A RANDOMIZED CONTROLED TRAIL COMARING LARYNGEAL TUBE SUCTION DISPOSABLE AND I-gel IN PEDIATRIC PATIENT
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Seal pressure
研究概览
简要总结
Introduction The Laryngeal Tube Suction Disposable LTS-D and the i-gel are a second generation supraglottic airway device SAD, the devices have a drain tube to allow access to the gastrointestinal.
The i-gel is a second generation SAD. Does not need an inflatable cuff because the thermoplastic elastomer provides the seal.
The study designs to compare the Oropharyngeal leak pressure (OLP) of LTS-D with the i-gel that allow the use of Pressure Control Ventilation.
Materials and methods Approval obtained from the institute Ethics Committee, No 0117-22-BNZ. Written parental consent will be obtained Hundred children (50 patients in each device of both sex, weighing 10-35 kg, with an ASA physical status I, scheduled for elective minor surgery Study design Devices are the pediatric LTS-D and the i-gel. The patients will fast for 6 h for solids and 2 h for clear fluids and will be unpremeditated, anesthesia will initiate following a standardized protocol.
Both devices will be inserted blindly by expert pediatric anesthesiologists. Leak pressure, will be determined by closing the expiratory valve of the anesthesia breathing system and a fixed gas flow of 3 l min-1. The airway pressure at which an equilibrium is reached will be noted (maximum 40 cm H2O).
Primary outcome: Leak pressure Secondary outcome: SGAD insertion time Fiberoptic view Maneuvers Complications. Statistical Analysis the primary outcome is the leak pressure. Previous pilot conducted in 15 children, the average standard deviation leak pressure found to be 31 cm H20. In order to obtain a statistically representative sample for a 95% CI with a margin error of 2% and a standard deviation of 2 cm H20, the sample sizes of 50 cases are needed for each device.
Continuous data presented as mean±SD. For the categorical variables frequencies and percentages will be calculated. SPSS version 20 for statistical analysis. P-values smaller than 0.05 considered statistically significant.
Categorical data will be analyzed with Pearson chi-square test Mann-Whitney U test will be performed to analyze non-normally distributed interval scale data and ordinal categorical data. Normally distributed data will be analyzed by t-tests.
详细描述
Introduction The Laryngeal Tube Suction Disposable LTS-D and the i-gel are a second generation supraglottic airway device (SGA). A device have a drain tube to allow access to the gastrointestinal tract.
The LTS-D has recently undergone considerable changes in its design based on clinical studies users' feedback. It is available in all sizes, from newborn to adult.
The ventilation section between the proximal and distal cuff is significant different to the previous LTS-D. The ramp is conically shaped and increases space approximately 25% in the hypopharynx.
The i-gel is a second generation SAD, disposable airway is a SAD made of a medical grade thermoplastic elastomer. Its unique design does not need an inflatable cuff because the thermoplastic elastomer provides the seal. The i-gel is gaining a reputation for its ease of insertion and for its use in many clinical situations.
For our knowledge there are no published studies comparing the performances of the improved LTS-D and the i-gel in pediatric patients .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ELECTIVE SURGRY
排除标准
- •ASA II OR MORE
- •At risk for aspiration
- •Upper respiratory tract symptoms within former 10 days
- •Congenital anatomical malformation
- •A possible difficult airway by history or physical examination.
结局指标
主要结局
Seal pressure
时间窗: 60 seconds
Measuring seal pressure
次要结局
- Device Insertion(30 seconds)
研究者
MOSTAFA.SOMRI
Associate Clinical Professor of Anesthesiology
Bnai Zion Medical Center