A Comparative Randomized Prospective Study Between the New Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Pediatric Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Leak pressure measure in cm H2O
研究概览
简要总结
The study compared the Laryngeal Tube Suction Disposable (LTS-D) with the Disposable Laryngeal Mask Ambu® AuraGain™ (DLMA AG) during general anesthesia in pediatric patients.
The investigators hypothesized that the LTS-D and the DLMA AG performed similarly during mechanical ventilation despite differences in their structural design.
详细描述
The Laryngeal Tube Suction-Disposable (LTS-D, (VBM Medizintechnik GmbH, Sulz, Germany), is a second generation single-use supraglottic airway devices (SADs) with gastric access, for airway management in spontaneously and mechanically ventilated patients undergoing general anesthesia.
The AuraGain is a second generation laryngeal mask, satisfying airway management needs by integrating gastric access and ventilation capability in an anatomically curved single-use device that facilitates rapid establishment of a safe airway.
The two devices have now pediatric sizes.
To date, there is no published data comparing the LTS-D and the DLMA AG during mechanical ventilation in pediatric patients. The investigators hypothesized that the LTS-D and the DLMA AG perform similarly during mechanical ventilation despite differences in their structural design.
The chief aim of this prospective randomized study was to compare the LTS-D and the DLMA AG with respect to:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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, American Society of Anesthesiologist (ASA) physical status I and II weighing 30 to 10 kg, posted for abdominal surgery under general anesthesia.
排除标准
- •Infants with active respiratory tract infection anticipated and known difficult airway, lung disease requiring high positive end expiratory pressure, and active gastrointestinal reflux will be excluded.
研究组 & 干预措施
Laryngeal Tube Suction Disposable
Laryngeal Tube Suction Disposable for ventilation
干预措施: Laryngeal Tube Suction Disposable (Device)
Laryngeal Mask Airway AuraGain
Laryngeal Mask Airway AuraGain for oxygenation and ventilation
干预措施: Laryngeal Mask Airway AuraGain (Device)
结局指标
主要结局
Leak pressure measure in cm H2O
时间窗: 60 seconds
次要结局
- Time to insertion a device in seconds(60 seconds)
研究者
LUIS.GAITINI
medical doctor
Bnai Zion Medical Center