跳至主要内容
临床试验/NCT05538143
NCT05538143Enrolling By Invitation不适用

Improving Management of Emergency Department Patients With Undifferentiated Syncope: Prospective Validation of the Canadian Syncope Risk Score

Kaiser Permanente5 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
4,000
试验地点
5
主要终点
Number of patients with arrhythmic and nonarrhythmic serious outcomes

研究概览

简要总结

Among Kaiser Permanente Northern California (KPNC) health plan members, age ≥16 years, with recent syncope and presyncope undergoing emergency department (ED) management with a point-of-care clinical decision support (CDS) tool, how well does the Canadian Syncope Risk Score predict 30-day serious outcomes that were not evident during index ED evaluation?

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Member of Kaiser Permanente Northern California (KPNC) health plan
  • Presentation to the ED with an ED diagnosis of recent syncope or presyncope (<24h) without a serious etiology identified during the initial ED diagnostic assessment, that is, patients with unexplained syncope.
  • Subjects who meet criteria will be identified electronically within the CDS tool in the electronic health record.

排除标准

  • Age <16 years old
  • Non-members of KPNC
  • Patients with obvious witnessed seizure, prolonged loss of consciousness (>5 minutes), post-traumatic loss of consciousness, and new mental status changes
  • Patients requiring hospitalization for traumatic injuries (e.g., syncope leading to motorized vehicle collision), because their outcomes may be related to trauma rather than syncope
  • Patients with impaired communication capacity, e.g., intoxication, language barriers, and dementia.

结局指标

主要结局

Number of patients with arrhythmic and nonarrhythmic serious outcomes

时间窗: 30 days

Serious outcomes include those which are arrhythmic (arrhythmias, interventions for arrhythmia, or unknown cause of death) and nonarrhythmic (e.g., myocardial infarction, structural heart disease, pulmonary embolism, or hemorrhage)

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 (5)

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