High Flow Nasal Cannula Rates in Pediatric Asthma Exacerbations: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 27
- 试验地点
- 4
- 主要终点
- Percent of participants enrolled
研究概览
简要总结
This is a randomized, open-label, 3-armed feasibility trial will examine conventional oxygen therapy (COT) vs high flow nasal cannula at 4L/min flow vs HFNC at 2L/kg/min flow (max 60L/min) in moderate to severe pediatric asthma exacerbations.
详细描述
The purpose of this feasibility trial is to examine the safety and efficacy of high flow nasal cannula in moderate to severe pediatric asthma exacerbations. Eligible patients will be admitted to the Pediatric Intensive Care Unit (PICU) after initial presentation to the emergency department (ED) or as a transfer from an outside hospital ED. Patients will be admitted to the PICU on standard asthma therapy (continuous albuterol and systemic corticosteroids) based on the discretion of the treating ED physician. Upon PICU admission, eligible patients will be consented, enrolled, and randomized into the study. All patients will be continued on standard asthma therapy of continuous albuterol at 20mg/hr and systemic intravenous corticosteroids. Patient will be randomized into one of three groups: (1) conventional oxygen therapy at 2L/min via standard facemark (control group), (2) high flow nasal cannula at 4L/min, and (3) high flow nasal cannula at 2L/kg/min (max 60L/min). Pediatric Respiratory Assessment Measure (PRAM) scores and vital signs will be taken at baseline and hourly for two hours. After the two-hour long study is completed, patients will be placed on a respiratory support modality as per the treating physician's discretion. Patients will be followed longitudinally after study completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 2-17 years old with prior clinical diagnosis of asthma
- •Admitted to PICU on standard asthma therapy defined as continuous albuterol and systemic corticosteroids
- •Admitted to PICU on either COT or HFNC
- •Admitted to PICU from either Golisano Children's Hospital ED or as a transport from an outside hospital ED within 6 hours of initial presentation
- •PRAM score greater than or equal to 4 after completion of initial ED therapy
排除标准
- •Admitted to the PICU on NIV or invasive mechanical ventilation
- •Admitted to the PICU from general floors or > 6 hours from initial presentation
- •Presence of a tracheostomy or baseline NIV requirement
- •Pregnancy
- •Immunocompromised State
结局指标
主要结局
Percent of participants enrolled
时间窗: 12 months
Percent of participants randomized divided by the percent of participants approached.
次要结局
- Mean Total Duration of Respiratory Support(Until hospital discharge, approximately 5 days)
- Mean Change in Respiratory Rate(Baseline to 2 hours)
- Mean PICU Length of Stay (LOS)(Until hospital discharge, approximately 3 days)
- Percentage of Participants placed on Adjunct Asthma Therapies(Until hospital discharge, approximately 5 days)
- Percentage of Participants who needed Sedation(Until hospital discharge, approximately 5 days)
- Mean Hospital Length of Stay (LOS)(Until hospital discharge, approximately 7 days)
- Mean Change in Pediatric Respiratory Assessment Measure (PRAM) Score(Baseline to 2 hours)
- Mean Total Duration of Continuous Albuterol(Approximately 3 days)
- Percentage of Children with Escalation of Respiratory Support(1 day)
- Percentage of Participants on Antibiotics(Until hospital discharge, approximately 5 days)
研究者
Michele E. Smith
Assistant Professor of Pediatrics
University of Rochester