NCT00410150

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 24 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Status Asthmaticus

Interventions

Type	Name	Description
DRUG	Helium-oxygen-driven albuterol nebulizer	Subjects will be treated with continuous albuterol nebs with Heliox
DRUG	Oxygen	Subjects will be treated with continuous albuterol nebs in oxygen

Timeline

• Start date: 2006-04-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2006-12-12
• Last updated: 2010-11-08
• Results posted: 2010-10-13

Locations

1 site across 1 country: United States