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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Asthma

Intervention / Treatment
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* Device: T-Piece Nebulizer
* Device: Breath-Enhanced Nebulizer
* Drug: Albuterol
* Procedure: Pre-Treatment Spirometry Measurement
* Procedure: Post-Treatment Spirometry Measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: T-piece Nebulizer<br>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. | Device: T-Piece Nebulizer<br>* Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ)<br>Drug: Albuterol<br>* One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes.<br>* Other names: albuterol sulfate;Procedure: Pre-Treatment Spirometry Measurement<br>* Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer.<br>Procedure: Post-Treatment Spirometry Measurement<br>* Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer.<br>|
| Experimental: Breath-Enhanced Nebulizer<br>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. | Device: Breath-Enhanced Nebulizer<br>* Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA)<br>Drug: Albuterol<br>* One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes.<br>* Other names: albuterol sulfate;Procedure: Pre-Treatment Spirometry Measurement<br>* Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer.<br>Procedure: Post-Treatment Spirometry Measurement<br>* Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FEV1 (% Predicted) | Pre-treatment spirometry measurement assessed at the time of study enrollment. Post-treatment spirometry measurement assessed following the administration of one time 5mg nebulized albuterol sulfate treatment. Assessments taken at baseline (prior to albuterol therapy) and 10 min post-treatment. Change in FEV1 calculated as post-treatment FEV1 minus pre-treatment FEV1 | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PAS Score (Points on a Scale) | Based on examination and auscultation of lungs prior to and immediately following albuterol administration. PAS score is on a scale of 0-10 which is a sum of five separate sub-scores each on a scale of 0-2. The five sub-scores are: Respiratory rate (6-12yr/>12yr): <=26/23 (0), 27-30/24-27 (1), >31/28 (2) Oxygenation: >95% (0), 90-95 (1), <90 (2) Auscultation: clear/end expiratory wheeze (0), expiratory wheeze (1), biphasic wheeze/diminished (2) Work of Breathing (accessory muscles): <= 1 (0), 2 (1), >=3 (2) Dyspnea: Full sentences (0), Partial sentences (1), Single words (2) Pre-treatment assessment at the time of study enrollment. Post-treatment assessment following the administration of one time 5mg nebulized albuterol sulfate treatment. Assessments taken at baseline (prior to albuterol therapy) and 10 min post-treatment. Change in PAS calculated as post-treatment PAS minus pre-treatment PAS. | 10 minutes | 
| Change in PASS Score (Points on a Scale) | Determined by examination and auscultation of lungs to prior to and immediately following albuterol administration. PASS is a total score on a scale of 0-6 which is calculated as a sum of three sub-scores, each on a scale of 0-2. The sub-scores are: Wheezing: None or Mild (0), Moderate (1), Severe wheezing or absent wheezing due to poor air exchange (2) Work of breathing (accessory muscle use or retractions): None or mild (0), Moderate (1), Severe (2) Prolonged expiration: Normal or mildly prolonged (0), moderately prolonged (1), severely prolonged (2) Pre-treatment assessment at the time of study enrollment. Post-treatment assessment following the administration of one time 5mg nebulized albuterol sulfate treatment. Assessments taken at baseline (prior to albuterol therapy) and 10 min post-treatment. Change in PASS calculated as post-treatment PASS minus pre-treatment PASS. | 10 minutes | 
| Percentage of Patients Requiring Inpatient Hospital Admission (% of Subjects) | Admission rate to inpatient hospital will be assessed at the time of Emergency Department disposition which will be approximately 3 hours, but will be assessed up to 24 hours depending on duration of ED stay. | Up to 24 hours | 
| Emergency Department Length of Stay (Minutes) | Total length of stay will be assessed at the time of Emergency Department disposition which will be approximately 3 hours, but will be assessed up to 24 hours depending on duration of ED stay. | Up to 24 hours | 
| Percentage of Patients Experiencing Medication Side Effects (%) | Subjects and parents/guardians will be asked whether subjects experienced nausea, vomiting, palpitations, headache, dizziness either during (assessed by non-blinded personnel) or following treatment (assessed by blinded personnel during post-treatment assessment). Subject and parent/guardian will also be asked if any other side effects were experienced. | 10 minutes | 
| Total Quantity of Albuterol Given in the Emergency Department (mg) | Cumulative dose of albuterol in mg will be assessed at the time of Emergency Department disposition which will be approximately 3 hours, but will be assessed up to 24 hours depending on duration of ED stay. | up to 24 hours | 
| Change Respiratory Rate (Breaths Per Minute) | Respiratory rate will be measured by observation and auscultation over 30 seconds prior to and immediately following albuterol administration Pre-treatment assessment at the time of study enrollment. Post-treatment assessment following the administration of one time 5mg nebulized albuterol sulfate treatment. Assessments taken at baseline (prior to albuterol therapy) and 10 min post-treatment. Change in respiratory rate calculated as post-treatment respiratory rate minus pre-treatment respiratory rate. | 10 minutes | 
| Change in Heart Rate (Beats Per Minute) | Blinded research personnel will assess subject's heart rate by auscultation and/or pulse palpation prior to and immediately following albuterol administration. Pre-treatment assessment at the time of study enrollment. Post-treatment assessment following the administration of one time 5mg nebulized albuterol sulfate treatment. Assessments taken at baseline (prior to albuterol therapy) and 10 min post-treatment. Change in heart rate calculated as post-treatment heart rate minus pre-treatment heart rate. | 10 minutes |