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临床试验/NCT04365192
NCT04365192已完成不适用

Comparison of Efficacy of Two Supraglottic Airway Devices: I-gel and the Self-pressurized Air-q in Elderly Patients

Istanbul Medeniyet University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Success in first attempt

研究概览

简要总结

Supraglottic airway devices with noninflatable cuff have advantages in omitting the cuff pressure monitoring and reducing potential pharyngolaryngeal complications. Typical devices without cuff inflation available are the i-gel™ and the self-pressurized air-Q™ intubating laryngeal airway (air-Q SP).

The i-gel airway is a supraglottic airway management device made of thermoplastic elastomer, which is soft, gel-like, and transparent. It was designed to create a noninflating anatomical seal of the pharyngeal, laryngeal, and perilaryngeal structures while avoiding the compression trauma that can occur with inflatable SADs.

The i-gel has evolved as a device that accurately positions itself over the laryngeal framework, providing a reliable perilaryngeal seal, and therefore no cuff inflation is necessary. Its advantages include easier insertion, minimal risk for tissue compression, and stability after insertion.

The air-Q is a new SAD intended for use as a primary airway and an aid for tracheal intubation in situations of anticipated or unanticipated difficult airways. The intracuff pressure of air-Q dynamically equilibrates with the airway pressure and adjusts to the patient's pharyngeal and periglottic anatomy, potentially providing improved airway fit and seal.

The anatomical and physiological changes that accompany ageing may have a significant influence on the efficacy and safety of SADs. The distinctive features of the air-Q SP and i-gel may lead to a substantial difference in performance in the elderly, and it is planned a head-to-head comparison of these two devices in patients aged between 65 and 85 years.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 65-85 years old
  • ASA I-III
  • Elective urologic surgery
  • Mallampati 1-2

排除标准

  • BMI>35kg/m2
  • Operation time more than 2 hours

结局指标

主要结局

Success in first attempt

时间窗: 3 minutes

Correct insertion was assessed by proper chest expansion, the presence of a CO2 wave form with a plateau on the capnograph, absence of audible leak, and lack of gastric insufflation.

次要结局

  • Fiberoptic view grade(4 minutes)

研究者

发起方
Istanbul Medeniyet University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ferda Yilmaz Inal

assistant professor

Istanbul Medeniyet University

研究点 (1)

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