Wireless Vital Signs Monitoring SystemLiMSNCT03050034
Role of Wireless Monitoring in Internal Medicine Unit for Ongoing Assessment of Acute Instable Patients
A study testing WIN @ Hospital system and Traditional monitoring in people with Wireless Vital Signs Monitoring System and Acutely Ill Complex and Poly-pathological Patients, run by Azienda Socio Sanitaria Territoriale del Garda at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wireless Vital Signs Monitoring System, Acutely Ill Complex and Poly-pathological Patients, Internal Medicine Unit Mission
- What is being tested?
- WIN @ Hospital system and Traditional monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteItaly
- Study dates
- 27 Feb 2017to 27 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all critical patients (with need for continuous monitoring and high technology) with MEWS ≥3 and / or NEWS≥5 at admission
- all patients with glycemic decompensation regardless of MEWS and NEWS.
- all critical patients severe fluid and electrolyte imbalance, regardless of MEWS and NEWS.
Who cannot join
- MEWS <3 and or NEWS <5
- Lack of informed consent
- Inability to understand and want
Trial locations and contacts
1 site in 1 country.
Italy1 site
ASST-Garda Manerbio Hospital Internal Medicine Unit
Manerbio, Brescia, 25123
Filomena Pietrantonio, MD, +393291710748, filomena.pietrantonio@gmail.com
Anna Bussi, MD, +393389861423, anna.bussi@asst-garda.it
About this study
Official title: Role of Wireless Monitoring in Internal Medicine Unit for Ongoing Assessment of Acute Instable Patients: Impact on Outcomes, Length of Stay and Costs.
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.
Read the detailed description
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.
- Conditions
- Wireless Vital Signs Monitoring System, Acutely Ill Complex and Poly-pathological Patients, Internal Medicine Unit Mission
- Being tested
- WIN @ Hospital system, Traditional monitoring
- Keywords
- Wireless monitoring system, Acute Medicine, Poly-pathological patients, Internal Medicine core competencies, Acute Complex Care Model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WIN @ Hospital systemDevice
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 monitoringOther
Vital signs control performed by nurse staff each 6 hours or more, according to medical advice.
| Study group | Role | What they receive |
|---|---|---|
| Vital signs wireless monitoring system | Experimental | 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. Receives: Device: WIN @ Hospital system |
| Control arm | Active comparator | 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. Receives: Other: Traditional monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major complications reduction in subjects monitored with continuous wireless system
Reduction of major complications of critically ill patients from 15% to 5%.n subjects monitored with continuous wireless system
Measured: 12 months
Secondary outcomes (1)
Hospitalization costs reduction
1 day reduction of patient's average length of hospital stay
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start27 Feb 2017 (estimated)
- Primary completion27 Oct 2017 (estimated)
- Study completion27 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Wireless Vital Signs Monitoring SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale del Garda
- Sponsor type
- Other government
- Collaborators
- ASST-Garda: Internal Medicina Unit Manerbio Hospital (BS), University of Modena and Reggio Emilia, Milano-Bicocca University Medical Statistic Department
- Responsible party
- Principal investigator, Filomena Pietrantonio, Azienda Socio Sanitaria Territoriale del Garda
- Investigators
- Filomena Pietrantonio, MD, Principal investigator, ASST GARDA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050034
- Sponsor's protocol ID
- LIMS2017
- Acronym
- LiMS
- Status last verified
- Feb 2017
- First submitted
- 8 Feb 2017
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26365373Pietrantonio 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.
PubMed 27499176Vincent 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/
PubMed 29465922Miglioramento 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.
PubMed 27756729E. 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.
PubMed 11588210Giovanna 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.
PubMed 22828228Charles 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/
PubMed 25077248
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Wireless Monitoring in Internal Medicine Unit for Ongoing Assessment of Acute Instable Patients: Impact on Outcomes, Length of Stay and Costs.
