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临床试验/NCT04445493
NCT04445493已完成不适用

EPISODE-PS-COVID: hEad Pulse for Ischemic StrOke DEtection Prehospital Study During the COVID-19 Pandemic

MindRhythm, Inc.1 个研究点 分布在 1 个国家目标入组 486 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
486
试验地点
1
主要终点
Quality head pulse recordings

研究概览

简要总结

Prehospital providers encounter patients with suspected stroke frequently. Stroke and COVID-19 are related potentially putting these healthcare workers at risk of COVID-19 infection. In addition, prehospital providers need tools to help triage large vessel stroke patients to comprehensive stroke centers.

详细描述

This observational prospective study will document COVID-19 status on patients seen in the prehospital environment for suspected stroke. This will provide an estimate of how frequently stroke occurs in stroke and also the exposure risk to providers in this setting.

Additionally, patients will have a headset placed to record their headpulse during the encounter. These measurements will be used to further develop an analytic model used to predict the presence of large vessel occlusion (LVO) stroke. This may help create a device that can be used in the prehospital environment to aid in the trade decision of destination hospital.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • suspected stroke in the prehospital setting
  • patient at risk for COVID-19

排除标准

  • scalp laceration
  • Patient refusal
  • Prisoner, other vulnerable population
  • Prehospital provider feels that the recording may interfere with care

结局指标

主要结局

Quality head pulse recordings

时间窗: Through Study Completion, an average 6 months

Proportion of head pulse studies deemed of high quality for further analysis

Prevalence of COVID-19 infection in suspected stroke population

时间窗: Through Study Completion, an average of 6 months

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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