跳至主要内容
临床试验/NCT02441257
NCT02441257Unknown不适用

Incidence of Gastroesophageal Reflux During LMA Application in Control and Spontaneous Ventilation

Zhenmeng Wang0 个研究点目标入组 200 人开始时间: 2015年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
200
主要终点
incidence of gastroesophageal reflux of participants

研究概览

简要总结

Laryngeal mask airway is seldom used for control ventilation in America, while it is popular in China. The question is whether the incidence of gastroesophageal reflux in control ventilation is really higher than in spontaneous ventilation. So the investigators combine the third generation laryngeal mask and catheter-based Digitrapper ph-Z monitor system to evaluate the exact incidence of gastroesophageal reflux in these two groups.

详细描述

Patients scheduled for LMA ventilation are divided into two groups randomly, control ventilation group and spontaneous ventilation group. After the third generation laryngeal mask is inserted, catheter-based Digitrapper ph-Z monitor system is applied to measure the exact incidence of gastroesophageal reflux in these two groups.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients for lower extremity operations;
  • •patients for urological operations;
  • •patients for gynecological operations.

排除标准

  • •gastroesophageal reflux disease;
  • •body mass index more than 30.

研究组 & 干预措施

control ventilation

Experimental

patients are scheduled to receive control or spontaneous ventilation

干预措施: control ventilation (Procedure)

control ventilation

Experimental

patients are scheduled to receive control or spontaneous ventilation

干预措施: spontaneous ventilation (Procedure)

结局指标

主要结局

incidence of gastroesophageal reflux of participants

时间窗: participants will be monitored for the duration of laryngeal mask application, an expected average of 1.5 hours

evaluate the exact incidence of reflux in LMA patients with catheter-based Digitrapper ph-Z monitor system

次要结局

未报告次要终点

研究者

发起方
Zhenmeng Wang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zhenmeng Wang

Doctor

Eastern Hepatobiliary Surgery Hospital

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