Effectiveness and Costs of Albuterol Delivered by MDI With Spacer Versus Nebulizer in Children Hospitalized With Moderate and Severe Asthma Exacerbations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Change in Clinical Asthma Severity score over time
研究概览
简要总结
This study will be conducted as a randomized, double blinded, controlled trial. The control group will receive albuterol delivered by a nebulizer along with placebo treatments delivered by a metered dose inhaler (MDI) with a spacer +/- mask. The experimental group will receive albuterol delivered by MDI with spacer +/- mask along with placebo treatments given by a nebulizer. Parents, participants, study personnel, nursing staff, and respiratory therapists will not know the treatment assignments of participants. The primary outcome will be changes over time in an asthma severity score, the Clinical Asthma Score (CAS) (Parkin et al. 1996). The secondary outcomes will be total number of albuterol treatments received in the hospital, time it take to give treatments, time till subjects' albuterol treatments are given at four hour intervals, and the costs of the two types of treatments. The study hypothesis is that albuterol delivered by metered dose inhaler with spacer is non-inferior to albuterol delivered by nebulizer in the treatment of children hospitalized with moderate to severe asthma exacerbations.
详细描述
Studies looking at the use of beta-2-agonists given by MDIs with a spacer and mask in children greater than 2 years have described fewer side effects than when the same medications are given as nebulizers. Patients have less tachycardia, vomiting, and oxygen desaturation (Kerem et al. 1993, Chou, Cunningham and Crain 1995, Lin and Hsieh 1995, Pendergast et al. 1989, Fuglsang and Pedersen 1986).
In the emergency department setting, Rubilar et. al found that albuterol delivered by MDI with spacer and mask had equal efficacy to albuterol delivered by a nebulizer in treating acute wheezing in children less than 2 years of age. (Rubilar, Castro-Rodriguez and Girardi 2000) Chou et. al found that in children greater than 2 years old with acute asthma exacerbations, MDIs had the same efficacy as nebulizers but with a shorter delivery time and fewer side effects.(Chou et al. 1995)
All children who meet criteria to be participants in the study will be approached for possible study enrollment in the ED. No outside recruiting will be done. Once consent has been obtained and patients are enrolled, they will be randomized to either albuterol by MDI with placebo nebulizer treatments or albuterol by nebulizer with placebo MDI treatments. Subjects will be randomized to one of the two treatment arms in a 1:1 randomization process. This will be done using a prepared assignment log developed using a random number generator.
Children in the control arm will receive albuterol via nebulizer and placebo by MDI with spacer +/- mask. Children in the experimental arm will receive albuterol by MDI and placebo by nebulizer.
All MDI treatments will be given with a spacer +/- mask. Subjects will receive 6 puffs if they are < 30 kg and 10 puffs if they are > 30 kg. If they are in the control group, puffs will be placebo. If they are in the experimental group, puffs will be albuterol (90 micrograms per puff).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 1 to 18 years of age with a known history of asthma being admitted to Akron Children's Hospital general medical floor for the treatment of moderate to severe asthma exacerbations
排除标准
- •Children who have a concurrent pneumonia or bronchiolitis (diagnosed clinically or by chest x-ray)
- •Have a diagnosis of chronic lung disease (ex. cystic fibrosis, bronchopulmonary dysplasia, chronic aspiration)
- •Have cyanotic congenital heart disease, a congenital anomaly of the respiratory tract, or who are tracheostomy or ventilator dependent.
- •Children who are determined by the Emergency Department (ED) or general pediatrics service to need ICU level care on admission will also be excluded.
- •Children will also be excluded if their legal guardian does not speak English as all consent forms will be written and reviewed with guardians in English.
- •Children will also be excluded if their legal guardians disagree on consent to participate, or if a child 9 years or older and their legal guardians disagree on study participation.
结局指标
主要结局
Change in Clinical Asthma Severity score over time
时间窗: 72 hours
次要结局
- Time to discharge(Total time in the hospital)
- Time to when are able to go 4 hours between albuterol treatments(Time in hospital)
- Cost of delivering albuterol by MDI versus nebulizer(Time in hospital)