Prehospital Study at the Universitair Ziekenhuis Brussel II

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Other: Telemedicine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard pre-hospital emergency care by the Paramedic Intervention Team, in accordance with their standing operating procedures. | |
| Experimental: Telemedicine<br>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<br>* In-ambulance telemedicine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Call-to-brain imaging time | 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 | 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 | Proportion of patients with ischemic stroke receiving recanalization therapy (i.e. intravenous thrombolysis, endovascular therapy). | upto 8 hours | 
| Clinical outcome | Assessment of the functional status | upto 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Prehospital, Emergency Medicine, Stroke