Comparison of Nebulizers in ED in Pediatric Asthma Patients

NCT01951378 | Terminated Phase 4 Results DMC

• 1 other identifier: CR-13-119
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective will be, in an open-label randomized trial, a comparison of emergency department (ED) length of stay (LOS) between children experiencing acute asthma treated with two different nebulizers. Secondary outcomes will include admission rates, hospital LOS, need for additional therapies, transfers to a higher level of care, side-effects, and unscheduled return visits

Conditions

Asthma

Keywords

Asthma; Asthma exacerbation

Outcome Measures

Primary Outcomes (1)

• The Primary Objective Will be, in an Open-label Randomized Trial, a Comparison of Emergency Department (ED) Length of Stay (LOS) Between Children Experiencing Acute Asthma Treated With Two Different Nebulizers

  The primary endpoint will be mean ED LOS difference between the groups. Using historical data as a guide, we calculated a baseline LOS mean for discharged patients of 181 minutes, and standard deviation (SD) of 83 minutes. For this reason, an interim analysis will be conducted in order to assess a pilot sample for the purpose of estimating these values. 25 subjects in each arm (50 subjects total) will be enrolled during the initial phase of the study. This early phase interim analysis is not powered to test for differences between the groups, but establish pilot-phase findings that can be used for more accurate sample size calculation. However, the primary outcome of ED LOS will then be tested to determine the difference between study arms, using the non-parametric Mann-Whitney U test due to the likely skewed-nature of the distribution of ED LOS values for the purpose of establishing an estimate of effect size in the initial enrollment phase.

  1 year

Secondary Outcomes (1)

• to Evaluate Admission Rates.

  1 year

Other Outcomes (4)

• Will Evaluate Hospital LOS. Safety Issue?: (FDAAA) No

  1 year

• Will Evaluate Need for Additional Therapies.

  1 year

• Will Evaluate Transfers to a Higher Level of Care.

  1 year

Study Arms (2)

Hudson RCI® nebulizer

ACTIVE COMPARATOR

Patients randomized to the "standard" arm will receive treatments as dictated by our standard ED asthma pathway (Fig. 1). All treatments will be administered with our standard ED nebulizer, the Hudson RCI® Up-Draft® Neb-U-Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ), and a simple mask (Hudson RCI®, Teleflex Medical®, Research Triangle Park, NJ).

Device: Hudson RCI® nebulizer; Drug: Albuterol

NebuTech® HDN® nebulizer

ACTIVE COMPARATOR

Patients randomized to the "NebuTech®" arm will receive treatments as dictated by our trial pathway, referred to as the "rapid Albuterol/Proventil delivery pathway" (Fig. 2). All nebulizations in this arm will be administered via the Breath-Enhanced High Density Jet Nebulizer, NebuTech® HighDensityNebulizer®,(Salter Labs®, Arvin, CA). Respiratory Therapists (RT) will attempt to deliver all treatments with a mouthpiece, as that has been shown to be the most efficient and reliable mode of aerosol delivery for most children 31, 32. If the Respiratory Therapist feels that the child will not or cannot effectively use a mouthpiece, a mask will be used.

Device: NebuTech® HDN® nebulizer; Drug: Albuterol

Interventions

Hudson RCI® nebulizer DEVICE

After the first hour of treatment, patients in the standard arm will receive a repeat assessment, including all of the measurements collected at baseline as well as reported side effects. Those patients who score PAS 0-2 will then be discharged home, after an optional observation period, as per the pathway. Those who score PAS \> 2 will receive a second treatment. At the end of the second treatment patients will again be re-assessed, and repeat measurements obtained. At that time, depending on the patient's PAS score, he/she will be dispositioned to home, the floor, the pulmonary high acuity unit (PHAU), or the pediatric intensive care unit (PICU).

Hudson RCI® nebulizer

NebuTech® HDN® nebulizer DEVICE

All treatments in the NebuTech® arm will be given at a standard dilution of 5 ml (diluted with normal saline to a total volume of 5 ml as per the manufacturer's recommendation). Patients in this arm will receive up to four treatments with parameters measured after each treatment, similar to the control arm. Patients who complete four treatments will then be dispositioned based on PAS score, similar to the control arm. Subjects may have started treatment prior to consent and may receives unit dose (2.5 mg) Albuterol/Proventil treatments will be given with a standard nebulizer up to 3 times as needed and may change over to study randomized device once consented to eith arm.

NebuTech® HDN® nebulizer

Albuterol DRUG

Subjects may have started treatment prior to consent and may receives unit dose (2.5 mg) Albuterol/Proventil treatments will be given with a standard nebulizer up to 3 times as needed and may change over to study randomized device once consented to eith arm.

Also known as: Proventil

Hudson RCI® nebulizer; NebuTech® HDN® nebulizer

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age ≥ 3 years and \< 18 years
• History of physician-diagnosed asthma
• Presenting to ED with acute asthma exacerbation according to attending physician

You may not qualify if:

• PAS score \< 3
• Immediate resuscitation required
• Chronic lung disease (other than asthma)
• Congenital heart disease 5. Neuromuscular disease 6. Suspected intrathoracic foreign body 7. Is or may be pregnant 8. Currently breast feeding 9. Oral or parenteral steroids within the last 7 days 10. Allergy or other contraindication to any of the study medications

Sponsors & Collaborators

• Seton Healthcare Family: lead

Study Sites (1)

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Director Pediatric Fellowship
• Organization: Seton Family of Hospital

a.a@abc.com

512-324-9999

Study Officials

• Matthew H. Wilkinson, MD

  Seton Healthcare Family

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: September 26, 2013
• Study Start: September 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: April 8, 2021
• Results First Posted: September 2, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)