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

Sponsor

Universitair Ziekenhuis Brussel (Other)

Overall Status

Completed

CT.gov ID

NCT02230852

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke.

Detailed Description

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healthy volunteers have been reported and feasibility data using the 3G network in healthy volunteers are available (unpublished data).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

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 :

Sep 1, 2014

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Outcome Measures

Primary Outcome Measures

Proportion of successful in-ambulance telemedicine consultations [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitair Ziekenhuis Brussel	Brussels		Belgium	1090

Sponsors and Collaborators

Universitair Ziekenhuis Brussel

Investigators

Principal Investigator: Raf Brouns, MD PhD, Department of Neurology, Universitair Ziekenhuis Brussel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Raf Brouns, MD, PhD, MD PhD, Universitair Ziekenhuis Brussel

ClinicalTrials.gov Identifier:

NCT02230852

Other Study ID Numbers:

B.U.N. 143201319406

First Posted:

Sep 3, 2014

Last Update Posted:

Nov 4, 2014

Last Verified:

Nov 1, 2014

Keywords provided by Raf Brouns, MD, PhD, MD PhD, Universitair Ziekenhuis Brussel

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Nov 4, 2014