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

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ClinicalTrials.gov Identifier: NCT02566902
Recruitment Status : Completed
First Posted : October 2, 2015
Results First Posted : May 6, 2021
Last Update Posted : May 6, 2021
Sponsor:
Collaborator:
University of Texas
Information provided by (Responsible Party):
Seton Healthcare Family

Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Device: T-Piece Nebulizer Device: Breath-Enhanced Nebulizer Drug: Albuterol Procedure: Pre-Treatment Spirometry Measurement Procedure: Post-Treatment Spirometry Measurement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Breath-Enhanced and T-Piece Nebulizers in Children With Acute Asthma
Study Start Date : October 2015
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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 Name: 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.
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.
Other Name: 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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


  8. 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.




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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02566902


Locations
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United States, Texas
Dell Children's Medical Center, Emergency Department
Austin, Texas, United States, 78723
Sponsors and Collaborators
Seton Healthcare Family
University of Texas
Investigators
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Principal Investigator: Matthew Wilkinson, MD Seton Healthcare Family
  Study Documents (Full-Text)

Documents provided by Seton Healthcare Family:
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seton Healthcare Family
ClinicalTrials.gov Identifier: NCT02566902    
Other Study ID Numbers: CR-15-047
First Posted: October 2, 2015    Key Record Dates
Results First Posted: May 6, 2021
Last Update Posted: May 6, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action