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

Not Applicable

• Conditions: Wireless Vital Signs Monitoring System; Internal Medicine Unit Mission; Acutely Ill Complex and Poly-pathological Patients
• Interventions: Other: Traditional monitoring; Device: WIN @ Hospital system

• Registration Number: NCT03050034
• Lead Sponsor: Azienda Socio Sanitaria Territoriale del Garda

Brief 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.

Study Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-08
• Study First Submitted QC: 2017-02-08
• Last Update Submitted: 2017-02-08
• Study First Posted: 2017-02-10
• Last Update Posted: 2017-02-10
• Study Start: 2017-02-27
• Primary Completion: 2017-10-27
• Study Completion: 2018-02-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 296

Inclusion Criteria

• 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.

Exclusion Criteria

• MEWS <3 and or NEWS <5
• Lack of informed consent
• Inability to understand and want

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm	Traditional monitoring	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.
Vital signs wireless monitoring system	WIN @ Hospital 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.

Primary Outcome Measures

Name	Time	Method
Major complications reduction in subjects monitored with continuous wireless system	12 months	Reduction of major complications of critically ill patients from 15% to 5%.n subjects monitored with continuous wireless system

Secondary Outcome Measures

Name	Time	Method
Hospitalization costs reduction	12 months	1 day reduction of patient's average length of hospital stay

Trial Locations

Locations (1)

ASST-Garda Manerbio Hospital Internal Medicine Unit; 🇮🇹 Manerbio, Brescia, Italy