Visio-conference for Pre-hospital Triage of Stroke Suspicions

Not Applicable

Completed

• Conditions: Stroke, Acute; Cerebrovascular Disorders; Stroke, Ischemic; Stroke
• Interventions: Procedure: Visio conference device evaluation (DVCM)

• Registration Number: NCT04042584
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2019-07-31
• Study First Submitted QC: 2019-07-31
• Study First Posted: 2019-08-02
• Study Start: 2019-11-20
• Primary Completion: 2021-12-09
• Study Completion: 2021-12-09
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Visio conference device evaluation	Visio conference device evaluation (DVCM)	Neurological tele-evaluation by a neurologist

Primary Outcome Measures

Name	Time	Method
Final effective therapeutic decision	Day 0	Thrombolysis and/or thrombectomy : yes/no

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France