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

NCT02458482 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-11-13

No results posted yet for this study

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

Interventions

DEVICE

AccuPAP

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.

DRUG

Albuterol and Ipratropium Continuous Nebulizer

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

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Evan H Allie, MD · Pediatric Emergency Medicine Clinical Fellow

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2020-11-11
Completion
2020-11-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02458482 on ClinicalTrials.gov