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临床试验/NCT04722276
NCT04722276已完成不适用

The Effect of Positive End-expiratory Pressure During Induction of General Anesthesia and Non-hypoxic Apnea Time in Infants: a Randomized Controlled Trials

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2021年2月1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
84
试验地点
2
主要终点
apnea time

研究概览

简要总结

Invesetigators evaluated the effect of positive end-expiratory pressure during anaesthesia induction on nonhypoxic apnoea time in infants. Invesetigators assigned infants to a 7 cmH2O positive end expiratory pressure (PEEP) with fraction of inspired oxygen 80% or 0 cmH2O PEEP with fraction of oxygen 80% group. Anaesthesia was induced with 0.02 mg kg atropine, 5 mg kg thiopental sodium and 3 to 5% sevoflurane, and neuromuscular blockade with 0.6 mg kg rocuronium. Thereafter, 80% oxygen was provided via face mask with volume-controlled ventilation of 6 ml kg tidal volume, and either 7 cmH2O or no positive end-expiratory pressure. After 3 min of ventilation, the infants' trachea was intubated but disconnected from the breathing circuit, and ventilation resumed when pulse oximetry reached 95%.

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

入选标准

  • We included paediatric patients aged 12 months or less about to receive general anaesthesia with endotracheal intubation.

排除标准

  • Neonates, former preterm infants with gestational age less than 60 weeks at the day of surgery, with previous history of respiratory disease, those with anticipated difficult mask ventilation or intubation and those with upper respiratory infection within 3 weeks were excluded.

结局指标

主要结局

apnea time

时间窗: during face mask ventilation, maximum 3 minutes.

The primary outcome was nonhypoxic apnoea time defined as the time from cessation of ventilation to a pulse oximeter reading of 95%

次要结局

  • atelectasis score (0~72)(during anesthesia induction, maximum 5 minutes.)
  • Number of participants with gastric air insufflation(during anesthesia induction, maximum 5 minutes.)

研究者

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

Hee-Soo Kim

professor

Seoul National University Hospital

研究点 (2)

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