedar to protect their VitalPatch app on smartphones and tablets. MediBioSense uses VitalPatch in their MBS HealthStream system marketed in the UK in acute care and long-term care setting. Blue Cedar is securing the app through their patented code-injected technology which protects the VitalPatch-collected data from the app to the provider database. The system with Blue Cedar’s security is available directly from MediBioSense.
VitalPatch is a single-use adhesive biosensor patch applied to the patient’s chest (see left above). It monitors eight vital signs and activity signs: heart rate, respiration, ECG, heart rate variability, temperature, body posture including fall detection/severity, and steps as an indicator of activity. MediBioSense contracted with the US-based developer, VitalConnect, to sell the system in the UK. VitalPatch is US FDA-cleared (Class II) and CE Marked for the EU.
One impetus, according to the release (PDF), is the GDPR (General Data Protection Regulation), the pan-European/UK data-protection law slated to take effect in May. This not only applies to European Union citizens’ personal data but also requires reports on how organizations safeguard that data.
Blue Cedar, which this Editor has previously profiled [TTA 3 May 17], has developed code-injection technology that secures data from the app to the provider location on their servers or in the cloud. It secures the app without the device being managed. Devices have their own vulnerabilities when it comes to apps even when secured, as 84 percent of cyberattacks happen at the application layer (SAP). Blue Cedar’s security also enables tap-and-go from an icon versus multiple security entries, thus quick downloading from app stores or websites. For companies, the secured app provides granular analytic reports about users, app usage, devices, and operating systems which are useful for GDPR requirements.
Blue Cedar’s latest release of app security is Enforce, to secure existing mobile apps using in-app embedded controls to enforce a broad range of security policies. It is sold on the Microsoft Azure cloud platform and is primarily targeted to the value-added reseller (VAR) market”.
VitalConnect granted Emergency Use Authorisation for cardiac monitoring in COVID-19 patients.
VitalConnect has been granted Emergency Use Authorisation (EUA) status by the US Food and Drug Administration (FDA) as part of the response to the COVID-19 pandemic. The EUA will enhance the capabilities of the VitalPatch and continuous patient monitoring technology, the Vista Solution.
Under the FDA EUA, the VitalPatch is now authorised to detect changes in the QT interval of hospitalised patients undergoing drug treatment for COVID-19. Drugs such as Hydroxychloroquine and Chloroquine, being used to treat COVID-19, can cause prolongation of QT intervals for patients and may lead to life-threatening arrhythmias. VitalConnect QT interval detection capabilities help enable clinicians to remotely and continuously monitor patients in real-time who may have, or develop, an elongation of QT interval as a result of their COVID-19 treatment.
“COVID-19 presents a myriad of symptoms and clinicians need access to medical devices that allow them to monitor and manage those symptoms in real-time in order to create the most appropriate treatment plans for each individual,” said Joe Roberson, chief medical officer of VitalConnect. “The enhancement of the VitalPatch receiving Emergency Use Authorisation for QT-interval detection will enable this platform to further support clinicians who are on the frontlines of treating this virus.”
As clinicians recognise and analyse the impact of COVID-19 on the heart, the ability to monitor other key vital signs provides critical information needed to develop effective treatment plans. Vista Solution, with the VitalPatch and optional 3rd party devices, measures 11 physiological vitals continuously and in real-time including body temperature, heart rate, heart rate variability, respiratory rate, and blood oxygen saturation levels.
“As we learn more about the novel coronavirus, the VitalPatch and Vista Solution platform can make a big impact on the treatment of the many people suffering across our nation,” said Peter Van Haur, CEO, VitalConnect. “Continuous, real-time monitoring enables next-level care and efficiency in the hospital and in post-discharge settings that will help clinicians treating patients on the frontlines today.”
https://magazine.cardiology2.com/feb2020/vista_solution_platform
Dott. Marcello Ruspi
Responsabile area clinica e programmazione sanitaria
CSP Telemedicine
Milano, 6 Gennaio 2021