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临床试验/NCT02260427
NCT02260427已完成不适用

A Comparison of the I-gel and Self-pressurised Air-Q Intubating Laryngeal Airway (Air-Q sp) in the Elderly Patients

Yonsei University2 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
airway leak pressure measured after device insertion

研究概览

简要总结

Supraglottic airway devices (SADs) are well established in anesthetic practice. Among these devices, the i-gel has been typically widely used. The self-pressurised air-Q intubating laryngeal airway (air-Q sp) is newly developed supraglottic airway devices. It is a new single-use device that may optimise the airway sealing while reducing the potential for postoperative complications such as sore throat. The overall structure of the air-Q sp is similar to the original air-Q, except the inflatable cuff. The aim of this randomized trial was to compare the clinical performance of the i-gel and the air-Q sp in elderly patients

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
65 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • elderly adult patients (65-90 of age) scheduled for elective surgery 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 measured after device insertion

时间窗: within 5min after insertion of each device

Airway leak pressure was determined by adjusting the expiratory valve of the breathing circle to 40 cmH2O (fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached.

次要结局

  • insertion parameters (insertion time and ease of insertion)(During and 1 min after insertion of each device)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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