Visio-conference for Pre-hospital Triage of Stroke Suspicions (OPTIC-AVC)
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|ClinicalTrials.gov Identifier: NCT04042584|
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : December 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stroke Stroke, Acute Stroke, Ischemic Cerebrovascular Disorders||Procedure: Visio conference device evaluation (DVCM)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pre-hospital Optimization of Triage of Stroke Suspicions: Bringing an Embedded Visio Conference Device|
|Actual Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||July 1, 2020|
|Estimated Study Completion Date :||July 1, 2020|
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.
- Final effective therapeutic decision [ Time Frame: Day 0 ]Thrombolysis and/or thrombectomy : yes/no
- Therapeutic conviction [ Time Frame: 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 [ Time Frame: Day 0 ]Remote evaluation failure rate
- Theoretical therapeutic decision [ Time Frame: Day 0 ]Theoretical therapeutic decision of the algorithm : thrombolysis and/or thrombectomy [yes/no]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04042584
|Contact: Ludovic LUCAS||05-56- 79-54- firstname.lastname@example.org|
|CHU de Bordeaux||Recruiting|
|Bordeaux, France, 33 076|
|Contact: Ludovic Lucas 05-56- 79-54- 45 email@example.com|