NCT03050034

Role of Wireless Monitoring in Internal Medicine Unit for Ongoing Assessment of Acute Instable Patients

Role of Wireless Monitoring in Internal Medicine Unit for Ongoing Assessment of Acute Instable Patients: Impact on Outcomes, Length of Stay and Costs.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 296 (estimated)
• Sponsor: Azienda Socio Sanitaria Territoriale del Garda · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Wireless Vital Signs Monitoring System
• Acutely Ill Complex and Poly-pathological Patients
• Internal Medicine Unit Mission

Interventions

Type	Name	Description
DEVICE	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).
OTHER	Traditional monitoring	Vital signs control performed by nurse staff each 6 hours or more, according to medical advice.

Timeline

• Start date: 2017-02-27
• Primary completion: 2017-10-27
• Completion: 2018-02-27
• First posted: 2017-02-10
• Last updated: 2017-02-10

Locations

1 site across 1 country: Italy