Effect of High-flow Nasal Oxygenation on Safe Apnea Time in Children With Open Mouth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Apnea success rate
研究概览
简要总结
This is a prospective randomized controlled trial comparing high flow nasal cannula and buccal oxygenation as method of oxygenation during apnea in children.
详细描述
This is a prospective randomized controlled trial comparing two oxygenation methods for prolongation of apnea time in children aged 0 to 10 years old.
This study measures time for the pulse oximetry drop from 100% to 92% after oxygenation with 100% oxygen, applying high flow nasal cannula or buccal oxygen insufflation via an oral Ring-Adair-Elwyn endotracheal tube connected to oxygen.
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
- Single (Participant)
入排标准
- 年龄范围
- — 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children under 11 years old undergoing general anesthesia with American Society of Anesthesiologists Physical Status 1 or 2.
排除标准
- •Refusal of enrollment from one or more legal guardians of the patient
- •Plan of usage of supraglottic airway device as airway maintenance device
- •Presence of upper respiratory tract infection of lung disease
- •Premature infants younger than postconceptual age of 40 weeks
- •Anticipation of difficult bag-mask ventilation due to facial anomaly or micrognathia
- •Other conditions that are considered inappropriate for the study
结局指标
主要结局
Apnea success rate
时间窗: From start of apnea to drop of pulse oximetry to 92%, up to 520 seconds
Proportion of patients that succeed in prolongation of apnea time while maintaining pulse oximetry \> 92%
次要结局
- End-tidal carbon dioxide(After resuming of bag-mask ventilation, up to 30 seconds)
- Pulse oximetry(From start of study to end of study, up to 20 min)
- Apnea time(From start of apnea to drop of pulse oximetry to 92%, up to 520 seconds)
- Time to pulse oximetry of 100 percent(After resuming of bag-mask ventilation, up to 300 seconds)
- Minimal pulse oximetry(After resuming of bag-mask ventilation, up to 60 seconds)
- Electrocardiogram(From start of study to end of study, up to 20 min)
- Mean blood pressure(From start of study to end of study, up to 20 min)
- Oxygen reserve index(From start of study to end of study, up to 20 min)
- Transcutaneous carbon dioxide(From start of study to end of study, up to 20 min)
- Heart rate(From start of study to end of study, up to 20 min)
研究者
Jin-Tae Kim
MD, PhD, Professor
Seoul National University Hospital