Video Assisted Study of Salbutamol Response in Viral Wheezing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in modified RDAI
研究概览
简要总结
The study is video assisted cross-over study evaluating the effect of inhaled salbutamol in wheeze in children 6-24 months old.
详细描述
The object of the study is to evaluate the effect of inhaled salbutamol in wheeze in children 6-24 months old.
In despite of the lack of evidence of salbutamol, it is considered the gold standard in acute wheezing. Placebo-controlled study would be unethical so all participants are treated with salbutamol based on current guidelines. Instead, participants serve as control subjects of their own which is executed by a type video assisted cross-over study.
Participants are filmed before and after the treatment. Afterwards a panel of pediatricians not participating in the treatment of the participants independently evaluates the difficulty of the wheeze. Videos are randomly arranged and members of the panel are blinded to the time point (before/after) of videos.
In addition, collected videos are analyzed using machine vision. Biosignals are collected from the videos and evaluated using algorithms in order to show that machine vision can be utilized to evaluate the difficulty of wheezing. The machine vision analysis is compared to the evaluation of the panel of pediatricians.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Salbutamol-treatment in emergency department prescribed
排除标准
- •Need for immediate resuscitation
- •Immediate transfer to ICU
- •Suspicion of pneumonia based on the auscultation finding
- •Suspicion of airway foreign body
研究组 & 干预措施
After salbutamol
Participants after the administration of salbutamol
干预措施: Salbutamol (Drug)
结局指标
主要结局
Change in modified RDAI
时间窗: Within 3 hours of study entry
RDAI = Respiratory Distress Assessment Instrument, modified to not include auscultation findings. Range 0-18. Higher score indicates more difficult respiratory distress. Evaluated by the blinded panel afterwards using collected videos. Videos collected immediately before and after the intervention.
次要结局
- Change in saturation of peripheral oxygen(Within 3 hours of study entry)
- Change in auscultation finding(Within 3 hours of study entry)
- Machine-vision assisted analysis of respiratory status(Within 3 hours of study entry)
- Change in the difficulty of the respiratory distress(Within 3 hours of study entry)
研究者
Terhi Tapiainen
Professor of Pediatrics, Head of Pediatric Infectious Diseases and Emergency Department
University of Oulu