Heliox-Powered Albuterol Therapy in the Treatment of Children Admitted With Acute Asthma Exacerbation

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether heliox-powered albuterol nebulizer therapy will result in reduced inpatient length of stay in children hospitalized with acute asthma exacerbations.

Detailed Description
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We hypothesize that heliox-powered albuterol nebulizer therapy will result in reduced inpatient length of stay in children hospitalized with acute asthma exacerbations. Severity of asthma will be characterized using a modified Becker Clinical Asthma Score (CAS) based upon the acuity of physical signs for four clinical characteristics (respiratory rate, wheezing, I/E ratio, and accessory muscle use). Scoring will occur at the time of enrollment and every 4 hours thereafter until the patient meets hospital discharge criteria. All scoring using the CAS will be performed by an independent physician, nurse or respiratory therapist blinded to the subject treatment arm. All children will receive standard cardiopulmonary monitoring and treatment, consisting of supplemental oxygen delivered as needed by either nasal cannula or face mask to maintain oxygen saturation >90%, maintenance intravenous fluids, corticosteroid therapy and nebulized albuterol therapy. After written informed consent, eligible children will be randomized to one of two study groups using a sealed envelope technique: Group 1 (Heliox-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 70:30 Heliox. Group 2 (Oxygen-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 100% oxygen per usual standard of care.

Official Title
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A Prospective, Randomized, Controlled, Single Center Trial of the Use of Heliox in Children Admitted to the Hospital With Status Asthmaticus

Conditions
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Status Asthmaticus

Intervention / Treatment
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* Drug: Helium-oxygen-driven albuterol nebulizer
* Drug: Oxygen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 2 -18 years; Previous history of asthma; Hospital admission for acute asthma exacerbation; Clinical asthma score greater than or equal to 3 Exclusion Criteria: Less than 2 years old or over 18 years old; Known allergy or hypersensitivity to ß-agonists; Require mechanical ventilation (invasive or non-invasive); Require FiO2 >0.4; Failure to obtain informed consent; Enrollment in another investigational drug or asthma protocol; Incipient respiratory failure including but limited to respiratory acidosis(pCO2>60 torr), altered mental status and/or excessive work of breathing.

Ages Eligible for Study
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Minimum Age: 24 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (Heliox-powered albuterol)<br>Group 1 (Heliox-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 70:30 Heliox. | Drug: Helium-oxygen-driven albuterol nebulizer<br>* Subjects will be treated with continuous albuterol nebs with Heliox<br>|
| Active Comparator: Group 2 (Oxygen-powered albuterol)<br>Group 2 (Oxygen-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 100% oxygen per usual standard of care. | Drug: Oxygen<br>* Subjects will be treated with continuous albuterol nebs in oxygen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay | Time to discharge eligibility (hours) | Hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Status asthmaticus, Asthma, Helium, Children