Skip to main content
OpenTrials
Completed

NCT Number: NCT02230852

Prehospital Stroke Study at the Universitair Ziekenhuis Brussel I (PreSSUB I)

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitair Ziekenhuis Brussel

Brussels, Brussels Capital, 1090, Belgium

About this study

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in healthy volunteers have been reported and feasibility data using the 3G network in healthy volunteers are available (unpublished data).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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Emergency transportation by the Paramedic Intervention Team of the Universitair Ziekenhuis Brussel
  • Age >= 18 years
  • Suspicion of acute stroke with symptom onset <12 h or unknown, based on any of the symptoms mentioned in the Belgian manual for medical regulation of pre-hospital care: Hemiparesis, Facial asymmetry, Speech disturbance, Sudden, severe headache, or Confusion.

Exclusion criteria

  • Patients for whom telemedicine consultation would delay any diagnostic or therapeutic intervention.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

Study of the Safety, Feasibility and Reliability of In-ambulance Telemedicine During Paramedic Intervention Team Transportation of Patients With Suspicion of Acute Stroke.

Acronym: PreSSUB I

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 3, 2014
Registry last updated
Nov 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.