OPTIC-AVC: Visio-conference for Pre-hospital Triage of Stroke Suspicions

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Completed

CT.gov ID

NCT04042584

Collaborator

(none)

215

Enrollment

Location

Arm

24.6

Actual Duration (Months)

8.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Stroke, Acute Stroke, Ischemic Cerebrovascular Disorders	Procedure: Visio conference device evaluation (DVCM)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

215 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Nov 20, 2019

Actual Primary Completion Date :

Dec 9, 2021

Actual Study Completion Date :

Dec 9, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Visio conference device evaluation Neurological tele-evaluation by a neurologist	Procedure: Visio conference device evaluation (DVCM) 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.

Arm

Intervention/Treatment

Experimental: Visio conference device evaluation

Neurological tele-evaluation by a neurologist

Procedure: Visio conference device evaluation (DVCM)

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.

Outcome Measures

Primary Outcome Measures

Final effective therapeutic decision [Day 0]
Thrombolysis and/or thrombectomy : yes/no

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)