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临床试验/NCT02119598
NCT02119598已完成不适用

Technical and Clinical Feasibility of Third Generation In-ambulance Telemedicine: Feasibility of AmbulanCe-based Telemedicine (FACT) Study

Universitair Ziekenhuis Brussel1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
1
主要终点
Number of succesfully executed prehospital teleconsultations

研究概览

简要总结

Research on prehospital telestroke systems is recommended by the American Stroke Association, as it may facilitate early stroke diagnosis, assessment of stroke severity and selection of patients for specific stroke treatments

The experience with prehospital telemedicine for assessment of stroke severity is limited. Prehospital telestroke is a very promising concept, facilitating specialized stroke care in very early stage based on integration of bidirectional audiovisual communication with point of care laboratory analysis, vitals and decision support software.

The aim of this prospective study is to investigate the safety, the technical feasibility and the reliability of in-ambulance telemedicine using a prototype third generation telemedicine system (PreSSUB 3.0).

详细描述

Timely treatment can effectively reduce the burden of stroke and should begin with optimal prehospital stroke care. The slogans 'Time is brain' and 'Competence is brain' adequately point out that acute stroke is a time-critical medical emergency requiring specialized treatment.

Pursuant to ongoing technological developments and in line with the American Stroke Association and the European Stroke Organisation guidelines, the implementation of telestroke for optimizing inhospital stroke care is currently applied in several countries. Research on prehospital telestroke systems is recommended by the American Stroke Association, as it may facilitate early stroke diagnosis, assessment of stroke severity and selection of patients for specific stroke treatments.

The experience with prehospital telemedicine for assessment of stroke severity, however, is limited to the TeleBAT project and two recent pilot studies conducted in healthy volunteers. Prehospital telestroke is a very promising concept, facilitating specialized stroke care in very early stage based on integration of bidirectional audiovisual communication with point of care laboratory analysis, vitals and decision support software.

As part of the Prehospital Stroke Study at the Universitair ziekenhuis Brussel (PreSSUB), we have developed and tested several prototypes for prehospital telemedicine. The current system consists of commercially available hardware and a Web-based telemedicine platform. The data are transmitted to a multimedia server unit over a mobile (ultra)broadband connection (3G or 4G). Data privacy is secured by password-protected logins, role-based access control, and hypertext transfer protocol secure encryption.

The results of a feasibility study using the 4G network in healthy volunteers have recently been reported and feasibility data using the 3G network in healthy volunteers are available.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any patient older than 18 years of age requesting ambulance-based emergency care

排除标准

  • 未提供

结局指标

主要结局

Number of succesfully executed prehospital teleconsultations

时间窗: Up to 26 weeks

A successful prehospital teleconsultation is defined as a personal interaction between a patient in a moving ambulance and a remote teleconsultant, based on wireless audiovisual communication and optional reporting of vital parameters (e.g. blood pressure, blood oxygen saturation, heart rate, glycemia), neurological deficit, key history taking, medication anamnesis, and/or patient identification.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Raf Brouns, MD, PhD

M.D., Ph.D.

Universitair Ziekenhuis Brussel

研究点 (1)

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