Bilevel Positive Airway Pressure (BPAP) for Severe Asthma

Prior treatment

• Prior participation in the study.
• Use of BPAP at any time within approximately 12 hours for this acute asthma exacerbation, including in prehospital, ED, or inpatient settings, prior to randomization.
• Receipt of continuous albuterol for over 150 minutes prior to being approached for consent.
• If a blood gas is obtained, PaCO2 greater than 60 mmHg on the most recent blood gas prior to being approached for consent.
  • Note: Blood gas values are not required for eligibility confirmation.
• Anticipated immediate need (i.e., within approximately an hour after completion of first-line therapy) for invasive mechanical ventilation (e.g., endotracheal tube or laryngeal mask airway) or non-invasive mechanical ventilation (e.g., continuous positive airway pressure (CPAP) or BPAP), as determined by the treating physician.
• Absolute or relative contraindication to BPAP, defined as any of the following:
  • Facial trauma within the area where the face mask would be applied for BPAP (excluding minor abrasion or cuts on forehead or skull).
  • Uncontrollable vomiting (i.e., \> 3 episodes within approximately 1 hour prior to being approached for consent).
  • Hypotension for age, defined as systolic blood pressure (SBP) less than 70 plus twice the patient's age in years (i.e., SBP \< 70 + \[2 x age in years\]).
  • Glasgow Coma Score of 8 or less.
  • Known or clinical suspicion for air leak syndrome (e.g., pneumothorax, pneumomediastinum, pneumopericardium, or subcutaneous emphysema).
• PRAM score less than 7 or greater than 10 based on concurrent clinical assessment by a healthcare provider after completion of standard first-line therapies, which is defined as receiving all of the following prior to ED arrival or during the ED encounter for this acute asthma exacerbation:
  • Albuterol with or without ipratropium bromide, either at least 3 albuterol doses via inhalation method (e.g., metered-dose inhaler (MDI) or nebulized) or at least one hour of continuous albuterol (i.e., continuous nebulized albuterol or three consecutive intermittent nebulized albuterol treatments as bridging therapy).
  • Corticosteroids (e.g., Prednisolone, Prednisone, Dexamethasone/Decadron, or Methylprednisolone) via enteral, intravenous, or intramuscular methods.
  • Note: Oxygen is not a required first-line therapy.
• Do not require continuous albuterol or a second round of albuterol treatments (e.g., three back-to-back treatments or one hour of burst albuterol treatment) following completion of standard first-line therapies.

Other illness

• Wheezing due to non-asthma causes (e.g., foreign body, tracheomalacia, vocal cord dysfunction, pulmonary edema, uncorrected congenital heart disease, cystic fibrosis, or anaphylaxis).
• Any medical condition that, in the opinion of a site investigator, could 1) lead to difficulty complying with protocol procedures, 2) interfere with the safe completion of the study, or 3) affect the validity of the endpoint assessments.

Other

• Presence of a tracheostomy or a baseline requirement for noninvasive ventilation.
• Weight \< 20 kg.
• Presence of an intra-abdominal mass compressing the stomach (e.g., due to tumor or large volume ascites) through EMR or medical history.
• Known or suspected pregnancy by history or if pregnancy test completed by clinical team.

• 5 to 17 years of age (inclusive) presenting to the ED with an asthma exacerbation.
• Demonstrate moderate-severe asthma exacerbation at triage (i.e., receive an institutional asthma score equivalent to moderate-severe asthma exacerbation or a Pediatric Respiratory Assessment Measure (PRAM) score of 6 or above).