Trial of AccuPAP Device Versus Standard Nebulizer Therapy in Acute Asthma Exacerbation in Children

NCT02458482 | Withdrawn DMC

• 1 other identifier: 150070
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this randomized control trial is to investigate the efficacy of an adjunct positive airway pressure (PAP) nebulizer device known as "AccuPAP" in the treatment of moderate-severity acute asthma exacerbations in children ages 6 - 17 years in comparison with an institutional standard continuous dual-therapy nebulizer treatment. The investigators main goal, more specifically, is to determine if the additional positive airway pressure provided by the AccuPAP device when used in treating children with moderate-severity asthma exacerbations provides a more optimal delivery of bronchodilator therapy when compared to institutional standard protocol nebulizer delivery mask which does not employ the use of positive airway pressure in medication delivery. The investigators have determined that the change in a study-validated Acute Asthma Intensity Research Score (AAIRS) which will be considered statistically significant for a patient is 2 points or greater after the first treatment has been completed.

Conditions

Asthma

Keywords

Children; Positive Airway Pressure; Nebulizer; Moderate; Acute; AccuPAP

Outcome Measures

Primary Outcomes (1)

• Change in Acute Asthma Intensity Research Score (AAIRS)

  A validated asthma scoring system at Vanderbilt University Medical Center used to determine the severity of acute asthma exacerbation

  From Initial AAIRS scoring in Triage until the end of hour 1 and 2 of treatment during study enrollment

Secondary Outcomes (5)

• Length of Stay (LOS)

  To be determined at the time of patient disposition, usually occuring on average between hours 2 and 4 of emergency department evaluation.

• Rate of Admission to the General Pediatrics Floor

  Within 24 hours of study enrollment

• Rate of Admission to the Pediatric Intensive Care Unit (PICU)

  Within 24 hours of study enrollment

• Number of Patients Who Do Not Show Improvement on AccuPAP After the First Hour of Treatment

  Within 2 hours of study enrollment

• Rate of Relapse

  Within 24 Hours of Discharge form the Pediatric Emergency Department

Study Arms (2)

Standard Nebulizer Mask Group

ACTIVE COMPARATOR

Patients randomized to this "Control" or "standard therapy" group are to receive current institutional standard therapy for moderate asthma exacerbation which includes 10 mg Albuterol combined with 1.5mg Ipratropium nebulized therapy over one hour.

Drug: Albuterol and Ipratropium Continuous Nebulizer

AccuPAP Group

EXPERIMENTAL

Patients randomized to this group must also have moderate asthma exacerbation and will use an investigational device called "AccuPAP" to receive three allotments of Albuterol and Ipratropium in nebulized form.

Device: AccuPAP

Interventions

AccuPAP DEVICE

The AccuPAP device used by participants will give 2.5mg and 0.5mg nebulized Albuterol and Ipratropium over 5 minutes. Inspiratory and expiratory pressures to be set at 6 and 12 cm H20 respectively. This therapy is repeated at 20 and 40 minutes for a total of three AccuPAP treatments.

AccuPAP Group

Albuterol and Ipratropium Continuous Nebulizer DRUG

10mg Albuterol and 1.5mg Ipratropium continuous nebulizer treatment will be administered to a Control group over a one hour period.

Also known as: Duoneb treatment

Standard Nebulizer Mask Group

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Investigators will enroll children ages 6 - 17 years (inclusive) with a previous diagnosis of asthma who present in an acute exacerbation to the Pediatric Emergency Department.
• Patients will be evaluated using the Acute Asthma Intensity Research Score (AAIRS) which has been validated at Vanderbilt University Medical Center and is currently the standard of care when triaging patients with asthma.
• An included patient's severity of current exacerbation must be qualified using the AAIRS and fall in the moderate category of 7 to 11 points.
• Patients who have received nebulized bronchodilator medications at either a referring facility or at home will be included.
• Patients who present from a referring facility or Primary Care Physician (PCP) and have received systemic corticosteroids (SCS) within one hour of initial AAIRS scoring will also be included.

You may not qualify if:

• developmental delay or any impedance to following basic AccuPAP use instructions,
• any condition precluding a patient from receiving beta-agonist therapy (ie- predisposition to Supraventricular Tachycardia).
• Patients with a history of spontaneous pneumothorax, recent facial, oral or skull surgery/trauma, history of esophageal surgery, known or suspected tympanic membrane rupture or other middle ear pathology, acute sinusitis, epistaxis, active hemoptysis or nausea will be excluded as these are contraindications for AccuPAP use.
• Patients who have received additional adjunctive therapies beyond repeated SABA and atrovent nebulizers or those who have received SCS greater than 1 hour prior to initial ED evaluation, those who have received intravenous magnesium sulfate infusion, or subcutaneous terbutaline or epinephrine will be excluded.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center Monroe Carell Jr. Childrens Hospital Pediatric Emergency Department

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Asthma; Lymphoma, Follicular

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Evan H Allie, MD

  Pediatric Emergency Medicine Clinical Fellow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 22, 2015
• First Posted: June 1, 2015
• Study Start: July 1, 2015
• Primary Completion: November 11, 2020
• Study Completion: November 11, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)