A Prospective, Randomized Trial of Early Versus Delayed BiPAP Administration or Non-positive Pressure Therapy in the Management of Pediatric Status Asthmaticus
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Clinical Asthma Scores
研究概览
简要总结
Though BiPAP is an increasingly common tool used by pediatric critical care physicians and there is promising data suggesting a role for BiPAP in the management of status asthmaticus, more information is needed to more definitively clarify the extent of its benefit, as well as when during an asthma exacerbation and in whom it is the most beneficial. In this study, which is among the first randomized studies of BiPAP use for status asthmaticus in the pediatric population, the investigators hope to better elucidate these issues to help guide clinicians' future management decisions.
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
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary diagnosis of asthma exacerbation
- •Admitted to Cohen Children's Medical Center (CCMC) PICU
- •CCMC respiratory severity score of 6 or higher at the time of enrollment
- •Prior history of asthma or reactive airway disease
排除标准
- •No prior history of asthma or reactive airway disease
- •Facial or airway anomalies precluding BiPAP mask use
- •Tracheostomy
- •Lack of airway protective reflexes
- •Neurologic or musculoskeletal abnormalities affecting respiration
- •Underlying cardiovascular problems that may be negatively affected by positive pressure ventilation
- •Intracranial problems (such as in the setting of head injury) that may be negatively affected by positive pressure ventilation
- •Respiratory compromise for which emergent endotracheal intubation or non-invasive positive pressure ventilation is warranted as determined by the on-service attending physician
研究组 & 干预措施
Control
Patients assigned to the "control" group will receive any treatment for status asthmaticus that does not entail use of positive pressure ventilation.
Late BiPAP treatment
Patients assigned to the "late treatment" group will be started on BiPAP greater than 6 hours after randomization.
干预措施: BiPAP treatment (Device)
Early BiPAP treatment
Patients assigned to the "early treatment" group will be started on BiPAP as soon as possible after randomization.
干预措施: BiPAP treatment (Device)
结局指标
主要结局
Clinical Asthma Scores
时间窗: 3 hours after enrollment
Both PRAM and CCMC clinical asthma scores
次要结局
- Length of stay in intensive care unit (ICU)(ICU stay -- Expected to be approximately 3 days on average)
- Dyspnea Scores(0 hours, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, and 36 hours after enrollment)
- BiPAP Tolerance(Hospitalization)
- Length of stay in hospital(Hospital length of stay -- Expected to be approximately 5 days on average)
- Side effects or adverse events(Hospitalization)
- Clinical Asthma Scores(0 hours, 6 hours, 9 hours, 12 hours, 24 hours, and 36 hours after enrollment)
研究者
Sandeep Gangadharan
Attending physician
Northwell Health