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临床试验/NCT03341507
NCT03341507已完成不适用

A Comparative Study Between the Rigid Tube for Laryngoscopy, as a New Tool for Tracheal Intubation, and McIntosh Laryngoscope in Difficult Airway Patients

Iuliu Hatieganu University of Medicine and Pharmacy2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2017年2月1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
64
试验地点
2
主要终点
Time to Tracheal Intubation With the Rigid Tube

研究概览

简要总结

This study evaluates the efficiency of the rigid tube for laryngoscopy for tracheal intubation in patients with presumed difficult airway and compare the classical laryngoscopy and this method in matter of glottis visualisation and tracheal intubation.

详细描述

The rigid tube for laryngoscopy is a 15 to 30 cm long metallic tube with a bevel end and a diameter of 0.5-2.0 cm , an instrument used to inspect the larynx and surrounding areas. It resembles a rigid bronchoscope but it is shorter. When in use, it has to be attached to a light source.

The hypothesis of the study stands that the rigid tube for laryngoscopy could be more efficient in tracheal intubation for difficult airway patients when the classical intubation with a curved blade laryngoscope is unsatisfactory.

The retromolar approach in both sides together with bougie(intubating tube introducer) intubation is the technique of intubation used in this study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with criteria of anatomically difficult airway from SARI (The Simplified Airway Risk Index Scale) parameters analysis
  • patients with airway pathology which predicted difficult intubation: tumors or cervical masses, previous radiotherapy or surgery

排除标准

  • stridor or marked laryngeal or tracheal stenosis, vocal cords polyps
  • emergency surgery, decompensated cardiac or pulmonary disease
  • grade 1 and 2a at classical laryngoscopy after Cormack- Lehane Classification

结局指标

主要结局

Time to Tracheal Intubation With the Rigid Tube

时间窗: 120 seconds

the time from starting to use the rigid tube for laryngoscopy until the airway was secured.

次要结局

  • Complications During Intubation With Rigid Tube(5 minutes)
  • Late Complications of Intubation With Rigid Tube(3 days)

研究者

发起方
Iuliu Hatieganu University of Medicine and Pharmacy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marchis Ioan Florin

Principal Investigator

Iuliu Hatieganu University of Medicine and Pharmacy

研究点 (2)

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