Positive Expiratory Pressure for the Treatment of Acute Asthma in Children
Condition: Asthma
MeSH terms: Asthma
Intervention: EzPAP; Standard Care
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 52.0
Sex: All
Minimum age: 2 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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)

        Exclusion Criteria:

          -  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)