Visio-conference for Pre-hospital Triage of Stroke Suspicions

Study Overview
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Brief Summary
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Interventionnal Study to investigate the accuracy of our clinical based algorithm performed by using a visioconference device to assess the eligibility of acute recanalisation treatment (intraveinous thrombolysis (IVT) and/or mechanical thrombectomie (TM). Clinical identification of type of treatment is needed is pre-hospital triage of these patients.

Detailed Description
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The outcome of ischemic stroke (IS) with large artery occlusion (LVO) is related to the volume of infarcted brain witch is related to the delay of arterial recanalisation. IVT is available in multiple stroke units in France but, in case of LVO, the association with TM is needed. The availability of endovascular capable centers is limited to tertiary care hospitals. As a result, pre-hospital identification of these patients is a priority and the optimization of the triage can be done by a clinical algorithm carried out by a neurological tele-evaluation. OPTIC-AVC is a multi-phase study. This phase is about the evaluation of accuracy of our algorithm performed by a quick and standardized neurological tele-evaluation to predict the eligibility for recanalisation treatment (IVT and/or TM) of patients suspected of acute stroke in the emergency setting. The effective therapeutic decision for each patient, performed by another neurologist, will be blind to the theoretical therapeutic decision resulting from the algorithm. Theoretical and effective therapeutic decision will be compared a posteriori

Official Title
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Pre-hospital Optimization of Triage of Stroke Suspicions: Bringing an Embedded Visio Conference Device

Conditions
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Stroke, Stroke, Acute, Stroke, Ischemic, Cerebrovascular Disorders

Intervention / Treatment
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* Procedure: Visio conference device evaluation (DVCM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 Suspicion of acute symptomatic stroke whose first symptoms are less than 24 hours old Free Consent, informed writing signed by the participant or the person of confidence and the investigator (no later than the day of inclusion and before any examination required by research) Exclusion Criteria: Stupor or coma requiring orotracheal intubation Rankin pre stroke > 4 Severe cognitive impairement Contraindication to the realiszation of angiographic imaging Participation refusal Patient under legal protection

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Visio conference device evaluation<br>Neurological tele-evaluation by a neurologist | Procedure: Visio conference device evaluation (DVCM)<br>* Standard neurological tele-evaluation (limited to 15minutes) remotely carried out by a first neurologist via a tablet (DVCM) and an operator. A second neurologist assist at the assessment without intervention next to the patient. Once the remote assessment is complet, the second neurologist ensure the continuation of standard patient care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final effective therapeutic decision | Thrombolysis and/or thrombectomy : yes/no | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic conviction | Theoretical conviction using Likert scales between the neurologist at the patient bedside and the neurologist using the device for tele-evaluation | Day 0 | 
| Remote evaluation failure | Remote evaluation failure rate | Day 0 | 
| Theoretical therapeutic decision | Theoretical therapeutic decision of the algorithm : thrombolysis and/or thrombectomy [yes/no] | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Mechanical thrombectomy, Tele-evaluation, Emergency medical service, Pre hospital