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

• Status: Withdrawn
• Trial end date: 2020-11-11
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this randomized control trial is to investigate the efficacy of an adjunct positive airway pressure (PAP) nebulizer device known as "AccuPAP" in the treatment of moderate-severity acute asthma exacerbations in children ages 6 - 17 years in comparison with an institutional standard continuous dual-therapy nebulizer treatment.

The investigators main goal, more specifically, is to determine if the additional positive airway pressure provided by the AccuPAP device when used in treating children with moderate-severity asthma exacerbations provides a more optimal delivery of bronchodilator therapy when compared to institutional standard protocol nebulizer delivery mask which does not employ the use of positive airway pressure in medication delivery. The investigators have determined that the change in a study-validated Acute Asthma Intensity Research Score (AAIRS) which will be considered statistically significant for a patient is 2 points or greater after the first treatment has been completed.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Treatments: Albuterol; Ipratropium

Criteria

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.