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临床试验/NCT02532465
NCT02532465已完成不适用

Glottic View Using Supraglottic Devices in Pediatric Patients

Senthil G. Krishna1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Acceptable View of the Glottic Aperature (Grade I-II)

研究概览

简要总结

Endotracheal intubation is the gold standard for securing the airway. However, while managing patients with difficult airways, various supraglottic devices have been used as rescue airway devices. The aim of this study is to compare the fiberoptic view through the internal aspect of the i-gel versus the Air-Q LMA in pediatric patients. By examining the fiberoptic view through these two devices, the investigators will determine which device provides a clearer passage to the glottic opening and is therefore the preferred conduit to aid endotracheal intubation in difficult airways.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients less than 18 years of age who will be receiving an LMA as part of standard of care for their procedure.

排除标准

  • 未提供

研究组 & 干预措施

Air-Q

Active Comparator

The Air-Q is composed of an airway tube that connects to an elliptical mask with a cuff which is inserted through the patient's mouth, down the windpipe, and once deployed forms an airtight seal on top the glottis (unlike tracheal tubes which pass through the glottis) allowing a secure airway to be managed by a health care provider.

干预措施: Air-Q (Device)

i-gel

Experimental

The i-gel is designed to create a non-inflatable anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures whilst avoiding the compression trauma that can occur with inflatable supraglottic airway devices.

干预措施: i-gel (Device)

结局指标

主要结局

Acceptable View of the Glottic Aperature (Grade I-II)

时间窗: 15 seconds after insertion of Air-Q or i-gel

Grade I view - Glottic aperture seen completely without any obstruction, Grade II view - Glottic aperture seen only partially but visual obstruction is less than 50%.

次要结局

  • Airway Insertion Time(Immediately after anesthesia induction)
  • Time to Achieve Best Fiberoptic View(15 seconds after insertion of Air-Q or i-gel)

研究者

发起方
Senthil G. Krishna
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Senthil G. Krishna

Assistant Clinical Professor

Nationwide Children's Hospital

研究点 (1)

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