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临床试验/CTRI/2017/10/010242
CTRI/2017/10/010242已完成不适用

Comparison between macintosh laryngoscope and king vision Video laryngoscope, for intubation in cervical Spine injured patients, with manual-in-line-axial stabalization

Indian Spinal Injuries Centre1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2015年1月8日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Intubation Difficultly Scale Score

研究概览

简要总结

Primary Purpose

Intubation procedure in any patient,  with Conventional Macintosh Laryngoscope, requires movement of neck and alignment of oro-pharyngo-laryngeal axis in straight line. This manuever  in some cases of cervical injury,  may lead to deterioration of neurological status of patient. Or on the other hand, if neck is immobilised, intubation becomes difficult, which may lead to life threatening complications.

So, the purpose of conducting this study was to evaluate the ease, safety and efficacy of KingVision Video laryngoscope in intubating cervical injury patients with neck immobilisation vis a vis the conventional Macintosh Laryngoscope (which is the most common, and versatile laryngoscope in use till date)

Hypothesis

We hyothesise that intubation with KingVision Videolaryngoscope because of its specific shape and a channel to carry the tube, will be easier and safer than the conventional Macintosh Laryngoscope, in cases of cervical injury patients, with neck immobilisation with MILS technique.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients of cervical spine injury 2.ASA grade 1 to 3 3.Posted in the Operation Theatre for cervical spine fixation.

排除标准

  • 1.Difficult airway due to reduced mouth opening <5cm 2.Anatomical abnormalities such as congenital anomalies 3.Trauma to airway, broken teeth, blood in airway making direct laryngoscopy difficult 4.Patients who required Rapid sequence intubation 5.Those who were on ionotropic or vasopressor support.

结局指标

主要结局

Intubation Difficultly Scale Score

时间窗: Easy less than 1 | Moderate 1 to 5 | Difficult more than 5

次要结局

  • Duration of Intubation(Seconds)
  • Mean Arterial Pressure(Before intubation)
  • Heart Rate(Before intubation)
  • Complications(Tooth injury)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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