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临床试验/NCT02286570
NCT02286570已完成4 期

Face-to-face Tracheal Intubation With Fastrach or Videolaryngoscopes

Kocaeli University0 个研究点目标入组 120 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
120
主要终点
intubation time

研究概览

简要总结

Trauma victims had to be intubated at the scene of area in different conditions. Face-to-face intubation in an entrapped patient is one of these situations. The investigators want to compare the efficacy of Glidescope, Airtraq and Fastrach in simulating face-ro-face intubation in adult patients aged between 18-60 years.

详细描述

The investigators record the demographic and the airway data of the patients (thyromental distance, sternomental distance, mallampati score, mandibula protrusions, interincisor distance..etc). The hemodynamic data of the patients baseline preoperatively, after induction, after insertion of the device, after intubation, and 2 minutes intervals after intubation during the ten minutes. Cormack-Lehane grade of the videolaryngoscopes, insertion time, intubation time, need of optimisation maneuvers, mucosal damage, teeth and tongue damage, postoperative sore throat, hoarseness, dysphagia were recorded.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-60 years of age
  • Elective surgery requiring endotracheal intubation
  • Normal airway variables

排除标准

  • < 18 years or > 60 years
  • Emergency procedures
  • Known difficult airways

结局指标

主要结局

intubation time

时间窗: elapsing between the handling of the device till intubation 2 minutes

2 minutes

次要结局

  • hemodynamic changes (mean arteriial pressure)(entübation and after 15 minutes)
  • postoperative minor complications sore troat, teeth damage, tongue damage, desaturation, hoarseness, disphagia(sore troat, teeth damage, tongue damage, desaturation, hoarseness, disphagia 30 minutes)
  • mucosal damage(blood on the device after removal 1 minute)
  • need of optimisation maneuvers(chandy, side-to-side, handling force, up-down, reinserting 15 minutes)

研究者

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

Zehra Ipek ARSLAN

Assistant Professor

Kocaeli University

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