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临床试验/NCT02250521
NCT02250521已完成不适用

McGRATH MAC Video Laryngoscope - To View or Not To View?

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014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
入组人数
100
试验地点
2
主要终点
Number of Participants Successfully Intubated on First Attempt With Use of Either a Direct or Indirect Laryngoscopic View

研究概览

简要总结

This study was designed to determine the first attempt success rate of tracheal intubation with the McGRATH™ MAC laryngoscope using direct visualization in patients with known difficult airways, as well as exploring the possibility of identifying a particular direct Cormack-Lehane (C-L) grade view where indirect (video) visualization can be most beneficial during laryngoscopy and intubation.

研究设计

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

入排标准

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

入选标准

  • BMI < 50 kg/m2
  • Two or more of the following inclusion criteria: Mallampati class: III-IV; Reduced mouth opening < 4 cm; Neck circumference > 40 cm for females and > 43 cm for males; Thyromental distance < 6 cm; Ratio of the patient's height to thyromental distance ≥ 23.5; Sternomental distance < 12 cm

排除标准

  • BMI ≥ 50 kg/m2
  • emergency status
  • cervical injury or pathology
  • neck irradiation
  • known difficult airway
  • risk of gastric aspiration
  • hemodynamic instability
  • requiring rapid sequence intubation

研究组 & 干预措施

McGrath Mac intubations

Experimental

All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The liquid crystal display (LCD) monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.

干预措施: McGrath MAC enhanced direct laryngoscope (Device)

结局指标

主要结局

Number of Participants Successfully Intubated on First Attempt With Use of Either a Direct or Indirect Laryngoscopic View

时间窗: after successful endotracheal tube placement

All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.

次要结局

  • Glottic View With Direct Laryngoscopy(at the time of laryngoscopy)
  • Glottic View With Indirect Laryngoscopy(at the time of laryngoscopy)
  • Number of Participants on Whom Bougie (Introducer) Was Used to Facilitate Intubation on the First Attempt(at the time of intubation)
  • Time for Intubation(at the time of laryngoscopy)
  • Number of Intubation Attempts(at the time of intubation)
  • Time for Indirect View Laryngoscopy During the First Attempt(at the time of laryngoscopy)
  • Number of Participants Who Received External Laryngeal Manipulation During the First Attempt(at the time of intubation)
  • Time for Direct View Laryngoscopy During the First Attempt(at the time of laryngoscopy)
  • Subjective Ease of Laryngoscopy(at the time of laryngoscopy)
  • Subjective Ease of Intubation(at the time of laryngoscopy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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