跳至主要内容
临床试验/NCT02259569
NCT02259569已完成不适用

Comparison of Peak Airway Pressure and Gastric Insufflation in Pressure-Controlled Ventilation or Volume-Controlled Ventilation With I-Gel in Pediatric Patient

Yonsei University0 个研究点目标入组 34 人开始时间: 2014年10月1日最近更新:
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
34
主要终点
Gastric insufflation determined by increase of cross sectional area of gastric antrum, measured by ultrasonography.

研究概览

简要总结

The purpose of this study is to compare peak airway pressure and gastric insufflation in Pressure-Controlled Ventilation or Volume-Controlled Ventilation with I-Gel in pediatric 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
Double (Participant, Care Provider)

入排标准

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

入选标准

  • •① ASA I-II patients aged between 1 and 7 year undergoing elective urologic surgery.

排除标准

  • •parent refusal
  • •clinically significant respiratory disease ③ congenital airway abnormalities, oropharyngeal or facial pathology ④ risk of aspiration

研究组 & 干预措施

PCV group

Experimental

After insertion of I-gel, mechanical ventilation of the lungs was commenced. Mechanical ventilator was set to obtain a tidal volume of 8ml/kg in pressure-controlled mode.

干预措施: Pressure-controlled ventilation (Other)

VCV group

Active Comparator

After insertion of I-gel, mechanical ventilation of the lungs was commenced. Mechanical ventilator was set to obtain a tidal volume of 8ml/kg in volume-controlled mode.

干预措施: Volume-controlled ventilation (Other)

结局指标

主要结局

Gastric insufflation determined by increase of cross sectional area of gastric antrum, measured by ultrasonography.

时间窗: 1 min after I-gel insertion

次要结局

  • oropharyngeal leak pressure(1 min after caudal block)
  • FOB grade(1 min after I-gel insertion)
  • peak airway pressure(1 min after I-gel insertion)

研究者

申办方类型
Other
责任方
Sponsor

相似试验