跳至主要内容
临床试验/NCT01385969
NCT01385969已完成不适用

Using the Natural Recoil of the Inflating Syringe as a Safety Valve to Limit LMA Cuff Pressure and Decrease LMA-Induced Complications

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
360
试验地点
2
主要终点
Pressure of the syringe after inflation of the LMA cuff

研究概览

简要总结

The purpose of this study is to determine if using 20 mL B.Braun syringes to inflate LMAs and allowing them to recoil will put the pressure of the LMA cuff within the safety range. It will also determine if remaining within this safety range has an effect on complications after surgery..

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Registered Mayo Clinic in Florida patients scheduled to undergo a surgery
  • Planned use of LMA during surgery
  • between the ages of 18-99
  • short duration (<2 hours elective surgery)

排除标准

  • recent history of upper respiratory tract infection
  • intra-cavitary or laparoscopic procedure
  • risk of pulmonary aspiration
  • known difficult airway
  • history of gastric reflux
  • BMI > 40
  • lateral or prone positions
  • oral or nasal surgery

结局指标

主要结局

Pressure of the syringe after inflation of the LMA cuff

时间窗: after inflation, 1 hour into surgery

次要结局

  • Number of patients with dysphagia and/or dysphonia(1, 2, and 24 hours after surgery)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher B. Robards

MD

Mayo Clinic

研究点 (2)

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