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临床试验/NCT01340638
NCT01340638Unknown3 期

EFFECTIVENESS OF SEAL PRESSURE IN AIRWAY OF THE CLASSIC LARYNGEAL MASK AND THE COOKGAS LARYNGEAL MASK IN ADULT PATIENTS UNDERGOING SURGERY IN AMBULATORY SETTINGS

Universidad de Antioquia1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
3 期
入组人数
106
试验地点
1
主要终点
Seal pressures

研究概览

简要总结

The working hypothesis in this study is that the supraglottic device COOKGAS provides seal pressure as well or better than LMAc ™ when adult patients undergoing outpatient surgery, are sommeted to both interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, 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

入选标准

  • Over 18 years
  • Patient ASA I, II and III
  • Complete fast
  • Ambulatory Surgery
  • Time less than two hours surgically
  • Supine Surgery
  • Acceptance of informed consent

排除标准

  • No acceptance of informed consent
  • Pregnancy or breastfeeding
  • Hemostatic alterations
  • Abdominal surgery
  • History of gastrointestinal reflux
  • BMI over 35
  • Mouth opening less than 1.5 cm
  • Airway abnormalities
  • Surgery in respiratory tract

结局指标

主要结局

Seal pressures

时间窗: six months

The primary objective is to determine the effectiveness of the seal pressure between the mask COOKGAS ™ and LMAc in patients undergoing outpatient surgeries in ambulatory-based IPS, University of Antioquia (institution services health clinic) located in the city of Medellin.

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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