Status Asthmaticus Clinical Trial
Official title:
Safety and Efficacy of Early Initiation of Noninvasive Positive Pressure Ventilation in Pediatric Patients Admitted With Status Asthmaticus
Status asthmaticus is recognized as a common cause of morbidity in children in the United States. In recent years, hospitalization rates have reached an all time high. This study will evaluate the safety, tolerability and clinical benefit of adding Noninvasive Positive Pressure Ventilation (NPPV)to regular care in children with moderate to moderately severe status asthmaticus.
Status asthmaticus is defined as severe asthma that fails to respond to inhaled short acting
β agonists (SABA), oral or intravenous steroids, and oxygen, leading to hospital admission
for further management (1). In 2004, asthma exacerbations led to 3% (198,000) of all
hospitalizations and 2.5 deaths per 1 million populations in the 0-17 year age group (2).
This prospective, unblinded, randomized controlled, pilot clinical trial will compare NPPV
plus standard of care versus standard of care alone in children admitted for status
asthmaticus. NPPV refers to the delivery of pressurized gas through an external interface
such as a nasal or oronasal mask, connected to a pressure targeted ventilator. In other
words, it provides ventilator support without the use of an endotracheal tube.
This study will investigate the safety, tolerability and efficacy of early initiation of
non-invasive NPPV in pediatric patients admitted with status asthmaticus.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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