The Use of Heliox Driven Racemic Epinephrine Nebulization in the Treatment of Moderate to Severe Bronchiolitis in Pediatric Emergency Department Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 240 Minutes
研究概览
简要总结
The purpose of this study is to assess whether children with moderate to severe bronchiolitis treated with standard racemic epinephrine therapy via 70:30 helium-oxygen (heliox) driven nebulization will have improvements in measurements of airway more rapidly than those treated with conventional air-oxygen driven nebulization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any child 2-12 months old seen in the emergency department.
- •A clinical bronchiolitis score > 3 by modified Wood's Clinical Bronchiolitis Score (M-WCBS).
- •Diagnostic criteria of bronchiolitis includes tachypnea, cough, prolonged expiratory phase, wheezing, rales, chest retractions, and hyperinflation of lungs on chest radiograph. After consenting a patient to the study, respiratory syncytial virus (RSV) infection will be tested by rapid enzyme-linked immunoabsorbent assay of nasal secretions.
排除标准
- •No child will be excluded based on race or gender
- •Patients under the age of 2 months or greater than 12 months
- •Patients with cyanotic heart disease
- •Patients with lobar pneumonia, defined by results of chest radiographs.
- •The presence of interstitial disease or diffuse patchy marking consistent with atelectasis on chest radiographs will not exclude patients.
- •Patients with croup.
- •Patients with foreign body aspiration.
- •Patients with history of cystic fibrosis, bronchopulmonary dysplasia or other chronic lung disease.
- •Patients with liver or renal disease.
- •Patients with sickle cell anemia.
- •Patients requiring mechanical ventilation.
- •Patients who develop supraventricular tachycardia secondary to racemic epinephrine administration.
- •Patients with tracheomalacia or bronchomalacia.
- •Patients who had received bronchodilators within 2 hours of initiation of the study.
- •Patients who had received systemic corticosteroids within 72 hours of enrollment
- •Patients who suffered from persistent airway hyperreactivity in the 3 months before the study.
- •Patients who do not tolerate the nasal cannulae for 45 out of 60 minutes.
研究组 & 干预措施
heliox
heliox-driven nebulizations for children with moderate to severe bronchiolitis
干预措施: heliox (Drug)
oxygen
oxygen-driven nebulizations for children with moderate to severe bronchiolitis
干预措施: oxygen (Drug)
结局指标
主要结局
Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 240 Minutes
时间窗: 240 Minutes
The Modified Wood's clinical Asthma Score is a score to measure severity of Asthma in children. There are 5 variables measured: oxygen saturation, inspiratory breath sounds, expiratory wheezing, accessory muscle involvement and cerebral function. Each variable is given a score of 0, 0.5, 1 or 2 with 2 being the most severe. The scores are combined from each variable to give a total. Total score ranges from 0 to 10, with a score of 10 (higher the score) indicating a worse outcome. We are reporting the degree of improvement in M-WCAS after assigned treatment.
次要结局
- Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times(0, 60, 120, 180 and 240 min)
- Change in Respiratory Distress Assessment Instrument (RDAI) Scores in Oxygen and Heliox Groups at Different Times(0, 60, 120, 180 and 240 mins)
研究者
In K. Kim
Professor
University of Louisville