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临床试验/NCT05492474
NCT05492474招募中不适用

Cranial Ultrasound for Prehospital ICH Diagnosis (CUPID_EMS)

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Success Rate for cPOCUS Exams

研究概览

简要总结

To evaluate the feasibility of Emergency Medical System (EMS)-performed cPOCUS in the field for diagnosis of acute Intracerebral hemorrhage (ICH)

详细描述

With the over-arching goal of achieving early diagnosis of Intracerebral hemorrhage (ICH) with cPOCUS, this study hypothesizes that (a) Emergency Medical System (EMS) personnel can competently perform cPOCUS in the field in a timely fashion in a large majority of stroke patients; (b) acquired POCUS images can be successfully and securely transmitted for a remote physician interpretation in a timely manner; and (c) cPOCUS will have a greater sensitivity and specificity than clinical scores as a screening tool for ICH identification in pre-hospital settings.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
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

  • Any patient deemed to have a stroke like presentation or possibility of brain hemorrhage in the clinical judgement of the Emergency Medical Services (EMS) provider and a decision to transfer the patient to the nearest Emergency Department (ED) for further evaluation has been made will be eligible for the study
  • 18 years old or older
  • transfer initiated by EMS to the ED for further evaluation
  • performing ultrasound will not interfere with the care or triage as part of routine care

排除标准

  • less than 18 years old
  • incarcerate patients
  • penetrating cranial/head trauma or scalp wound
  • any patient where performing ultrasound will interfere with the care
  • patients who decide not to be transported to ED

结局指标

主要结局

Success Rate for cPOCUS Exams

时间窗: Year 1

cPOCUS will be attempted and performed on about 1000 patients over 12 months by 30 EMS providers

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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