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临床试验/NCT00668278
NCT00668278已完成不适用

I-Gel Versus Disposable Laryngeal Mask Airway for General Anesthesia With Controlled Ventilation

Northern Health and Social Care Trust0 个研究点目标入组 200 人开始时间: 2008年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
主要终点
Sealing pressure and peak airway pressure.

研究概览

简要总结

Randomized controlled trial comparing performance of the I-gel and disposable Laryngeal Mask Airways under controlled ventilation. 200 patients, 100 in each arm. Measurement of peak airway and sealing pressures. Postoperative questionnaires at 1 and 24hrs.

Hypothesis

There is no difference between the performance* of the I-gel and disposable laryngeal mask airways for controlled ventilation under general anesthesia.

*as defined by peak airway pressure and sealing pressures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females.
  • Age 18-89 inclusive.
  • ASA grade 1-
  • Elective surgery

排除标准

  • Emergency surgery.
  • Surgery within the peritoneum.
  • Surgery requiring prone or steep head-down positioning.
  • Patients at increased risk of aspiration

结局指标

主要结局

Sealing pressure and peak airway pressure.

时间窗: Under anaesthesia.

次要结局

  • Postoperative patient symptoms(1hr and 24hrs postoperatively)

研究者

申办方类型
Other Gov

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