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

Seton Healthcare Family

Status: Completed

Conditions: Asthma

Treatments: Procedure: Post-Treatment Spirometry Measurement; Procedure: Pre-Treatment Spirometry Measurement; Drug: Albuterol; Device: T-Piece Nebulizer; Device: Breath-Enhanced Nebulizer

Study type: Interventional

Funder types: Other

Identifiers

NCT02566902

CR-15-047

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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118 participants in 2 patient groups

T-piece Nebulizer

Active Comparator group

Description:

Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "T-piece Nebulizer" (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.

Treatment:

Device: T-Piece Nebulizer

Procedure: Pre-Treatment Spirometry Measurement

Procedure: Post-Treatment Spirometry Measurement

Drug: Albuterol

Breath-Enhanced Nebulizer

Experimental group

Description:

Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "Breath-Enhanced Nebulizer" (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.

Treatment:

Procedure: Pre-Treatment Spirometry Measurement

Procedure: Post-Treatment Spirometry Measurement

Device: Breath-Enhanced Nebulizer

Drug: Albuterol