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临床试验/NCT02863666
NCT02863666已完成不适用

Verification of a Prediction Algorithm for Cardiopulmonary Patients Admitted to the Emergency Department (ED) (VPAC)

Zoll Medical Corporation3 个研究点 分布在 2 个国家目标入组 673 人开始时间: 2016年8月11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
673
试验地点
3
主要终点
Number of Subjects With a Cardiopulmonary Event

研究概览

简要总结

Prospective observational clinical study to verify an algorithm used to predict cardiopulmonary events in patients presenting to the emergency department.

详细描述

A novel algorithm for determining risk of acute cardiac complications, including cardiac arrest, for patients presenting to the ED has recently been reported. Unlike prior risk stratification tools that relied on basic vital sign data, this algorithm utilizes advanced computing of ECG data to solve the risk classification problem. Data will be collected on patients presenting to the emergency department with a primary complaint that is determined to be cardiopulmonary of origin by a clinician.

Verification of the results of the previous studies using this algorithm in a more diverse patient cohorts is required. As such, the proposed study will investigate the accuracy of the algorithm.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • 18 years of age or older Admission to emergency department requiring immediate medical attention due to presumed cardiac or pulmonary cause(s) and considered 2nd or 3rd tier priority in triage system.

排除标准

  • Pregnant or suspected pregnancy Significant trauma Do Not Resuscitate order Known as Ward of the State

结局指标

主要结局

Number of Subjects With a Cardiopulmonary Event

时间窗: Within 72 hours of presentation to ED

The number of any cardiopulmonary event, not limited to: Cardiac arrest Sustained ventricular tachycardia (VT) Hypotension requiring inotropes or intra-aortic balloon pump (IABP) insertion Intubation or mechanical ventilation Complete heart block Bradycardia requiring insertion of a pacing wire or external pacing, and Percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG)

次要结局

  • Cumulative Number of Cardiopulmonary Events in a Single Subject(Within 72 hours of presentation to ED)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (3)

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