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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Raf Brouns, MD, PhD, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT02230852
First received: August 29, 2014
Last updated: November 3, 2014
Last verified: November 2014
  Purpose
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
Stroke.

Study Type: Observational
Study Design: 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.

Further study details as provided by Raf Brouns, MD, PhD, Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • 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.



Estimated Enrollment: 40
Study Start Date: September 2014
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients older than 18 years requesting emergency care for suspicion of acute stroke
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02230852

Locations
Belgium
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
  More Information

Responsible Party: Raf Brouns, MD, PhD, MD PhD, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT02230852     History of Changes
Other Study ID Numbers: B.U.N. 143201319406
Study First Received: August 29, 2014
Last Updated: November 3, 2014

Keywords provided by Raf Brouns, MD, PhD, Universitair Ziekenhuis Brussel:
Telemedicine
Prehospital
Emergency Medicine
Stroke

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 28, 2017