Comparison of Breath-Enhanced and T-Piece Nebulizers in Children With Acute Asthma
| Status: | Recruiting |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 6 - 17 |
| Updated: | 4/27/2017 |
| Start Date: | October 2015 |
| End Date: | June 2017 |
| Contact: | Michael Gardiner, MD |
| Email: | mgardiner2@seton.org |
| Phone: | 5123240093 |
This is a blinded observer randomized controlled trial comparing two nebulizer devices. The
objective of this study is to evaluate the efficacy of two different nebulizers.
objective of this study is to evaluate the efficacy of two different nebulizers.
The investigators hypothesize that albuterol delivered with a breath-enhanced nebulizer will
lead to statistically greater improvement in FEV1 when compared to an equivalent dose
delivered via a standard t-piece nebulizer. The primary aim will be to study changes in
forced expiratory volume in one second (FEV1) in patients presenting to an urban pediatric
emergency department with a moderate to severe acute asthma exacerbation when utilizing
these two nebulizers. Secondary aims will include evaluation of hospital admission rates,
emergency department (ED) length of stay (LOS), changes in asthma severity scores, vital
sign changes, medication side effects, and total quantity of albuterol given in the ED. A
distal aim of the study will be to perform a cost analysis; though the investigators will
likely need further clinical trials utilizing multiple dose administration in order to
accurately analyze cost.
lead to statistically greater improvement in FEV1 when compared to an equivalent dose
delivered via a standard t-piece nebulizer. The primary aim will be to study changes in
forced expiratory volume in one second (FEV1) in patients presenting to an urban pediatric
emergency department with a moderate to severe acute asthma exacerbation when utilizing
these two nebulizers. Secondary aims will include evaluation of hospital admission rates,
emergency department (ED) length of stay (LOS), changes in asthma severity scores, vital
sign changes, medication side effects, and total quantity of albuterol given in the ED. A
distal aim of the study will be to perform a cost analysis; though the investigators will
likely need further clinical trials utilizing multiple dose administration in order to
accurately analyze cost.
Inclusion Criteria:
- Age ≥ 6 years and < 18 years
- History of physician diagnosed asthma
- Presenting to ED with breathing difficulty or cough
- Initial FEV1 25%-70% predicted
- Parent or guardian speaks English or Spanish.
Exclusion Criteria:
- Pediatric Asthma Score of 0
- Pregnancy or breast-feeding
- Immediate resuscitation required
- Chronic lung disease (other than asthma)
- Congenital heart disease
- Neuromuscular disease
- Suspected intrathoracic foreign body
- Allergy or other contraindication to study medication
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