Early Noninvasive Positive Pressure Ventilation in Children With Status Asthmaticus
- Conditions
- Status Asthmaticus
- Interventions
- Other: NPPV plus standard of care
- Registration Number
- NCT01188473
- Lead Sponsor
- Southern Illinois University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- children, 1- 18 years of age, with a known history of asthma admitted to the PICU at St John's Children's Hospital with status asthmaticus
- clinical asthma score (CAS) between 3 - 8 after receiving one dose of systemic steroid, 1 hour of continuous albuterol (SABA), and 3 doses of ipratropium bromide
- written informed consent from the patient's parent or legal guardian
- no previous history of asthma,
- absence of airway protective reflexes,
- absence of respiratory drive,
- excessive oral secretions,
- need for emergent intubation as determined by the attending physician,
- facial or airway anomaly or injury precluding the use of tight fitting mask
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NPPV plus standard of care NPPV plus standard of care NPPV initiated early and for a prolonged period of time in addition to standard of care in the management of children admitted to the hospital with status asthmaticus
- Primary Outcome Measures
Name Time Method clinical asthma score (CAS) initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation clinical evaluations such as wheezing, degree of air exchange, respiratory rate, I\&E ratio, retractions
- Secondary Outcome Measures
Name Time Method transcutaneous oxygen saturation initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation mental status initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation observation of activity level, agitation, etc.
supplemental oxygen initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation NPPV related side effects initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation NPPV related side effects could be minor including nasal bridge pain and skin irritation, gastric insufflations, sinus and ear pain, and dry eyes
heart rate initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation determined by heart monitor
being able to wear the mask initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation Patient is able to keep the mask on for 24 hours.
Trial Locations
- Locations (1)
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States