Clinical trial NCT02119598: Feasibility of AmbulanCe-based Telemedicine (FACT) Study
Official title: Technical and Clinical Feasibility of Third Generation In-ambulance Telemedicine: Feasibility of AmbulanCe-based Telemedicine (FACT) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Stroke
Keywords: Prehospital care
Telemedicine
Ambulance-based telemedicine
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any patient older than 18 years requesting ambulance-based emergency care.

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Number of succesfully executed prehospital teleconsultations
timeFrame: Up to 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
Study officials:
affiliation: Department of Neurology, Universitair Ziekenhuis Brussel, Belgium
name: Raf Brouns, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: