At a glance
ClinicalIndex Comparison Record- ✓Acute asthma exacerbation presenting to emergency room
- ✓Peak expiratory flow rate <40% of predicted at presentation
- ✓Enrollment within 90 minutes of arrival to ER
- ✓Age 18–55 years
- ✕History of COPD
- ✕Clinical evidence of non-asthmatic cause of bronchospasm
- ✕Clinical evidence of acute coronary syndrome
- ✕Respiratory failure requiring mechanical ventilation (invasive or non-invasive)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effectiveness of the Aeroneb Compared to a Jet Nebulizer Fort the Delivery of Bronchodilator Therapy of Acute Severe Asthma
In Brief
A clinical study evaluating Aeroneb nebulizer and Small volume jet nebulizer for Asthma Exacerbation. Completed, enrolled 31 participants across 1 site.
Detailed Summary
Background: The bronchodilator therapy is an essential component of the management of asthma exacerbation. The delivery of bronchodilators to the lungs in asthma exacerbations is usually achieved through nebulization (creating small particles to be inhaled). The commonly used nebulizer device is a small volume jet nebulizer which has not been consistently reliable in delivering bronchodilator therapy. The Aeroneb nebulizer device is a FDA approved device which produces consistently respirable sized particles which could potentially result in better bronchodilator effect than the standard jet nebulizer. Aim: To study whether the Aeroneb nebulizer is more effective than a small volume jet nebulizer in delivering bronchodilators during a severe asthma exacerbation. Experimental design: Patients will be randomized (like a flip of a coin) to receive bronchodilator therapy as per the emergency room protocol either via small volume jet nebulizer or Aeroneb nebulizer. Subjects: Adult patients between age of 18 and 55 years who present to the emergency room with severe asthma exacerbation with peak expiratory flow rate \<50% of predicted. Study procedure: When enrolled in the study and after randomization, we will then collect data that is standard for the hospital like heart rate, blood pressure and breathing indices and also some non-routine things like some scoring scales for shortness of breath and serial measurements of peak expiratory flow rate. We anticipate that the Aeroneb device will be more effective in delivering bronchodilator medication and thus more effective in managing asthma exacerbations.
Study Details
Timeline
Interventions
The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation. The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).
The bronchodilators will be administered via small volume jet nebulizer