Asthma in Children, Status Asthmaticus
Conditions
Keywords
non-invasive ventilation, BPAP, continous albuterol, pediatrics
Brief summary
The investigators aim to study the effect and safety of bilevel positive airway pressure (BPAP) in children with moderate to severe asthma exacerbations - by examining the effects of early initiation of BPAP in pediatric patients who present to the emergency room with a moderate to severe asthma exacerbation. The study is interested in how early initiation of BPAP affects PRAM scores, vital signs, as well as the total duration of continuous albuterol in the patient population.
Detailed description
Asthma is the most common chronic illness of childhood. Bilevel positive airway pressure (BPAP) has been suggested as an adjunct therapy in the setting of moderate to severe asthma exacerbations. It is a form of noninvasive positive pressure ventilation that provides both an inspiratory positive airway pressure (IPAP) as well as an expiratory positive airway pressure (EPAP). The goal of this study is to determine the feasibility of enrolling, randomizing, and completing data collection in at least 30 participants over a one-year period. The investigators will enroll children 5 to 17 years of age presenting to the emergency department with a moderate to severe asthma exacerbation. Eligible participants will be randomized into two groups: standard therapy (continuous albuterol) or standard therapy plus BPAP. The following data will be collected: Pediatric Respiratory Assessment Measure (PRAM) score at 0, 2 and 4 hours, vital signs at 0, 2 and 4 hours, rate of adverse events and Pediatric Intensive Care Unit (PICU) admissions, duration continuous albuterol, length of hospital stay, and rates of intubations or deaths.
Interventions
DEVICEPhilips Respironics V60 Non-invasive ventilator, BPAP
Continuous albuterol will be administered through the BPAP circuit.
OTHERStandard Therapy
Standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 5 to 17 years of age (inclusive) presenting to the Emergency Department (ED) with an asthma exacerbation * Prior clinician diagnosis of asthma * PRAM score of 4 or greater after initial albuterol/atrovent back to backs, steroids, +/- oxygen * Need for continuous nebulized albuterol therapy
Exclusion criteria
* Hypercapneic respiratory failure (partial pressure of carbon dioxide \> 60 mmHg) * Hypoxemic respiratory failure (SaO2 \< 90% with fraction of inspired oxygen \> 0.35) * Presence of a tracheostomy or baseline noninvasive ventilation requirement * Non-asthma causes of wheezing (foreign body, tracheomalacia, vocal cord dysfunction, pulmonary edema, uncorrected congenital heart disease, cystic fibrosis) * Contra-indication to BPAP (facial trauma, uncontrollable vomiting, hypotension for age, Glasgow Coma Scale (GCS) 8 or less, drowsiness or confusion, known or clinical suspicion for pneumothorax, pneumomediastinum, or subcutaneous emphysema, pregnancy, current weight \< 20kg)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of successfully enrolling, randomizing, and completing data collection in 30 participants within one year. | One year | Feasibility defined as successfully enrolling, randomizing, and completing data collection in 30 participants within one year in the pediatric emergency department. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Systolic and Diastolic Blood Pressure | At 2 and 4 hour time points | Difference in systolic and diastolic blood pressure measured in millimeters of mercury (mmHg). |
| Difference in PRAM Score | At 2 and 4 hour time points | Difference in PRAM scores at 2 and 4 hours. PRAM scores range from 0 to 12 with a score of 4 or greater indicating moderate to severe disease. Decreasing scores reflect clinical improvement in response to therapy. |
| Difference in Respiratory Rate | At 2 and 4 hour time points | Difference in respiratory rate measured in breaths per minute (bpm). |
| Difference in Oxygen Saturation | At 2 and 4 hour time points | Difference in percent oxygen saturation. |
| Difference in Duration of continuous beta-agonist therapy | Until therapy is completed, approximately 24 hours | Difference in duration of continuous beta-agonist therapy measured in hours. |
| Rate of PICU Admission | Until hospital discharge, approximately 2 days | Rate of admissions from the Emergency Department (ED) to PICU versus home or to the pediatric floor |
| Length of Stay | Until hospital discharge, approximately 2 days | Length of stay, measured in days, in the ED, PICU, or hospital |
| Difference in Heart Rate | At 2 and 4 hour time points | Difference in heart rate measured in beats per minute (bpm). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Number of Adverse Events | Until hospital discharge, approximately 2 days | The total number of adverse events per arm will be reported. Adverse events include air leak syndrome, aspiration pneumonia, skin break down, hypotension, intubation, death or other adverse events. |
Outcome results
None listed