Trial of AccuPAP Device Versus Standard Nebulizer Therapy in Acute Asthma Exacerbation in Children

Currently the standard of care for acute asthma exacerbations in children involves immediate
administration of an inhaled short acting beta agonist (SABA), most commonly Albuterol,
paired with parasympatholytic (Ipratropium) both of which are administered via continuous
nebulizer. Additionally, a course of oral or intravenous systemic corticosteroid such as
methylprednisolone or decadron are also given to combat acute airway inflammation. Medical
providers may also initiate the use of a respiratory support device that can range from
supplemental oxygen delivered via nasal cannula (NC) and escalate to the use of Bi-level
Positive Airway Pressure (BiPAP) or endotracheal intubation in order to increase delivery of
medication to distal airways. Because asthma is the most common chronic disease of childhood,
there have been ongoing studies on many fronts which are being undertaken to minimize
morbidity, shorten hospitalization duration and more rapidly reduce a patient's level of
respiratory distress.

When nebulized medication is delivered to a patient with active bronchospasm it might not be
immediately delivered to the smallest bronchioles and terminal airways which are most
affected by bronchospasm causing air trapping and poor gas exchange. Current modalities rely
on dilation of larger airways first thus allowing medication to diffuse passively to the
smaller airways as dilation occurs down the bronchial tree. Medication delivery is passive
and dependent upon the progressive relaxation of these larger airways before reaching the
smaller airways which is the ultimate goal of nebulized therapies. The critical pressure
required for medication to reach these obstructed airways and keep them stented open is
higher than in an otherwise healthy individual due to the natural consequences of airway
remodeling seen in asthmatics which includes narrowing of the diameter of the airways,
increased atelectasis of hypoventilated areas, and overall increased ventilation-perfusion
(V/Q) mismatch. The concomitant processes of mucous plugging also commonly seen in asthma
further complicates the efficient distribution of these medications in a thoracic cross
section. However, application of positive pressure in patients with obstructive airways
diseases such as asthma has potential to increase air-trapping, dynamic hyperinflation, and
auto-peep and, in turn, aggravate ventilation-perfusion mismatch, all of which has potential
to delay clinical improvement. With these considerations, we seek to determine if the
physiologic benefit of proposed improved bronchodilator delivery by using added positive
airway pressure (ie, active delivery of medication) is of sufficient magnitude to provide
overall benefit to patients with acute asthma exacerbation.

The investigators propose to test this hypothesis through the following aim: To conduct a
single-blinded (clinical team), randomized clinical trial to determine the efficacy of the
AccuPAP device in comparison with the standard nebulizer to decrease acute exacerbation
severity measured with the Acute Asthma Intensity Research Score (AAIRS), an objective and
validated asthma scoring system, at 0, 1 and 2 hours after initiation of treatment. Secondary
outcomes will include Emergency Department (ED) length-of-stay (LOS), general pediatrics
floor hospitalization rate, Pediatric Intensive Care Unit (PICU) admission rate, number of
patients who do not improve with AccuPAP, and rate of relapse within 24 hours of discharge
from the ED. The investigators propose that outcome of the study findings have potential to
not only shorten hospital stay duration which is cost efficient but also decrease the burden
of the disease process on patient by implementing improved medication delivery strategies.

Inclusion Criteria:

- Investigators will enroll children ages 6 - 17 years (inclusive) with a previous
diagnosis of asthma who present in an acute exacerbation to the Pediatric Emergency
Department.

- Patients will be evaluated using the Acute Asthma Intensity Research Score (AAIRS)
which has been validated at Vanderbilt University Medical Center and is currently the
standard of care when triaging patients with asthma.

- An included patient's severity of current exacerbation must be qualified using the
AAIRS and fall in the moderate category of 7 to 11 points.

- Patients who have received nebulized bronchodilator medications at either a referring
facility or at home will be included.

- Patients who present from a referring facility or Primary Care Physician (PCP) and
have received systemic corticosteroids (SCS) within one hour of initial AAIRS scoring
will also be included.

Exclusion Criteria:

- Exclusion criteria will include the following: other medical conditions contributing
to respiratory distress (e.g., pneumonia, cystic fibrosis, anaphylaxis),

- developmental delay or any impedance to following basic AccuPAP use instructions,

- any condition precluding a patient from receiving beta-agonist therapy (ie-
predisposition to Supraventricular Tachycardia).

- Patients with a history of spontaneous pneumothorax, recent facial, oral or skull
surgery/trauma, history of esophageal surgery, known or suspected tympanic membrane
rupture or other middle ear pathology, acute sinusitis, epistaxis, active hemoptysis
or nausea will be excluded as these are contraindications for AccuPAP use.

- Patients who have received additional adjunctive therapies beyond repeated SABA and
atrovent nebulizers or those who have received SCS greater than 1 hour prior to
initial ED evaluation, those who have received intravenous magnesium sulfate infusion,
or subcutaneous terbutaline or epinephrine will be excluded.

- Those patients whose parents are require a translator for consent will also be
excluded (ie, exclusively Spanish speaking or other non-English speaking
families/patients). The justification for this exclusion is that patients with
respiratory distress often need rapid initiation of treatment and the delay that may
be caused by coordination efforts required in order to obtain a translator for study
consent and explanation may delay care for these patients and result in adverse
outcomes that may potentially result in harm.