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临床试验/NCT03127683
NCT03127683已完成不适用

The Influence of Head and Neck Position on Performance of Ambu AuraGainTM in Children

Seoul National University Hospital2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2017年5月15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
40
试验地点
2
主要终点
Oropharyngeal leak pressure

研究概览

简要总结

The influence of different head and neck positions on the effectiveness of ventilation with the Ambu AuraGain airway remains unevaluated.

This study aimed to evaluate the influence of different head and neck positions on ventilation with the AuraGain airway.

An AuraGain will be placed in all patients, and mechanical ventilation will be performed using a volume-controlled mode with a tidal volume of 10 ml/kg.

The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed first for the neutral head position and then for the extended, flexed, and rotated head positions in a random order.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
— 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children < 7 years old who scheduled for general anesthesia using supraglottic airway

排除标准

  • Children who require tracheal intubation
  • Emergency operation without NPO
  • History of C-spine surgery or disease
  • History of Esophageal disease or surgery

结局指标

主要结局

Oropharyngeal leak pressure

时间窗: 30 seconds after positioning of head and neck

The airway pressure at which a leak sound is detected around the patient's mouth and at which the airway pressure has reached equilibrium, when the pressure-limiting valve of the anesthesia breathing system is closed and the fresh gas flow rate was fixed at 3 L/min

次要结局

  • Tidal volume(30 seconds after positioning of head and neck)
  • Peak inspiratory pressure(30 seconds after positioning of head and neck)
  • Fiberopic bronchoscopic view(30 seconds after positioning of head and neck)

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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