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Clinical Trials/NCT03050034
NCT03050034
Unknown
Not Applicable

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

Azienda Socio Sanitaria Territoriale del Garda1 site in 1 country296 target enrollmentFebruary 27, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Wireless Vital Signs Monitoring System
Sponsor
Azienda Socio Sanitaria Territoriale del Garda
Enrollment
296
Locations
1
Primary Endpoint
Major complications reduction in subjects monitored with continuous wireless system
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 27, 2017
End Date
February 27, 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Azienda Socio Sanitaria Territoriale del Garda
Responsible Party
Principal Investigator
Principal Investigator

Filomena Pietrantonio

Internal Medicin Unit Director

Azienda Socio Sanitaria Territoriale del Garda

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Hospitalization costs reduction(12 months)

Study Sites (1)

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