Trial of AccuPAP Device Versus Standard Nebulizer Therapy in Acute Asthma Exacerbation in Children
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.
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This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Nov 13, 2020 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Vanderbilt University Medical Center
- Interventions being studied
- Device: AccuPAP; Drug: Albuterol and Ipratropium Continuous Nebulizer
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Vanderbilt University Medical Center Monroe Carell Jr. Childrens Hospital Pediatric Emergency DepartmentNashville, Tennessee
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 13, 2020. Always confirm current availability with the study team.