2005 OPEN FORUM Abstracts
A RANDOMIZED CONTROLLED TRIAL COMPARING A BREATH ACTIVATED NEBULIZER TO STANDARD INTERMITTENT AND ONE-HOUR CONTINUOUS ALBUTEROL IN THE TREATMENT OF EMERGENCY ROOM PEDIATRIC ASTHMA.
Katie Sabato MS RRT, Priscilla Ward RRT, Will Hawk MD. Children's Hospital and Research Center at Oakland.
BACKGROUND: Bronchodilator treatments for asthma can be provided by a various number of aerosol generating devices and methods. To date, there are few large randomized, controlled trials comparing the efficacy, effectiveness and safety of undiluted and continuous diluted administration of albuterol in the treatment of pediatric asthma. Data are also limited on whether certain nebulizers and their masks are more effective than others and whether blow-by treatments area at all effective. Children's Hospital and Research Center at Oakland (CHRCO) Respiratory Care Department is currently conducting a large randomized controlled study comparing the efficacy of a one-time treatment with the AeroEclipse breath actuated small volume nebulizer (BA SVN) used with mask or mouthpiece, to a one-time treatment with a standard small volume nebulizer (SSVN) or a one-hour continuous treatment (CONT) for asthmatics presenting to the emergency room (ER).
METHODS: Patients are eligible for inclusion if they are admitted to the ER for respiratory distress, are 0 months to 18 years of age, and have wheezing or are in status asthmaticus. Patients are objectively assessed utilizing a CHRCO designed clinical asthma score (CAS) and peak flows when possible. The CAS scores clinical wheezing on a scale from 0 to 11, with 11 representing the most severe distress. Patients are stratified by CAS score (CAS < 4 and > 4) and weight (< 20 kg and > 20kg). Patients are randomized to receive their first bronchodilator treatment in the ER via the BA SVN, SSVN, or CONT. Bronchodilator doses for the BA SVN and SSVN are: 0.5cc (2.5 mg) Albuterol in 0.5cc normal saline for patients < 20 kg, and 1cc (5.0 mg) undiluted Albuterol for patients > 20 kg. Bronchodilators given via the CONT method use 2.0cc (10 mg) Albuterol in 18cc normal saline. Patients are evaluated at baseline and again 10 minutes after completion of the assigned treatment. Primary endpoints include change in CAS pre/post treatment, need for additional bronchodilator treatments, and time spent in the emergency room. Secondarily, we will be reporting on the ability of infants to breath activate the BA SVN, the effectiveness of different aerosol interface adapters (patients utilizing the mouthpiece, vented and non-vented aerosolized masks versus blow-by administration), and incidence of side effects documented with each of the approaches.
RESULTS: As of 6/16/05, we have enrolled 87 of the ultimate 150 patients into the study. The patients enrolled thus far reflect a wide range of ages and disease severity as indicated by the CAS prior to treatment. We have enrolled 54 male and 33 female patients. They represent the following ages: 29 patients < 2 years, 20 patients between 3-5 years and 38 patients > 5 years. CAS scores of those enrolled are: 17 with CAS < 4, 29 with CAS between 4-5, and 41 with CAS > 6. Our Interim safety analysis indicates that no patient has sustained any unexpected adverse side effects associated with any of the three methods of treatment.
DISCUSSION: We anticipate enrollment to be completed by November 2005, at which time, data will be analyzed and outcomes evaluated. Interim analysis has not been done to save significance for the final analysis. Final data analysis and summary will be available for the AARC Congress in December 2005.