Feasibility of AmbulanCe-based Telemedicine (FACT) Study (FACT)

December 1, 2014 updated by: Raf Brouns, MD, PhD, Universitair Ziekenhuis Brussel

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

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).

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1090
        • Universitair Ziekenhuis Brussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Any patient older than 18 years requesting ambulance-based emergency care.

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of succesfully executed prehospital teleconsultations
Time Frame: 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.
Up to 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: Raf Brouns, M.D., Ph.D., Department of Neurology, Universitair Ziekenhuis Brussel, Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

April 12, 2014

First Submitted That Met QC Criteria

April 18, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.U.N. 143201317990

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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