A Randomized Trial Comparing Metered Dose Inhalers and Breath Actuated Nebulizers
NCT ID: NCT02777125
Last Updated: 2017-08-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
980 participants
INTERVENTIONAL
2014-10-31
2015-04-30
Brief Summary
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Detailed Description
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Metered dose inhalers with spacers are more readily available to the general population, are easily transportable and do not require a power source. Demonstrating equal effectiveness of albuterol delivery systems for treatment of acute pediatric asthma exacerbations would enable physicians to confidently utilize clinical encounters as opportunities to educate families on management of asthma exacerbations using their home appliance.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Albuterol by Metered Dose Inhaler
Albuterol administered via MDI and spacer device with weight and severity based dosing. For weight less than 20 kg: mild and moderate disease 540mcg of albuterol per dose. For weight greater than or equal to 20 kg: mild disease 540 mcg of albuterol per dose and moderate disease 1080 mcg of albuterol per dose.
Metered Dose Inhaler
A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths.
Albuterol Breath Actuated Nebulizer
Subjects randomized to BAN were evaluated for proper breath actuation technique. For subjects unable to coordinate breath actuation, the RT attached an appropriately sized mask to the device, changed the setting to continuous nebulization and returned upon completion of the treatment. Albuterol dosing was based upon the subject's weight and presenting symptom severity. Children presenting in the mild and moderate severity category weighing less than 20kg, received 2500mcg of albuterol. Children weighing more than 20kg, received 2500mcg of albuterol if their presentation met mild severity criteria, or 5000mcg if they met moderate criteria.
Breath Actuated Nebulizer
The breath actuated nebulizer (BAN) device is a device that converts liquid medication, in this case albuterol, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be attached to a mask and set to continuous nebulization for patients that are not able to coordinate their breaths.
Interventions
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Metered Dose Inhaler
A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths.
Breath Actuated Nebulizer
The breath actuated nebulizer (BAN) device is a device that converts liquid medication, in this case albuterol, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be attached to a mask and set to continuous nebulization for patients that are not able to coordinate their breaths.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Congenital heart disease, tracheostomy, or were receiving diuretic therapy.
* Patients diagnosed by the treating physician with bronchiolitis or pneumonia were excluded along with children who were wards of the state or whose parents did not speak English.
2 Years
17 Years
ALL
No
Sponsors
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University of Tennessee
OTHER
Le Bonheur Children's Hospital
OTHER
Responsible Party
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Mark Snider
Pediatric Emergency Medicine Fellow
Principal Investigators
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Mark A Snider, DO
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee
References
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Other Identifiers
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LeBonheurCH
Identifier Type: -
Identifier Source: org_study_id
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