Prehospital Study at the Universitair Ziekenhuis Brussel II (PreSSUB II)

March 1, 2016 updated by: Raf Brouns, MD, PhD, Universitair Ziekenhuis Brussel

Single-center Clinical Trial Evaluating the Efficacy, Safety, Feasibility, Reliability, and Cost-effectiveness of In-ambulance Telemedicine for Patients With Suspicion of Acute Stroke

Interventional prospective randomized open blinded end-point (PROBE) single-center clinical trial on the evaluation of the efficacy, safety, feasibility, reliability, and cost-effectiveness of in-ambulance telemedicine for patients with suspicion of acute stroke.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The purpose of PreSSUB II is to evaluate the efficacy, safety, feasibility, reliability and cost-effectiveness of in-ambulance telemedicine during Paramedic Intervention Team transportation of patients with suspicion of acute stroke.

The implementation of expert stroke support in the pre-hospital arena using in-ambulance telemedicine is an innovative approach that opens up new perspectives and allows continuous guidance by a stroke specialist throughout the acute stroke care continuum.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1090
        • Universitair Ziekenhuis Brussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 in-ambulance telemedicine consultation would delay any diagnostic or therapeutic intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Standard pre-hospital emergency care by the Paramedic Intervention Team, in accordance with their standing operating procedures.
Experimental: Telemedicine
In-ambulance teleconsultation by a stroke expert aiming to support the Paramedic Intervention Team by focusing on patient identification, obtaining homeostasis (optimal control of blood pressure, blood oxygenation, temperature, heart rate and rhythm, glycemia), assessment of the patient's neurological status, stroke diagnosis, hospital notification, and patient selection for specific stroke treatment.
Other: Telemedicine
In-ambulance telemedicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Call-to-brain imaging time
Time Frame: within 2 hours
Interval between emergency call and imaging of the brain by computed tomography or magnetic resonance imaging in the hospital.
within 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medical events during in-ambulance telemedicine
Time Frame: within 2 hours
Prevalence of medical events diagnosed and corrected during in-ambulance telemedicine (e.g. blood oxygen desaturation, arterial hypertension, arterial hypotension, hypoglycemia, hyperglycemia, cardiac arrhythmia, decreased level of consciousness, hyperthermia)
within 2 hours
Recanalisation therapy
Time Frame: upto 8 hours
Proportion of patients with ischemic stroke receiving recanalization therapy (i.e. intravenous thrombolysis, endovascular therapy).
upto 8 hours
Clinical outcome
Time Frame: upto 12 months
Assessment of the functional status
upto 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: upto 100 days
Mortality 90 (± 10) days after stroke
upto 100 days
Adverse event
Time Frame: upto 12 months
In-hospital mortality and any adverse event, in particular known complications of delayed stroke care and thrombolytic therapy (e.g. intracranial hemorrhage, systemic bleeding requiring transfusion, inappropriate use of recanalization therapy)
upto 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Collaborators

Vrije Universiteit Brussel
Research Foundation Flanders
King Baudouin Foundation
Brussels Institute for Research and Innovation (INNOVIRIS)

Investigators

  • Study Chair: Jacques De Keyser, MD PhD, Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

October 16, 2014

First Submitted That Met QC Criteria

October 20, 2014

First Posted (Estimate)

October 21, 2014

Study Record Updates

Last Update Posted (Estimate)

March 2, 2016

Last Update Submitted That Met QC Criteria

March 1, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-003463-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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