跳至主要内容
临床试验/NCT01625078
NCT01625078已完成2 期

Observational Study of Baska Mask, a New Supraglottic Airway Device in Children

John Laffey1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年3月最近更新:
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

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

发起方
John Laffey
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

John Laffey

Professor of Anaesthesia and Critical Care

University College Hospital Galway

研究点 (1)

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