Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-08 @ 7:57 AM
Study NCT ID:
NCT03050034
Status:
UNKNOWN
Last Update Posted:
2017-02-10
First Post:
2017-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Wireless Monitoring in Internal Medicine Unit for Ongoing Assessment of Acute Instable Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pilot perspective controlled randomized open-label single-center study to evaluate the management of critically ill patients hospitalized comparing vital signs wireless monitoring versus conventional monitoring in the first 72 h of hospitalization extendable to 5 days if the MEWS after 72 h is even greater than or equal to 3 and/or the NEWS is greater than or equal to 5.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 296}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-02-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2018-02-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-08', 'studyFirstSubmitDate': '2017-02-08', 'studyFirstSubmitQcDate': '2017-02-08', 'lastUpdatePostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Reduced nurse's time in monitoring vital parameters", 'timeFrame': '12 months', 'description': 'Reduction of minutes of nursing commitment in monitoring vital parameters/ 24h'}, {'measure': "Patients' stratification according to level of intensity of care", 'timeFrame': '12 months', 'description': 'Stratification of the patients hospitalized in Internal Medicine according to the level of intensity of care (using the MEWS score and NEWS - National Early Warning Scorei) and definition of end stage patients'}], 'primaryOutcomes': [{'measure': 'Major complications reduction in subjects monitored with continuous wireless system', 'timeFrame': '12 months', 'description': 'Reduction of major complications of critically ill patients from 15% to 5%.n subjects monitored with continuous wireless system'}], 'secondaryOutcomes': [{'measure': 'Hospitalization costs reduction', 'timeFrame': '12 months', 'description': "1 day reduction of patient's average length of hospital stay"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Wireless monitoring system', 'Acute Medicine', 'Poly-pathological patients', 'Internal Medicine core competencies', 'Acute Complex Care Model'], 'conditions': ['Wireless Vital Signs Monitoring System', 'Acutely Ill Complex and Poly-pathological Patients', 'Internal Medicine Unit Mission']}, 'referencesModule': {'references': [{'pmid': '26365373', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27499176', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29465922', 'type': 'BACKGROUND', 'citation': '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/'}, {'type': 'BACKGROUND', 'citation': "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)"}, {'pmid': '27756729', 'type': 'RESULT', 'citation': '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.'}, {'type': 'RESULT', 'citation': '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'}, {'type': 'RESULT', 'citation': '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'}, {'type': 'RESULT', 'citation': '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.'}, {'type': 'RESULT', 'citation': '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'}, {'pmid': '11588210', 'type': 'RESULT', 'citation': '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.'}, {'type': 'RESULT', 'citation': "Giovanna Bollini, Fabrizio Colombo. L'intensità assistenziale e la complessità clinica. Un progetto di ricerca della regione Lombardia. 2011"}, {'type': 'RESULT', 'citation': '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'}, {'pmid': '22828228', 'type': 'RESULT', 'citation': "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."}, {'type': 'RESULT', 'citation': 'Charles V. Sicurezza del paziente. Edizione italiana a cura di Tartaglia R, Albolino S, Bellandi T. Milano, Springer-Verlag Italia, 2012.'}, {'pmid': '25077248', 'type': 'RESULT', 'citation': '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/'}, {'type': 'RESULT', 'citation': "Bellocco A. Risk management in ospedale. Risk News CINEAS (Consorzio Universitario per l'Ingegneria nelle Assicurazioni) 2002;23."