The New Laryngeal Tube Suction-Disposable for Childrens. An Observational Study
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 主要终点
- Seal pressure in cm H2O
研究概览
简要总结
The Laryngeal Tube Suction Disposable( LTS-D) has recently undergone considerable structural changes in design. As these changes may influence the performance of the LTS-D relative to the old LTS-D version the investigator decided to check the new LTS-D in the pediatric version The investigator hypothesized that the LTS-D perform clinically well during general anesthesia with controlled ventilation.
详细描述
The LTS-D, is a second generation supraglottic airway device, made from the medical polyvinyl chloride introduce in 2005. It is used for maintaining the airway during spontaneous and controlled ventilation during general anesthesia . It has been advocated for prehospital emergency airway management and serves as a useful tool during failed intubations The LTS-D has recently undergone considerable changes in design based on clinical studies and investigators feedback. The new LTS-D is available to adult and pediatric sizes.For childrens the devices is presented in the size 3 for patients of < 155 cm (> 30 Kg.), the size 2.5 for patients 125-150cm. (20-30 Kg.), the size 2 for patients of 12-25 Kg, the size 1 for patients of 5-12 Kg and the size 0 for patients < 5 Kg.
As these changes may influence the performance of the LTS-D relative to the old LTS-D version the investigator decided to check the new LTS-D in the pediatric version.
The investigator hypothesized that the LTS-D perform clinically well during general anesthesia with controlled ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients, ASA I and II, normal airway, for minor elective surgery
排除标准
- •Weigth <10Kg or > 30 Kg, known difficult airway, active esophagial reflux
结局指标
主要结局
Seal pressure in cm H2O
时间窗: one minute
We will measure the seal leak pressure at 60 cm H2O intracuff pressure and the minimal pressure of the cuff to performed effective volume controlled ventilation
次要结局
- Time of insertion in seconds(one minute)
研究者
LUIS.GAITINI
M.D.
Bnai Zion Medical Center