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临床试验/NCT02751047
NCT02751047已完成不适用

Comparison Between Pressure Controlled Mechanical Ventilation and Manual Ventilation During Mask Ventilation for Induction of Anesthesia in Children

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2016年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
154
试验地点
2
主要终点
Incidence of gastric insufflation

研究概览

简要总结

The investigator will compare the feasibility of manual ventilation and pressure-controlled mechanical ventilation during facemask ventilation in children. The hypothesis is that the incidence of gastric insufflation would be lower during pressure-controlled mechanical ventilation when compared to manual ventilation.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
1 Month 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with American Society of Anesthesiologist (ASA) physical status 1, 2
  • Children with normal body mass index

排除标准

  • Difficult airway management
  • pulmonary disease
  • upper respiratory infection
  • risk of pulmonary aspiration
  • intestinal obstruction or abdominal distension
  • stroke history or moyamoya disease

研究组 & 干预措施

Manual ventilation

Placebo Comparator

During anesthetic induction, facemask ventilation is performed by manual bagging, after setting adjustable pressure limiting (APL) valve at 13 cmH2O. During mask ventilation, gastric ultrasonography is continuously performed to detect gastric insufflation.

干预措施: manual ventilation (Other)

Pressure controlled mechanical ventilation

Active Comparator

During anesthetic induction, facemask ventilation is performed with mechanical ventilator by pressure controlled mode, with inspiratory pressure of 13 cmH2O. During mask ventilation, gastric ultrasonography is continuously performed to detect gastric insufflation.

干预措施: Pressure controlled mechanical ventilation (Other)

结局指标

主要结局

Incidence of gastric insufflation

时间窗: During facemask ventilation (90 seconds)

次要结局

  • The number of patients with adequate tidal volume(During facemask ventilation (90 seconds))

研究者

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

Jin-Tae Kim

Associated professor

Seoul National University Hospital

研究点 (2)

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