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临床试验/NCT03115606
NCT03115606已完成不适用

Comparison of C-Mac D Blade and Fastrach Laryngeal Mask Airway on Cervical Spine Motion Conditions in Cervical Discectomy

Diskapi Teaching and Research Hospital2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2017年3月24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
入组人数
52
试验地点
2
主要终点
Angle A (degree), Angle B (degree), Angle C(degree)

研究概览

简要总结

In patients with cervical spine disorders or hernia, in-line stabilization and immobilization during tracheal intubation is used to avoid neck injury. With direct laryngoscopy cranio-cervical motion can result injury. The aim of the study is to compare two different device (C-Mac D blade versus fastrach LMA ) regarding cervical motions during intubation.

详细描述

In simulated or clinical settings of restricted neck mobility, videolaryngoscopes and fastrach LMA have performed well but neck motion can be occured. Endotracheal intubation will be performed under fluoroscopy. In this study the neck motion angles will be investigated during intubation . The angles will be assessed on fluoroscopy images. A Angle: Angle of the line between occipital protuberance and anterior process of the foramen magnum with the line between central point of spinous process C1 vertebrae and the anterior process of foramen magnum. The reference line for the occiput is defined as a line between the base of the sella and the opisthion (lineA), and the C1 reference line as a line between the lower cortical margin of the spinous process (line B). The C2 reference line is defined as a line between the anterior , inferior margin of the C2 body and the lower cortical margin of the C2 spinous process (lineC). The C5 reference line is a tangent along the superior endplate of the C5 vertebral body (line D). The groups will be compared statistically.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of cervical disc herniation ( scheduled cervical discectomy)
  • American Society of Anesthesiology (ASA) physical status I-III patients

排除标准

  • ASA IV patients
  • Age under 18 years, over 70 years
  • Hepatic disease
  • Renal disease
  • Cardiac disease
  • Anticipated difficult airway

研究组 & 干预措施

Videolaryngoscope

Active Comparator

Patients intubated with C-Mac D Blade Videolaryngoscope

干预措施: C-Mac D Blade (Device)

Fastrach LMA

Active Comparator

Patients intubated with Fastrach LMA

干预措施: Fastrach LMA (Device)

结局指标

主要结局

Angle A (degree), Angle B (degree), Angle C(degree)

时间窗: 30 second

Angle of the line between occipital protuberance and central point of spinous process of C1 vertebrae. Angle B and Angle C (degree)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

derya özkan

Associated professor

Diskapi Teaching and Research Hospital

研究点 (2)

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