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Clinical Trials/NCT02270541
NCT02270541
Unknown
Not Applicable

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

Universitair Ziekenhuis Brussel1 site in 1 country140 target enrollmentNovember 2014
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Universitair Ziekenhuis Brussel
Enrollment
140
Locations
1
Primary Endpoint
Call-to-brain imaging time
Last Updated
10 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
February 2017
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Raf Brouns, MD, PhD

MD PhD

Universitair Ziekenhuis Brussel

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Medical events during in-ambulance telemedicine(within 2 hours)
  • Clinical outcome(upto 12 months)
  • Recanalisation therapy(upto 8 hours)

Study Sites (1)

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