Prehospital Study at the Universitair Ziekenhuis Brussel II

Not Applicable

• Conditions: Stroke
• Interventions: Other: Telemedicine

• Registration Number: NCT02270541
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Study Timeline

• Study First Submitted: 2014-10-16
• Study First Submitted QC: 2014-10-20
• Study First Posted: 2014-10-21
• Study Start: 2014-11
• Primary Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-01
• Last Update Posted: 2016-03-02
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemedicine	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.

Primary Outcome Measures

Name	Time	Method
Call-to-brain imaging time	within 2 hours	Interval between emergency call and imaging of the brain by computed tomography or magnetic resonance imaging in the hospital.

Secondary Outcome Measures

Name	Time	Method
Medical events during in-ambulance telemedicine	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)
Clinical outcome	upto 12 months	Assessment of the functional status
Recanalisation therapy	upto 8 hours	Proportion of patients with ischemic stroke receiving recanalization therapy (i.e. intravenous thrombolysis, endovascular therapy).

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Brussels, Belgium