}, {'type': 'RESULT', 'citation': "Programma Integrato di Miglioramento dell'Organizzazione (PIMO, Deliberazione N° X / 3652 Seduta del 05/06/2015)"}, {'type': 'RESULT', 'citation': 'Sensium Science MF06-01, April 2015'}], 'seeAlsoLinks': [{'url': 'http://www.consort-statement.org', 'label': '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'}]}, 'descriptionModule': {'briefSummary': "The present study was planned to provide clinical data on the impact of acute and critically ill patients in Internal Medicine Unit activity and economic data enabling to quantify the relative cost of acute patients management during ordinary hospitalization. In these critically ill complex patients the vital parameters continuous monitoring could help in improving the quality of care. Therefore, the study will check how the wireless continuous monitoring in acute selected patients is able to reduce major complications improving the patient's outcome and the quality of care and reducing costs compared to traditional monitoring performed at regular intervals by the nursing staff.", 'detailedDescription': "In recent years, Internal Medicine Ward, due to epidemiological transition, takes in charge more and more an heterogeneous group of patients with serious diseases both acute and chronic and elderly, frail, poly-pathological patients, requiring intensive care. Hospitalization of medical patients in large wards without prior stratification of severity, complexity, level of dependence, comorbidities and without a proper assessment of the risk of rapid clinical deterioration, can lead to suboptimal treatment, resulting in prolonged hospital stay and increased care costs. Continuous monitoring of vital parameters may allow early detection of deterioration in acute patients not admitted in intensive care such as those hospitalized in Internal Medicine Unit, allowing the staff to immediately address the patient's needs achieving promptly the most appropriate care. As there are no studies comparing the use of wireless monitoring systems and traditional vital signs monitoring in critical acute patients, the study was designed to highlight the benefits of continuous monitoring of vital signs in the first 72 hours hospitalization to reduce the major complications and improving outcome. The study also aims to assess the reduction in hospitalization costs using as proxy the decrease in average length of stay."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all critical patients (with need for continuous monitoring and high technology) with MEWS ≥3 and / or NEWS≥5 at admission\n* all patients with glycemic decompensation regardless of MEWS and NEWS.\n* all critical patients severe fluid and electrolyte imbalance, regardless of MEWS and NEWS.\n\nExclusion Criteria:\n\n* MEWS \\<3 and or NEWS \\<5\n* Lack of informed consent\n* Inability to understand and want'}, 'identificationModule': {'nctId': 'NCT03050034', 'acronym': 'LiMS', 'briefTitle': 'Role of Wireless Monitoring in Internal Medicine Unit for Ongoing Assessment of Acute Instable Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Azienda Socio Sanitaria Territoriale del Garda'}, 'officialTitle': 'Role of Wireless Monitoring in Internal Medicine Unit for Ongoing Assessment of Acute Instable Patients: Impact on Outcomes, Length of Stay and Costs.', 'orgStudyIdInfo': {'id': 'LIMS2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vital signs wireless monitoring system', 'description': '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.', 'interventionNames': ['Device: WIN @ Hospital system']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control arm', 'description': '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.', 'interventionNames': ['Other: Traditional monitoring']}], 'interventions': [{'name': 'WIN @ Hospital system', 'type': 'DEVICE', 'description': '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).', 'armGroupLabels': ['Vital signs wireless monitoring system']}, {'name': 'Traditional monitoring', 'type': 'OTHER', 'description': 'Vital signs control performed by nurse staff each 6 hours or more, according to medical advice.', 'armGroupLabels': ['Control arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25123', 'city': 'Manerbio', 'state': 'Brescia', 'country': 'Italy', 'contacts': [{'name': 'Filomena Pietrantonio, MD', 'role': 'CONTACT', 'email': 'filomena.pietrantonio@gmail.com', 'phone': '+393291710748'}, {'name': 'Anna Bussi, MD', 'role': 'CONTACT', 'email': 'anna.bussi@asst-garda.it', 'phone': '+393389861423'}], 'facility': 'ASST-Garda Manerbio Hospital Internal Medicine Unit', 'geoPoint': {'lat': 45.3539, 'lon': 10.13803}}], 'centralContacts': [{'name': 'Filomena Pietrantonio, MD', 'role': 'CONTACT', 'email': 'filomena.pietrantonio@gmail.com', 'phone': '+393291710748'}, {'name': 'Anna Bussi, MD', 'role': 'CONTACT', 'email': 'anna.bussi@asst-garda.it', 'phone': '+393389861423'}], 'overallOfficials': [{'name': 'Filomena Pietrantonio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ASST GARDA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Socio Sanitaria Territoriale del Garda', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'ASST-Garda: Internal Medicina Unit Manerbio Hospital (BS)', 'class': 'UNKNOWN'}, {'name': 'University of Modena and Reggio Emilia', 'class': 'OTHER'}, {'name': 'Milano-Bicocca University Medical Statistic Department', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Internal Medicin Unit Director', 'investigatorFullName': 'Filomena Pietrantonio', 'investigatorAffiliation': 'Azienda Socio Sanitaria Territoriale del Garda'}}}}