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

April 13, 2021 updated by: Seton Healthcare Family
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78723
        • Dell Children's Medical Center, Emergency Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: T-piece Nebulizer
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
Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ)
Drug: Albuterol
One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes.
Other Names:
  • albuterol sulfate
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.
EXPERIMENTAL: Breath-Enhanced Nebulizer
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.
Drug: Albuterol
One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes.
Other Names:
  • albuterol sulfate
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.
Device: Breath-Enhanced Nebulizer
Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in FEV1 (% Predicted)
Time Frame: 10 minutes
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)
Time Frame: 10 minutes

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:

  1. Respiratory rate (6-12yr/>12yr): <=26/23 (0), 27-30/24-27 (1), >31/28 (2)
  2. Oxygenation: >95% (0), 90-95 (1), <90 (2)
  3. Auscultation: clear/end expiratory wheeze (0), expiratory wheeze (1), biphasic wheeze/diminished (2)
  4. Work of Breathing (accessory muscles): <= 1 (0), 2 (1), >=3 (2)
  5. 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)
Time Frame: 10 minutes

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:

  1. Wheezing: None or Mild (0), Moderate (1), Severe wheezing or absent wheezing due to poor air exchange (2)
  2. Work of breathing (accessory muscle use or retractions): None or mild (0), Moderate (1), Severe (2)
  3. 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)
Time Frame: Up to 24 hours
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)
Time Frame: Up to 24 hours
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 (%)
Time Frame: 10 minutes
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)
Time Frame: up to 24 hours
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)
Time Frame: 10 minutes

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)
Time Frame: 10 minutes

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seton Healthcare Family

Collaborators

University of Texas

Investigators

  • Principal Investigator: Matthew Wilkinson, MD, Seton Healthcare Family

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ACTUAL)

June 30, 2017

Study Completion (ACTUAL)

June 30, 2017

Study Registration Dates

First Submitted

September 24, 2015

First Submitted That Met QC Criteria

September 30, 2015

First Posted (ESTIMATE)

October 2, 2015

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2021

Last Update Submitted That Met QC Criteria

April 13, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-15-047

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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