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临床试验/NCT02979171
NCT02979171已完成4 期

Comparison in Difficult Airway Scenario Induced in Patients With Laryngeal Mask Airway (LMA)-Classic™, LMA™ - Flexible and LMA - Proseal™

Marmara University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
90
试验地点
1
主要终点
insertion time and attempts in min.

研究概览

简要总结

Supraglottic airway tools, one of the tools used in the management of the difficult airway. American Society of Anesthesiologists and the Difficult Airway Society of the United Kingdom airway management algorithms have included the LMA. In our study investigators aimed to determine which one will show the best performance with supraglottic airway means that LMA - Classic, LMA - Flexible and LMA - ProSeal in patients that difficult airway scenarios created with attaching collar.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Without a history of difficult intubation, supine position, does not require tracheal intubation, undergo elective surgery

排除标准

  • •High aspiration risk, who take more than 4 hours surgery
  • •Body mass index greater than of 35 kg/m²
  • •Disease related to the cervical spine
  • •The mouth opening is less than 20 mm

研究组 & 干预措施

LMA-Classic

Active Comparator

airway management with LMA-Classic

干预措施: Laryngeal Mask Airway Classic (Device)

LMA-Flexible

Active Comparator

airway management with LMA-Flexible

干预措施: Laryngeal Mask Airway Classic (Device)

LMA-Proseal

Active Comparator

airway management with LMA-Proseal

干预措施: Laryngeal Mask Airway Classic (Device)

结局指标

主要结局

insertion time and attempts in min.

时间窗: through study completion, an average of 6 months

oropharyngeal leak pressure in cmH20.

时间窗: through study completion, an average of 6 months

fiberoptic view grade by Brimacombe and Berry bronchoscopy score

时间窗: through study completion, an average of 6 months

score1-4 (easy to difficult)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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