Safety and Efficacy of Early Initiation of Noninvasive Positive Pressure Ventilation in Pediatric Patients Admitted With Status Asthmaticus
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- clinical asthma score (CAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
clinical asthma score (CAS)
时间窗: 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
次要结局
- 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)
- 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)
- heart rate(initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation)
- being able to wear the mask(initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation)