<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02230852</url>
  </required_header>
  <id_info>
    <org_study_id>B.U.N. 143201319406</org_study_id>
    <nct_id>NCT02230852</nct_id>
  </id_info>
  <brief_title>Prehospital Stroke Study at the Universitair Ziekenhuis Brussel I (PreSSUB I)</brief_title>
  <acronym>PreSSUB I</acronym>
  <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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitair Ziekenhuis Brussel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitair Ziekenhuis Brussel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The PreSSUB trial I will focus on prehospital telemedicine for patients with suspicion of&#xD;
      acute stroke. The study is designed as a prospective monocentric observational trial on the&#xD;
      safety, feasibility and reliability of in-ambulance telemedicine for patients with suspicion&#xD;
      of acute stroke during transportation by the Paramedic Intervention Team of the Universitair&#xD;
      Ziekenhuis Brussel.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As part of the Prehospital Stroke Study at the Universitair ziekenhuis Brussel (PreSSUB)&#xD;
      project, the investigators have developed and tested several prototypes for prehospital&#xD;
      telemedicine. The current system consists of commercially available hardware and a Web-based&#xD;
      telemedicine platform. The data are transmitted to a multimedia server unit over a mobile&#xD;
      (ultra)broadband connection (3G or 4G). Data privacy is secured by password-protected logins,&#xD;
      role-based access control, and hypertext transfer protocol secure encryption.&#xD;
&#xD;
      The results of a feasibility study using the 4G network in healthy volunteers have been&#xD;
      reported and feasibility data using the 3G network in healthy volunteers are available&#xD;
      (unpublished data). The investigators recently evaluated the safety, technical feasibility&#xD;
      and reliability of in-ambulance telemedicine in patients during emergency missions by a&#xD;
      Paramedic Intervention Team of the Universitair Ziekenhuis Brussel (Feasibility study on&#xD;
      AmbulanCe-based Telemedicine, FACT) and yielded satisfactory results (paper under review,&#xD;
      trial registered at clinicaltrials.gov: NCT02119598).&#xD;
&#xD;
      Telestroke consultations should include standardized evaluation of key stroke features, which&#xD;
      can be obtained by application of validated clinical scales (e.g. Glasgow Coma Scale for&#xD;
      evaluation of consciousness). Prehospital assessment of stroke severity remains challenging&#xD;
      and inspired researchers to develop adapted scales, among which the Unassisted TeleStroke&#xD;
      Scale (UTSS). The UTSS has shown to be a rapid, simple, quantitative measure for the&#xD;
      evaluation of stroke severity through telemedicine, without need for assistance from a third&#xD;
      party at the patient's bedside. Moreover, it has been shown that this scale can be used for&#xD;
      ambulance-based telemedicine for emergent patient transportation.&#xD;
&#xD;
      The PreSSUB trial I builds further on the reassuring data obtained in a general patient&#xD;
      population during emergency missions in the FACT study and will focus on prehospital&#xD;
      telemedicine for patients with suspicion of acute stroke only.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of successful in-ambulance telemedicine consultations</measure>
    <time_frame>upto 26 weeks</time_frame>
    <description>The proportion of successful in-ambulance telemedicine consultations, defined as the number of successful in-ambulance teleconsultations compared to all attempted in-ambulance teleconsultations.&#xD;
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.</description>
  </primary_outcome>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Stroke.</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients older than 18 years requesting emergency care for suspicion of acute stroke&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Emergency transportation by the Paramedic Intervention Team of the Universitair&#xD;
             Ziekenhuis Brussel&#xD;
&#xD;
          -  Age &gt;= 18 years&#xD;
&#xD;
          -  Suspicion of acute stroke with symptom onset &lt;12 h or unknown, based on any of the&#xD;
             symptoms mentioned in the Belgian manual for medical regulation of pre-hospital care:&#xD;
             Hemiparesis, Facial asymmetry, Speech disturbance, Sudden, severe headache, or&#xD;
             Confusion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients for whom telemedicine consultation would delay any diagnostic or therapeutic&#xD;
             intervention.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raf Brouns, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Neurology, Universitair Ziekenhuis Brussel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Brussel</name>
      <address>
        <city>Brussels</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>November 3, 2014</last_update_submitted>
  <last_update_submitted_qc>November 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 4, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitair Ziekenhuis Brussel</investigator_affiliation>
    <investigator_full_name>Raf Brouns, MD, PhD</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <keyword>Telemedicine</keyword>
  <keyword>Prehospital</keyword>
  <keyword>Emergency Medicine</keyword>
  <keyword>Stroke</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02230852
org study id: B.U.N. 143201319406
nct id: NCT02230852
lead sponsor: 
has dmc: No
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
measure: Proportion of successful in-ambulance telemedicine consultations
time frame: upto 26 weeks
description: 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.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Raf Brouns, MD PhD
role: Principal Investigator
affiliation: Department of Neurology, Universitair Ziekenhuis Brussel
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Universitair Ziekenhuis Brussel
investigator full name: Raf Brouns, MD, PhD
investigator title: MD PhD
mesh term: Stroke