NCT02566902

Comparison of Breath-Enhanced and T-Piece Nebulizers in Children With Acute Asthma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Seton Healthcare Family · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DEVICE	T-Piece Nebulizer	Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ)
DEVICE	Breath-Enhanced Nebulizer	Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA)
DRUG	Albuterol	One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes.
PROCEDURE	Pre-Treatment Spirometry Measurement	Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer.
PROCEDURE	Post-Treatment Spirometry Measurement	Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer.

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-06-30
• Completion: 2017-06-30
• First posted: 2015-10-02
• Last updated: 2021-05-06
• Results posted: 2021-05-06

Locations

1 site across 1 country: United States