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
适应症
干预措施
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
- 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
研究组 & 干预措施
Cookgas
Active Comparator
This group will be assigned to use cookgas mask
干预措施: cookgas mask (Device)
LMA mask
Active Comparator
This group will be assigned to use LMA mask
干预措施: LMA mask (Device)
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
研究点 (1)
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