NCT02140008已完成不适用
A Comparison of the I-gel and the Self-pressurised Air-Q Intubating Laryngeal Airway in Children
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- airway leak pressure
研究概览
简要总结
Supraglottic airway devices (SADs) are well established in pediatric anesthetic practice. The pediatric i-gel and the self-pressurised air-Q (air-Q) are new supraglottic airway devices for children. The i-gel is made of a soft, gel-like elastomer with a noninflatable cuff. The air-Q is a new single-use device that may optimise the airway seal while reducing the potential for postoperative complications such as sore throat. The overall structure of the air-Q SP is identical to the original air-Q, except with regard to the inflatable cuff. The aim of this randomized trial was to compare the clinical performance of the i-gel and the air-Q SP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 108 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children (1-108 month of age and 7-30kg) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway
排除标准
- •Patients with a potentially difficult airway, risk of aspiration such as gastroesophageal reflux disease, or active upper respiratory tract infection
结局指标
主要结局
airway leak pressure
时间窗: within 5 min after insertion of each device
次要结局
- Insertion time (insertion parameter)(During and 1 min after insertion of each device)
研究者
研究点 (2)
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