Stroke. Clinical Trial
Official title:
Study of the Safety, Feasibility and Reliability of In-ambulance Telemedicine During Paramedic Intervention Team Transportation of Patients With Suspicion of Acute Stroke.
The PreSSUB trial I will focus on prehospital telemedicine for patients with suspicion of acute stroke. The study is designed as a prospective monocentric observational trial on the safety, feasibility and reliability of in-ambulance telemedicine for patients with suspicion of acute stroke during transportation by the Paramedic Intervention Team of the Universitair Ziekenhuis Brussel.
As part of the Prehospital Stroke Study at the Universitair ziekenhuis Brussel (PreSSUB)
project, the investigators 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 been
reported and feasibility data using the 3G network in healthy volunteers are available
(unpublished data). The investigators recently evaluated the safety, technical feasibility
and reliability of in-ambulance telemedicine in patients during emergency missions by a
Paramedic Intervention Team of the Universitair Ziekenhuis Brussel (Feasibility study on
AmbulanCe-based Telemedicine, FACT) and yielded satisfactory results (paper under review,
trial registered at clinicaltrials.gov: NCT02119598).
Telestroke consultations should include standardized evaluation of key stroke features,
which can be obtained by application of validated clinical scales (e.g. Glasgow Coma Scale
for evaluation of consciousness). Prehospital assessment of stroke severity remains
challenging and inspired researchers to develop adapted scales, among which the Unassisted
TeleStroke Scale (UTSS). The UTSS has shown to be a rapid, simple, quantitative measure for
the evaluation of stroke severity through telemedicine, without need for assistance from a
third party at the patient's bedside. Moreover, it has been shown that this scale can be
used for ambulance-based telemedicine for emergent patient transportation.
The PreSSUB trial I builds further on the reassuring data obtained in a general patient
population during emergency missions in the FACT study and will focus on prehospital
telemedicine for patients with suspicion of acute stroke only.
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02053987 -
Enhanced Early Supported Discharge for Stroke in Camden
|
N/A |