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临床试验/NCT04290728
NCT04290728终止不适用

Effect of High-flow Nasal Oxygenation on Safe Apnea Time in Children With Open Mouth

Seoul National University Hospital2 个研究点 分布在 2 个国家目标入组 15 人开始时间: 2020年4月16日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
15
试验地点
2
主要终点
Apnea time

研究概览

简要总结

This study aims to evaluate the effect of high-flow nasal oxygenation on safe apnea time for children undergoing general anesthesia, with their mouth open.

详细描述

Oxygenation via high-flow nasal cannula is gaining popularity in various clinical settings. It is known to increase apnea time for apneic patients including children. However, high-flow nasal cannula is known to be ineffective when the patient's mouth is kept open.

When trying to intubate the patient during induction of anesthesia, the patient should be apneic with administration of neuromuscular blocking agent, and the mouth should be open for introduction of laryngoscope.

We designed a prospective randomized controlled study to evaluate the effect of high-flow nasal oxygenation in the aforementioned setting for trying to intubate the patient.

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
— 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children younger than 11 years old scheduled to undergo surgery under general anesthesia, with American Society of Anesthesiologists Physical Status 1 or 2.

排除标准

  • Refusal to enrollment from one or more of legal guardians of the patient
  • Children who are planned to use supraglottic airway device
  • Children with upper respiratory tract infection or pulmonary interstitial disease
  • Preterm babies under 40 weeks of postconceptual age
  • Children who are expected to have difficult airway for bag-mask ventilation

结局指标

主要结局

Apnea time

时间窗: Elapsed time starting from discontinuation of oxygen to the time point that pulse oximetry first reaches 92% (not to exceed 520 seconds)

Time required for pulse oximetry to drop to 92% after start of apnea

次要结局

  • Pulse oximetry(Procedure (From induction of anesthesia to end of anesthesia))
  • Time to 100%(Elapsed time starting from re-start of bag-mask ventilation at the end of apnea period to the time point that pulse oximetry first reaches 100% (estimated less than 2 minutes))
  • End-tidal carbon dioxide(Procedure (From induction of anesthesia to end of anesthesia))
  • Non-invasive blood pressure(Procedure (From induction of anesthesia to end of anesthesia))
  • Oxygen reserve index(Procedure (From induction of anesthesia to end of anesthesia))
  • Minimum value of pulse oximetry(Procedure (From induction of anesthesia to end of anesthesia))
  • 1st value of end-tidal carbon dioxide(At expiration of the first manual ventilation after the end of the apnea period (less than 520 seconds after start of apnea period))

研究者

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

Jin-Tae Kim

Professor

Seoul National University Hospital

研究点 (2)

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