Comparison of the I-gel Laryngeal Mask and the Classic Laryngeal Mask in Patients With a BMI>25
Comparison of the I-gel Laryngeal Mask and the Classic Laryngeal Mask in Patients With a BMI>25 During Elective Surgery
研究概览
详细说明
Inclusion criteria of this randomized cross-over study are: BMI > 25, elective surgery in supine position, age>18 years, ASA I-II; Exclusion criteria are: difficult airway, pregnancy, history of reflux or gastrointestinal disorders, abdominal or thoracic surgery; In this cross-over trial both airway devices are inserted in the same patient, the order of insertion is randomized. Patient receive monitoring with blood pressure, ECG and pulse oxymetry during operation. Anaesthesia is induced intravenously using fentanyl (0.001 mg/kg) and propofol (3-5 mg/kg). The I-gel laryngeal mask is inserted with a gastric tube. The classic laryngeal mask was cuffed after insertion with a cuff pressure of 60 cmH2O. The first device is removed 5 minutes after insertion and replaced by the second device. Ease of insertion is graded as very easy=1, easy=2, difficult=3 and very difficult=4. Leak pressure is measured by two tests: In the first test the spill valve is closed at a fresh gas flow of 6l/min and the minimum airway pressure at which gas leaked around the airway device is recorded by listening for an audible leak. In the second test leakage is measured during pressure controlled ventilation. Therefore we administer a fresh gas flow of 3l/min, FiO2 of 50%, inspiration to expiration ratio of 1:2 and a frequency of breathing of 12. Leakage can be measured by the respirator. We record inspiration pressure, mean pressure, plateau pressure, tidal volume and peep at which the first measurable leakage occurred.
For statistical analysis we will use t-tests with a power of 80% and a p < 0.05.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Vienna、奥地利、1090
- Medical university of vienna, General hospital of Vienna
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- BMI > 25, elective surgery in supine position,
- age > 18 years,
- ASA I-II;
Exclusion Criteria:
- difficult airway, pregnancy,
- history of reflux or gastrointestinal disorders,
- abdominal or thoracic surgery;
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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其他:I-gel inserted first
The I-gel airway is insewrted first, then the LMA-Unique
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intubation with I-gel airway
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其他:LMA-Unique inserted first
LMA-Unique airway is inserted first, then the I-gel
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LMA-Unique airway is inserted first, then the I-gel
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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leak pressure of the laryngeal masks
大体时间:directly after insertion of the laryngeal mask
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directly after insertion of the laryngeal mask
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次要结果测量
结果测量 |
大体时间 |
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Insertion time and ease of insertion of the laryngeal mask
大体时间:during insertion of the laryngeal mask
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during insertion of the laryngeal mask
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 354/2009
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I-gel的临床试验
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Geneve TEAM AmbulancesUniversity Hospital, Geneva; ESAMB - College of Higher Education in Ambulance Care; Ambulances...完全的
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Seoul National University Hospital完全的
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Geneve TEAM AmbulancesService de protection et sauvetage Lausanne (SPSL), Emergency Medical Services, Switzerland; Ambulance Riviera, Emergency Medical Services, La Tour-de-Peilz, Switzerland 和其他合作者完全的