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临床试验/NCT03962894
NCT03962894已完成4 期

Early Administration of Steroids in the Ambulance Setting: An Observational Design Trial

University of Florida7 个研究点 分布在 1 个国家目标入组 834 人开始时间: 2019年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
834
试验地点
7
主要终点
Hospital Admission

研究概览

简要总结

Asthma is the most common chronic disease of childhood and is a leading cause of emergency medical treatment. For children experiencing an asthma exacerbation, emergency department (ED) guidelines recommend early systemic corticosteroid (CS) administration, since studies have shown associated, time-sensitive, decreases in hospital admissions and ED length-of-stay (LOS). For patients who are treated by 911 emergency medical services (EMS) first, there exists an opportunity for even earlier administration of CS, prior to ED arrival. Yet, preliminary data demonstrate that currently less than 10% of EMS pediatric asthma patients receive CS prior to ED arrival.

Given the known time-sensitivity of CS' effects on patient outcomes, the investigators hypothesize that even earlier EMS administration of CS will decrease hospital admissions, ED LOS, and intensive care unit admissions for pediatric patients with an acute asthma exacerbation. Using a pragmatic observation design in multiple EMS agencies, we will enroll patients to analyze clinical outcomes and comparative costs of EMS CS administration, and how both are influenced by EMS transport time. That novel combination of analyses will help build evidence-based guidelines adaptable for diverse EMS agencies nationwide.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • primary problem: Asthma exacerbation
  • stable to take an oral medication
  • transported by EMS to an ED

排除标准

  • unconscious, hemodynamically unstable, or critically ill -> EMS will proceed with usual critical care (includes IV methylprednisolone as per protocol)
  • daily or every other day corticosteroid therapy
  • allergy to prednisolone or another corticosteroid
  • chronic lung disease besides asthma, airway anatomic abnormalities, tracheostomy, immunocompromised, traumatic injury, pregnancy, law enforcement custody, non-English speaking

研究组 & 干预措施

Early Prehospital Systemic Corticosteroids

Experimental

Children with asthma attacks who receive systemic corticosteroids in the prehospital environment by emergency medical services

干预措施: Prednisolone (Drug)

结局指标

主要结局

Hospital Admission

时间窗: Day 1 (ED stay)

Number of admissions to an inpatient unit (general or ICU) for an asthma exacerbation

次要结局

  • Emergency Department Length-of-stay(Day 1 (from EMS arrival to ED disposition))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (7)

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