Effectiveness of the New Perilaryngeal Airway (CobraPLA™) in Comparison With the Laryngeal Mask Airway (LMA™) to Improve Oropharyngeal Leak Pressure Among Obese and Overweight Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 74
- 主要终点
- Time to intubation
研究概览
简要总结
The Laryngeal Mask Airway (LMA) has been used widely for different patients and found to be highly safe for adult and pediatric patients. However, the LMA has some limitations and weaknesses (e.g. more insertion attempts in 5% to 10 % of all cases. Despite the easy insertion of the LMA, it is crucial to check correct placement of the LMA airway.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •BMI between 25 to 35 kg/m2
- •scheduled for surgery
- •being older than 18 years
- •Mallampati class I-III and BMI between 25 and 35
排除标准
- •pregnancy
- •morbid obese (BMI>35 kg/m2)
- •a known difficult airway
- •gastro-oesophageal reflux
- •pharyngeal pathology
- •emergency operation with full stomach
研究组 & 干预措施
CobraPLA
Patients will randomly assign to either LMA or Cobra PLATM
干预措施: COBRA (Device)
LMA
Patients will randomly assign to either LMA or Cobra PLATM
干预措施: LMA (Device)
结局指标
主要结局
Time to intubation
时间窗: Up to 1 hours
Time to intubation was measured from inserting of the device to the patient's month while connecting the breathing circuit
Oropharyngeal leak
时间窗: Up to 1 hours
次要结局
- incidence of postoperative blood staining on mask(Up to 1 hours)
- successful intubation attempt(Up to 1 hours)
- incidence of sore throat(Up to 1 hours)
- incidence of dysphasia(Up to 1 hours)
研究者
Amir H Pakpour
Assistant Professor, Department of Public Health, Qazvin University of Medical Sciences, Qazvin, Iran.
Qazvin University Of Medical Sciences