跳至主要内容
临床试验/NCT03050034
NCT03050034Unknown不适用

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 Garda2 个研究点 分布在 1 个国家目标入组 296 人开始时间: 2017年2月27日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
296
试验地点
2
主要终点
Major complications reduction in subjects monitored with continuous wireless system

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Major complications reduction in subjects monitored with continuous wireless system

时间窗: 12 months

Reduction of major complications of critically ill patients from 15% to 5%.n subjects monitored with continuous wireless system

次要结局

  • Hospitalization costs reduction(12 months)

研究者

发起方
Azienda Socio Sanitaria Territoriale del Garda
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Filomena Pietrantonio

Internal Medicin Unit Director

Azienda Socio Sanitaria Territoriale del Garda

研究点 (2)

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