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