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临床试验/NCT04042584
NCT04042584已完成不适用

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

University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 215 人开始时间: 2019年11月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
215
试验地点
2
主要终点
Final effective therapeutic decision

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

Visio conference device evaluation

Experimental

Neurological tele-evaluation by a neurologist

干预措施: Visio conference device evaluation (DVCM) (Procedure)

结局指标

主要结局

Final effective therapeutic decision

时间窗: Day 0

Thrombolysis and/or thrombectomy : yes/no

次要结局

  • Therapeutic conviction(Day 0)
  • Remote evaluation failure(Day 0)
  • Theoretical therapeutic decision(Day 0)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (2)

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