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: 2011年4月22日

适应症

试验速览

阶段: 3 期
发起方: Universidad de Antioquia
入组人数: 106
试验地点: 1
主要终点: Seal pressures

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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: 否

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

发起方

Universidad de Antioquia

申办方类型

Other

研究点 (1)

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