Prehospital Stroke Study at the Universitair Ziekenhuis Brussel I (PreSSUB I) (PreSSUB I)
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|ClinicalTrials.gov Identifier: NCT02230852|
Recruitment Status : Completed
First Posted : September 3, 2014
Last Update Posted : November 4, 2014
|Condition or disease|
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in healthy volunteers have been reported and feasibility data using the 3G network in healthy volunteers are available (unpublished data).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.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|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.|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
- Proportion of successful in-ambulance telemedicine consultations [ Time Frame: upto 26 weeks ]
The proportion of successful in-ambulance telemedicine consultations, defined as the number of successful in-ambulance teleconsultations compared to all attempted in-ambulance teleconsultations.
A successful teleconsultation is defined as an interaction between the patient in the ambulance and a remote teleconsultant, that results in a medical intervention and/or timely communication of medically relevant information to the inhospital team.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02230852
|Universitair Ziekenhuis Brussel|
|Brussels, Belgium, 1090|
|Principal Investigator:||Raf Brouns, MD PhD||Department of Neurology, Universitair Ziekenhuis Brussel|