Trial of AccuPAP Device Versus Standard Nebulizer Therapy in Acute Asthma Exacerbation in Children
Status:
Withdrawn
Trial end date:
2020-11-11
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Vanderbilt University Vanderbilt University Medical Center