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临床试验/NCT05578131
NCT05578131已完成不适用

The Effectiveness of Preoxygenation and Apneic Oxygenation Using High-flow Nasal Cannula for Pediatric Anesthetic Induction: a Prospective Randomized Open-label Clinical Trial

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2022年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
132
试验地点
1
主要终点
Occurrence of oxygen desaturation <95%

研究概览

简要总结

Endotracheal intubation in infants often involves more than one attempt, and oxygen desaturation is common. It is unclear whether nasal high-flow therapy, which extends the time to desaturation during elective intubation in infants receiving general anesthesia, can decrease the occurence of desaturation during intubation.

The investigators tested the hypothesis that high-flow nasal oxygen cannulae would be effective in maintaining oxygen saturation during intubation than facemasks for pre-oxygenation. The investigators randomly allocated 132 patients undergoing elective surgery aged <=12 months to pre-oxygenation using either high-flow nasal oxygen or facemask.

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
None

入排标准

年龄范围
1 Month 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants undergoing general anesthesia with endotracheal intubation.

排除标准

  • infants who diagnosed as cardiorespiratory problem preoperatively.

结局指标

主要结局

Occurrence of oxygen desaturation <95%

时间窗: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.

次要结局

  • Occurrence of rescue bag mask ventilation(from induction of anesthesia to 1 minutes after intubation, about 10 minutes.)
  • the changes in oxygen reserve index(from induction of anesthesia to 1 minutes after intubation, about 10 minutes.)
  • Number of intubation attempts(from induction of anesthesia to 1 minutes after intubation, about 10 minutes.)
  • Occurrence of oxygen desaturation <90%(from induction of anesthesia to 1 minutes after intubation, about 10 minutes.)
  • the lowest oxygen saturation(from induction of anesthesia to 1 minutes after intubation, about 10 minutes.)
  • ETCO2 in first breath after intubation(from induction of anesthesia to 1 minutes after intubation, about 10 minutes.)
  • ETO2 in first breath after intubation(from induction of anesthesia to 1 minutes after intubation, about 10 minutes.)
  • Intubation times(from induction of anesthesia to 1 minutes after intubation, about 10 minutes.)
  • Occurrence of gastric insufflation(from induction of anesthesia to 1 minutes after intubation, about 10 minutes.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eun-hee Kim

Clinical associate professor

Seoul National University Hospital

研究点 (1)

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