A Randomized Trial Comparing Metered Dose Inhalers and Breath Actuated Nebulizers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 980
- 主要终点
- Number of Participant's Admitted to the Hospital for Further Treatment
研究概览
简要总结
This study is determines if metered dose inhalers are as effective as breath actuated nebulizers for the treatment of mild to moderate asthma exacerbations in pediatric patients presenting to the emergency department. Half of the participating patients received albuterol via the metered dose inhaler whereas the other half received albuterol via the breath actuated nebulizer.
详细描述
Albuterol administered via metered dose inhalers with spacers are more effective than small volume nebulizers in the treatment of acute pediatric asthma exacerbations. There is also supporting data that the breath actuated nebulizers are also more effective than small volume nebulizers. The effectiveness of breath actuated nebulization compared to MDI for treating asthma exacerbations is less well defined.
Metered dose inhalers with spacers are more readily available to the general population, are easily transportable and do not require a power source. Demonstrating equal effectiveness of albuterol delivery systems for treatment of acute pediatric asthma exacerbations would enable physicians to confidently utilize clinical encounters as opportunities to educate families on management of asthma exacerbations using their home appliance.
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
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting either with a first time wheeze or with an asthma exacerbation of a mild to moderate severity, both defined by a pediatric asthma score (PAS)11 of 5 to 11.
排除标准
- •Subjects were excluded if they had initiated therapy at an outlying medical facility or had a history of any chronic lung disease
- •Congenital heart disease, tracheostomy, or were receiving diuretic therapy.
- •Patients diagnosed by the treating physician with bronchiolitis or pneumonia were excluded along with children who were wards of the state or whose parents did not speak English.
研究组 & 干预措施
Albuterol Breath Actuated Nebulizer
Subjects randomized to BAN were evaluated for proper breath actuation technique. For subjects unable to coordinate breath actuation, the RT attached an appropriately sized mask to the device, changed the setting to continuous nebulization and returned upon completion of the treatment. Albuterol dosing was based upon the subject's weight and presenting symptom severity. Children presenting in the mild and moderate severity category weighing less than 20kg, received 2500mcg of albuterol. Children weighing more than 20kg, received 2500mcg of albuterol if their presentation met mild severity criteria, or 5000mcg if they met moderate criteria.
干预措施: Breath Actuated Nebulizer (Device)
Albuterol by Metered Dose Inhaler
Albuterol administered via MDI and spacer device with weight and severity based dosing. For weight less than 20 kg: mild and moderate disease 540mcg of albuterol per dose. For weight greater than or equal to 20 kg: mild disease 540 mcg of albuterol per dose and moderate disease 1080 mcg of albuterol per dose.
干预措施: Metered Dose Inhaler (Device)
结局指标
主要结局
Number of Participant's Admitted to the Hospital for Further Treatment
时间窗: 6 hours
Patient disposition is measured as subjects requiring further treatment and being admitted to hospital. We record the number of patients in each cohort that required admission to the hospital after being evaluated and treated in the Emergency Department.
次要结局
- Emergency Department Length of Stay(6 hours)
- Number of Patients With Tachycardia After Treatment(6 hours)
- Number of Patients Requiring Ondansetron Dosing(6 hours)
- Number of Participants Requiring Repeat Visits(Within 7 days of initial presentation)
研究者
Mark Snider
Pediatric Emergency Medicine Fellow
Le Bonheur Children's Hospital