Role of Wireless Monitoring in Internal Medicine Unit for Ongoing Assessment of Acute Instable Patients
NCT ID: NCT03050034
Last Updated: 2017-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
296 participants
INTERVENTIONAL
2017-02-27
2018-02-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Vital signs wireless monitoring system
All patients with MEWS (Modified Early Warning Score) greater than or equal to 3 and/or NEWS (National Early Warning Score) greater than or equal to 5, at admission, regardless of the reason for hospitalization and all patients with glycemic decompensation and/or severe fluid and electrolyte imbalance, regardless of MEWS/ NEWS, undergone to continuous monitoring with wireless monitoring system WIN @ Hospital.
WIN @ Hospital system
WIN @ Hospital system is a wearable and wireless system (Medical Class IIA) that allows continuous and real-time vital signs monitoring, automatically calculating the NEWS score with a personalized alert system for the patient. It does not require the continuous presence of the nurse in front of the control room, but is working with alert on portable devices (ipad).
Control arm
All patients with MEWS (Modified Early Warning Score) greater than or equal to 3 and/or NEWS (National Early Warning Score) greater than or equal to 5, at admission, regardless of the reason for admission and all patients with glycemic decompensation and/or severe fluid and electrolyte imbalance, regardless of MEWS NEWS undergone to traditional monitoring performed at regular intervals by the nursing staff.
Traditional monitoring
Vital signs control performed by nurse staff each 6 hours or more, according to medical advice.
Interventions
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WIN @ Hospital system
WIN @ Hospital system is a wearable and wireless system (Medical Class IIA) that allows continuous and real-time vital signs monitoring, automatically calculating the NEWS score with a personalized alert system for the patient. It does not require the continuous presence of the nurse in front of the control room, but is working with alert on portable devices (ipad).
Traditional monitoring
Vital signs control performed by nurse staff each 6 hours or more, according to medical advice.
Eligibility Criteria
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Inclusion Criteria
* all patients with glycemic decompensation regardless of MEWS and NEWS.
* all critical patients severe fluid and electrolyte imbalance, regardless of MEWS and NEWS.
Exclusion Criteria
* Lack of informed consent
* Inability to understand and want
ALL
No
Sponsors
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ASST-Garda: Internal Medicina Unit Manerbio Hospital (BS)
UNKNOWN
University of Modena and Reggio Emilia
OTHER
Milano-Bicocca University Medical Statistic Department
UNKNOWN
Azienda Socio Sanitaria Territoriale del Garda
OTHER_GOV
Responsible Party
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Filomena Pietrantonio
Internal Medicin Unit Director
Principal Investigators
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Filomena Pietrantonio, MD
Role: PRINCIPAL_INVESTIGATOR
ASST GARDA
Locations
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ASST-Garda Manerbio Hospital Internal Medicine Unit
Manerbio, Brescia, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Pietrantonio F, Orlandini F, Moriconi L, La Regina M. Acute Complex Care Model: An organizational approach for the medical care of hospitalized acute complex patients. Eur J Intern Med. 2015 Dec;26(10):759-65. doi: 10.1016/j.ejim.2015.08.011. Epub 2015 Sep 11.
Pietrantonio F, Scotti E. Internal medicine network: Is it a newsworthy idea? Eur J Intern Med. 2016 Nov;35:e18-e19. doi: 10.1016/j.ejim.2016.07.024. Epub 2016 Aug 4. No abstract available.
Vincent C, Amalberti R. Safer Healthcare: Strategies for the Real World [Internet]. Cham (CH): Springer; 2016. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK481869/
Miglioramento della qualità della vita dei pazienti e riduzione del costo per il SSN attraverso l'uso di un sistema wireless di monitoraggio multi-parametrico dei parametri fisiologici. Case study sull'adozione del sistema di monitoraggio fisiologico WIN@Hospital presso l'Ospedale Campo di Marte, Lucca. Cangemi A, Turchetti B. Europe Health Summit Berlino (4-8 Maggio 2014)
Pannick S, Wachter RM, Vincent C, Sevdalis N. Rethinking medical ward quality. BMJ. 2016 Oct 18;355:i5417. doi: 10.1136/bmj.i5417. No abstract available.
E. Scotti, F. Pietrantonio. The Hospital Internal Medicine Specialist today: a literature review and the SWOT analysis to elaborate a working proposal. Italian Journal of Medicine, vol 7, n.4 2013. 278-286. 1.08.2013
F. Pietrantonio, L. Piasini, F. Spandonaro. Internal Medicine and emergency admissions: from a national Hospital Discharge Records (SDO) study to a regional analysis. . Italian Journal of Medicine Italian Journal of Medicine DOI: 10.4081/itjm.2016.674, vol 10, Issue 2, 2016
Royal College of Physicians. National Early Warning Score (NEWS) Standardising the assessment of acute-illness severity in NHS. Report of a working party, July 2012.
Orlandini F, Pietrantonio F, Moriconi L, La Regina M, Mazzone A, Campanini M. A model to improve the appropriateness in the management of acute poly-pathological patients: the acute complex care model http://dx.doi.org/10.4081/itjm.2016.697
Subbe CP, Kruger M, Rutherford P, Gemmel L. Validation of a modified Early Warning Score in medical admissions. QJM. 2001 Oct;94(10):521-6. doi: 10.1093/qjmed/94.10.521.
Giovanna Bollini, Fabrizio Colombo. L'intensità assistenziale e la complessità clinica. Un progetto di ricerca della regione Lombardia. 2011
Mongardi M, Bassi E, Di Ruscio E. Ospedale per Intensità di cura: strumenti per la classificazione dei pazienti. DGSPS, Servizio Presidi Ospedalieri, Regione Emilia-Romagna, Febbraio 2015
Tartaglia R, Albolino S, Bellandi T, Bianchini E, Biggeri A, Fabbro G, Bevilacqua L, Dell'erba A, Privitera G, Sommella L. [Adverse events and preventable consequences: retrospective study in five large Italian hospitals]. Epidemiol Prev. 2012 May-Aug;36(3-4):151-61. Italian.
Charles V. Sicurezza del paziente. Edizione italiana a cura di Tartaglia R, Albolino S, Bellandi T. Milano, Springer-Verlag Italia, 2012.
Institute of Medicine (US) Committee on Quality of Health Care in America; Kohn LT, Corrigan JM, Donaldson MS, editors. To Err is Human: Building a Safer Health System. Washington (DC): National Academies Press (US); 2000. Available from http://www.ncbi.nlm.nih.gov/books/NBK225182/
Bellocco A. Risk management in ospedale. Risk News CINEAS (Consorzio Universitario per l'Ingegneria nelle Assicurazioni) 2002;23.
Programma Integrato di Miglioramento dell'Organizzazione (PIMO, Deliberazione N° X / 3652 Seduta del 05/06/2015)
Sensium Science MF06-01, April 2015
Related Links
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Moher D, Hopewell S, Shulz KF, et al . The CONSORT statement: revised reccomendations for improving the quality of reports of parallel-group randomized trials.Evidence 2012; 4 (7): e1000024 www.consort-statement.org
Other Identifiers
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LIMS2017
Identifier Type: -
Identifier Source: org_study_id
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