Peak Expiratory Flow Rate for Emergency Department Management of Acute Asthma Exacerbation
Condition: Asthma
MeSH terms: Asthma; Emergencies
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      At 150 minutes, it is expected that approximately 80% of patients will have no or mild asthma
      symptoms in both groups. When comparing the proportion of patients between the two groups, a
      confidence interval less than 20% wide (10% on either side of the point estimate) is desired.
      Therefore, goal enrollment is 110 patients per group.

      This study will only include patients who are discharged from the ED. Patients who are
      enrolled and then eventually admitted to the hospital will be tabulated but excluded from the
      analysis.

      Statistical analysis will compare the difference in the proportion of patients who achieve
      the primary outcome between groups, with the associated 95% confidence interval. Secondary
      outcomes will be presented descriptively; depending on the final distribution of the data,
      the investigators will present the means or medians of the data with the associated
      difference in mean/median with the associated 95% confidence intervals
    

Intervention name(s): Peak Expiratory Flow Rate (PEFR); Standard Clinical Judgement
Intervention type(s): Other; Other
Intervention description(s): PEFR values and the National Asthma Prevention and Education Program guidelines will be used by providers in the management of these patients.; Providers will use physical exam and standard clinical judgement to guide management.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment