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

Cincinnati Children's Hospital Medical Center

Status and phase: Terminated; Phase 2

Conditions: Status Asthmaticus

Treatments: Drug: Oxygen; Drug: Helium-oxygen-driven albuterol nebulizer

Study type: Interventional

Funder types: Other

Identifiers

NCT00410150

05-11-34-74-067

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 42 patients

Sex: All

Ages: 24 months to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Group 1 (Heliox-powered albuterol)

Experimental group

Description:

Group 1 (Heliox-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 70:30 Heliox.

Treatment:

Drug: Helium-oxygen-driven albuterol nebulizer

Group 2 (Oxygen-powered albuterol)

Active Comparator group

Description:

Group 2 (Oxygen-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 100% oxygen per usual standard of care.

Treatment:

Drug: Oxygen