- ClinicalTrials.gov ID
- NCT03050034
- Acronym / sponsor ID
- LiMS / LIMS2017
- Conditions
- Wireless Vital Signs Monitoring System, Acutely Ill Complex and Poly-pathological Patients, Internal Medicine Unit Mission
- Keywords
- Wireless monitoring system, Acute Medicine, Poly-pathological patients, Internal Medicine core competencies, Acute Complex Care Model
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale del GardaOther government
- Collaborators
- ASST-Garda: Internal Medicina Unit Manerbio Hospital (BS), University of Modena and Reggio Emilia, Milano-Bicocca University Medical Statistic Department
- Study start
- 27 Feb 2017 (estimated)
- Primary completion
- 27 Oct 2017 (estimated)
- Study completion
- 27 Feb 2018 (estimated)
- First posted
- 10 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Vital signs wireless monitoring system | Experimental | Device: WIN @ Hospital systemAll 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. |
| Control arm | Active comparator | Other: Traditional monitoringAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- all critical patients (with need for continuous monitoring and high technology) with MEWS ≥3 and / or NEWS≥5 at admission
- all patients with glycemic decompensation regardless of MEWS and NEWS.
- all critical patients severe fluid and electrolyte imbalance, regardless of MEWS and NEWS.
Key exclusion criteria (3 listed)
- MEWS <3 and or NEWS <5
- Lack of informed consent
- Inability to understand and want
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WIN @ Hospital systemWIN @ 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). | Device | Vital signs wireless monitoring system |
| Traditional monitoringVital signs control performed by nurse staff each 6 hours or more, according to medical advice. | Other | Control arm |
Primary outcome
Major complications reduction in subjects monitored with continuous wireless system
Time frame: 12 months
Reduction of major complications of critically ill patients from 15% to 5%.n subjects monitored with continuous wireless system
1 secondary outcome
Hospitalization costs reduction
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Background: PubMed 26365373Pietrantonio 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.
- Background: PubMed 27499176Pietrantonio 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.
- Background: PubMed 29465922Vincent 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/
- BackgroundMiglioramento 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)
- Results publication: PubMed 27756729Pannick 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.
- Results publicationE. 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
- Results publicationF. 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
- Results publicationRoyal College of Physicians. National Early Warning Score (NEWS) Standardising the assessment of acute-illness severity in NHS. Report of a working party, July 2012.
- Results publicationOrlandini 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
- Results publication: PubMed 11588210Subbe 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.
- Results publicationGiovanna Bollini, Fabrizio Colombo. L'intensità assistenziale e la complessità clinica. Un progetto di ricerca della regione Lombardia. 2011
- Results publicationMongardi 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
- 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.orgLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Wireless Vital Signs Monitoring System
Recruiting
Feasibility of Wireless Continuous Vital Sign Monitoring and Impact on Patients Undergoing Adult Spinal Surgery in a General Ward
Adult Spinal Deformity, Wireless Continuous Vital Signs Monitoring
Not yet recruitingObservational study
Neonatal Wireless Transmission System: Hospital Adoption and Planning for Implementation Study
Preterm Infants, Vital Sign Monitoring
RecruitingObservational study
Alert Frequency, Nurse, and Patient Satisfaction With a wCVSM Software Across Health Care Systems and Cultures
User Experience, Postoperative Complications
Recruiting
Effect of ANNE One-Wellue Device Array Use on Staff Bedside Vital Sign Measurement Activity
Vital Sign Evaluation, Vital Sign Monitoring
Recruiting
Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System
Postoperative Complications, Cancer, Treatment-Related
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filomena Pietrantonio, MD principal investigator
ASST GARDA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WIN @ Hospital system and Traditional monitoring in people with Wireless Vital Signs Monitoring System and Acutely Ill Complex and Poly-pathological Patients, run by Azienda Socio Sanitaria Territoriale del Garda at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Filomena Pietrantonio, MD (+393291710748, filomena.pietrantonio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major complications reduction in subjects monitored with continuous wireless system (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03050034, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.