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Feasibility of AmbulanCe-based Telemedicine (FACT) Study

NCT ID: NCT02119598

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-09-30

Brief Summary

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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).

Detailed Description

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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.

Building further on the reassuring safety and feasibility data specified above, the next logical step is to evaluate this system for prehospital telemedicine in the real-life situation involving transportation of patients in the Paramedic Ambulance team (PIT)-ambulance to the UZ Brussel.

Conditions

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Acute Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Any patient older than 18 years of age requesting ambulance-based emergency care
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Raf Brouns, MD, PhD

M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raf Brouns, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Universitair Ziekenhuis Brussel, Belgium

Locations

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Universitair Ziekenhuis Brussel

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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B.U.N. 143201317990

Identifier Type: -

Identifier Source: org_study_id