Comparison of three methods of oxygen supplementation during flexible bronchoscopy in children: A randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- Incidence of desaturations in children undergoing Flexible bronchoscopy while supplementing oxygen with modified nasopharyngeal insufflation and HFNC compared to nasal cannula in the age group of one month to fifteen years
研究概览
简要总结
There is paucity of data on appropriate method of oxygen supplementation in children undergoing flexible bronchoscopy. HFNC is found to be superior compared to oxygen supplementation by nasal prongs in one pediatric trial, but it requires commercial equipment with ongoing cost. Oxygen supplementation by nasopharyngeal catheter using HFNC device is found to be useful, but its use without standard HFNC device has not been studied. We plan to compare three techniques of oxygen supplementation namely nasal cannula, HFNC, and modified nasopharyngeal catheter without HFNC device during flexible bronchoscopy in children. This study will help in optimizing the management of children undergoing flexible bronchoscopy without significant cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Month(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Children 1 month – 15 years of age.
- •Undergoing elective flexible bronchoscopy examination for any indication.
排除标准
- •The need for preâ€flexible bronchoscopy HFNC, noninvasive ventilation (NIV), or invasive mechanical ventilation (IMV)
- •Flexible bronchoscopy being performed as an emergency procedure.
- •Children on tracheostomy
- •Children with cyanotic heart disease
- •Children undergoing flexible bronchoscopy for endobronchial interventions apart from bronchoscopy and BAL.
结局指标
主要结局
Incidence of desaturations in children undergoing Flexible bronchoscopy while supplementing oxygen with modified nasopharyngeal insufflation and HFNC compared to nasal cannula in the age group of one month to fifteen years
时间窗: Saturation thirty minutes prior to procedure, saturation continuous monitoring during procedure, every 15 minute post procedure for two hours
次要结局
- Proportion of patients with desaturation less than Ninety percent(Saturation thirty minutes prior to procedure, saturation continuous monitoring during procedure, every 15 minute post procedure for two hours)
- Number of patients requiring assisted breathing by bag & mask or Soong’s ventilation(saturation continuous monitoring during procedure, every 15 minute post procedure for two hours . Number of patients requiring assisted breathing, If oxygen saturation less than eighty five percentage, or bradycardia, less than beats per min) for more than five seconds, the bronchoscopy will be interrupted & assisted ventilation will be started)
- Number of procedure interruptions or abandonment(during procedure, every 15 minute post procedure for two hours)
- The lowest oxygen saturation during the procedure.(saturation continuous monitoring during procedure, every 15 minute post procedure for two hours)
- The total duration of desaturations to less than Ninety percent & less than Ninety four percent(Continuous monitoring during procedure, every 15 minute post procedure for two hours)
- Heart rate during the procedure(Saturation thirty minutes continuous monitoring during procedure, every 15 minute post procedure for two hours)
- Adverse events associated with the procedure, Major - post procedure oxygen requirement, intubation & mechanical ventilation, mortality, minor- nasopharyngeal bleeding or fever(continuous monitoring during procedure, every 15 minute post procedure for two hours)
研究者
Maaz Ahmed
AIIMS NEW DELHI