Nebulized Corticosteroid for Post Extubation Stridor in Children: A Randomized Double Blind Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- post-extubation stridor
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and adverse effect of nebulized corticosteroid to prevent post-extubation stridor in children.
详细描述
The guideline for prevention and treatment of post-extubation stridor in children is inconclusive include Nebulized epinephrine and intravenous corticosteroid. Nebulized corticosteroid is alternative treatment for viral croup. the rationale of this study to evaluate the efficacy of nebulized fluticasone propionate to prevent pediatric post-extubation stridor
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children age between 1 month old - 18 year old who was intubated
排除标准
- •Palliative care
- •Anatomical abnormalities of airway; subglottic stenosis
- •Neuromuscular disease with negative inspiratory force < - 30 mmHg
- •Need positive pressure after extubation
研究组 & 干预措施
fluticasone propionate
Fluticasone 1 mg + Normal saline (NSS) upto 4 ml nebulized after extubation
干预措施: fluticasone propionate (Drug)
placebo
Normal saline (NSS) 4 ml nebulized after extubation
干预措施: Placebo (Drug)
结局指标
主要结局
post-extubation stridor
时间窗: 6 hours
patient who developed stridor after extubation within 6 hours
次要结局
- treatment failure(24 hour)
- adverse events(24 hour)
研究者
Nattachai Anantasit
Assistant Professor
Ramathibodi Hospital