Positive Expiratory Pressure for the Treatment of Acute Asthma Exacerbations in Children: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in Pulmonary Asthma Score (PAS)
研究概览
简要总结
Asthma is a leading cause of emergency department (ED) visits for children. A novel way of treating asthma is the use of positive expiratory pressure (PEP). Positive expiratory pressure works by creating pressure in the lungs to keep airways open and to clear mucus from the lungs. PEP is already used in the treatment of asthma at the investigators institution, but studies evaluating the efficacy of PEP therapy in asthma exacerbations do not exist. This study plans to learn more about the use of PEP therapy in the treatment of asthma exacerbations in children in the emergency department. Specifically, the study aims to evaluate if PEP therapy reduces the severity of asthma exacerbations in children and if it reduces the need for additional therapies and admission to the hospital. This study will be a randomized control trial comparing children who receive standard therapy to those who receive standard therapy plus PEP therapy in the treatment of asthma exacerbations. Children age 2 to 18 years presenting to the ED with moderate to severe asthma exacerbations will be included in the study. Reduction in clinical asthma severity will be measured by change in the Pulmonary Asthma Score (the respiratory severity score used at the investigators institution). The need for additional therapies and hospitalization will also be evaluated.
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
- Single (Outcomes Assessor)
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
- •Age >= 2 and < 18 years of age
- •Established diagnosis of asthma, defined as at least two prior episodes of treatment with bronchodilators in their lifetime
- •Initial ED presentation with a moderate to severe asthma exacerbation, as defined by a pulmonary asthma score (PAS) >7
- •PAS score >7 and <12 after completion of first line therapies (three doses albuterol/ipratropium bromide and oral corticosteroids)
排除标准
- •Do not receive complete first line therapies
- •Immediately receive a disposition (admission or discharge) as determined by the treating clinician after completion of first line therapies
- •Receive prednisone or more than two doses of inhaled bronchodilators prior to main ED evaluation (e.g. during EMS transport or primary care visit)
- •Co-morbid illnesses interfering with or contraindicated to usual asthma therapy (e.g. facial or airway abnormalities, pneumonia, chronic lung disease, congenital heart disease, cystic fibrosis, or pneumothorax)
- •Critically ill at presentation
- •Pregnant women (women known to be pregnant at the time of enrollment)
研究组 & 干预措施
EzPAP
Patients randomized to the EzPAP arm will receive first-line therapies and PEP therapy via EzPAP. All patients will receive 4 cycles with 12 breaths per cycle. 4 cycles is considered one time administration.
干预措施: EzPAP (Drug)
Standard care
Patients randomized to the control arm will receive first-line therapies and standard therapy.
干预措施: Standard Care (Other)
结局指标
主要结局
Change in Pulmonary Asthma Score (PAS)
时间窗: 0-30 minutes
The primary outcome was the change in asthma severity as determined by change in Pulmonary Asthma Score (PAS) before and after administration of intervention (or control). The same trained, blinded physician assessor, who was not involved in the care of the patient, assessed PAS scores for study subjects before intervention (or control), and 15 minutes after completion of administration. The PAS is a pediatric asthma severity scoring system adapted from previously validated scores, and includes measures of respiratory rate, oxygen saturation, auscultory findings, retractions, and dyspnea. Values from each category are summed producing a total score between 5 and 15. Total scores \< 7 correspond with mild asthma exacerbations, while scores ≥ 7 and \< 12 indicate moderate asthma, and scores ≥12 to 15 indicate severe asthma. The primary outcome was determined by subtracting the post-intervention score from the pre-intervention score.
次要结局
- Rate of Inpatient Hospitalization(After intervention or control and until follow-up phone call 72 hours after disposition)
- Number of Participants Requiring Second Line Therapies Including Continuous Albuterol, Subcutaneous Terbutaline, IV Magnesium and Supplemental Oxygen After Administration of Intervention or Control(participants will be followed for the duration of ED stay, an expected average of 6-8 hours)