Peak Expiratory Flow Rate (PEFR) for Emergency Department Management of Acute Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- Adequate control of asthma symptoms within 150 minutes
研究概览
简要总结
Patients presenting to the emergency department with acute asthma exacerbation will be assigned to peak-expiratory flow rate (PEFR) guided management and non-PEFR guided management.
详细描述
It is common practice to use peak-expiratory flow rate (PEFR) as an indicator of severity in patients that present with acute asthma exacerbation. There is, however, little data supporting this practice.
A recent Canadian 20 site prospective observational cohort study of 805 ED patients with acute asthma exacerbation concluded PEFR was not useful in predicting need for hospitalization or relapse following discharge.
As this was a cohort observational study, the conclusions that can be drawn are limited by the lack of randomization and control; it is necessary to conduct a randomized controlled trial to quantify how much time is expended caring for these patients, and gather safety data.
This is important because no studies have quantified differences in resource utilization based on PEFR-guided management compared to non-PEFR-guided management. It is possible physicians following PEFR-guided management use comparatively more resources, such as nebulizer treatments and hospitalization, in order to treat low PEFR values in patients they would have otherwise discharged based on clinical judgement alone. If outcomes are not affected by non-PEFR-guided management, it may reduce resource utilization to avoid using PEFR-guided management.
The investigators seek to determine if PEFR-based management and non-PEFR-based management perform similarly in guiding ED management of acute asthma exacerbations. Specifically, they seek to determine if the proportion of patients with no or mild asthma symptoms at 150 minutes after enrollment arrival is similar in the two groups.
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 (Care Provider)
盲法说明
When patients are randomized to the non-peak flow guided therapy, physicians are blinded to the peak flow values
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presumed diagnosis of asthma, requiring at least 2 nebulized albuterol treatments
- •Presenting with acute asthma exacerbation defined as acute or subacute episodes of progressively worsening shortness of breath, cough, wheezing, and chest tightness, or some combination of these symptoms
- •Start of enrollment process must occur within 15 minutes of being roomed in the ED
- •Working phone number and willingness to be contacted at least 72 hours following encounter
排除标准
- •Prisoner or in custody
- •Known diagnosis of COPD
- •Co-morbid medical conditions that patient is seeking treatment for concurrently
- •Non-English speaking
- •Unable to provide informed consent
- •In the resuscitation bay or on non-invasive positive pressure ventilation (NPPV)
结局指标
主要结局
Adequate control of asthma symptoms within 150 minutes
时间窗: 150 minutes
Proportion of patients reporting no or mild asthma symptoms at 150 minutes after enrollment
次要结局
- ED Length of Stay(12 hours)
- Hospitalization during index encounter(12 hours)
- Relapse following discharge within 72 hours(72 hours)
- Number of nebulized treatments with short-acting beta antagonists (SABA)(12 hours)
研究者
Brian Driver
Director of Clinical Research
Hennepin Healthcare Research Institute