NCT01625078已完成2 期
Observational Study of Baska Mask, a New Supraglottic Airway Device in Children
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- John Laffey
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Device insertion success rate
研究概览
简要总结
The investigators wish to accumulate initial data on the performance and safety of the Baska mask in paediatric patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 15-35
- •weight over 30kg or age 8-16 yrs
- •non-urgent surgery of planned duration up to 2 hrs
排除标准
- •neck pathology
- •previous or anticipated problems with the upper GI or upper airway
- •increased risk of gastric aspiration
- •expected difficult airway
研究组 & 干预措施
Baska mask
Experimental
干预措施: Placement and use of Baska mask (Device)
结局指标
主要结局
Device insertion success rate
时间窗: within 30 minutes of induction of general anesthesia
device airway leak pressure
时间窗: within 10 minutes of successful device placement
the airway l;eak pressure is defined as the plateau airway pressure measured while the patient is apnoeic with the APL valve of the anaesthetic machine set to 35 cm H2O and the fresh gas flow set to 6 L/min
次要结局
- airway stability(within 30 minutes of device placement)
- ease of device placement(within 30 minutes of induction of general anesthesia)
- complications during the anesthetic(from the start of device insertion untill discharge from recovery, an expected average of 2 hours)
研究者
John Laffey
Professor of Anaesthesia and Critical Care
University College Hospital Galway
研究点 (1)
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