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临床试验/NCT02926144
NCT02926144已完成不适用

Can the Use of the McGRATH® MAC Videolaryngoscope Decrease the Number of People Required for Tracheal Intubation in a Population of Patients Without Predicted Difficult Intubation?

Hopital Foch4 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2016年11月28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
发起方
Hopital Foch
入组人数
300
试验地点
4
主要终点
Number of people needed for tracheal intubation when the video feature of McGRATH® MAC videolaryngoscope is available

研究概览

简要总结

The main objective of this study is to compare the proportion of tracheal intubations for which more than one person is necessary when using the McGRATH® MAC videolaryngoscope.

详细描述

Videolaryngoscopes, such as McGRATH® MAC videolaryngoscope, are used to facilitate tracheal intubations. This study is designed to evaluate the proportion of cases requiring more than one member of the anesthesiology team when the video feature of McGRATH® MAC is available during laryngoscopy in a population of patients without a predicted difficult intubation (Arne's score <11).

General anesthesia from induction until tracheal intubation is recorded on a video for further analysis. Analysis includes characteristics of intubation, patient's monitoring and cooperation between anesthesiologists in two groups. In the control group, the screen of the McGRATH® MAC videolaryngoscope is hidden. In the experimental group, the McGRATH® MAC videolaryngoscope is used with its video feature.

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 (Outcomes Assessor)

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

  • Aged 18 years old minimum
  • Requiring general anesthesia and orotracheal intubation with a single lumen tube
  • Having signed an inform consent form
  • Having a telephone and agreeing to communicate their phone number
  • Benefiting from a social insurance scheme or beneficiary

排除标准

  • Pregnant or breast-feeding women
  • Patients taken care in ambulatory surgery who could not be contacted within 24 hours following surgery
  • Patients having a predicted difficult intubation (Arné's score ≥ 11) or predicted difficult mask ventilation
  • patients requiring a rapid-sequence intubation
  • patients for whom general anesthesia using sufentanil, propofol, atracurium or rocuronium is not suitable.

研究组 & 干预措施

Laryngoscope with video

Experimental

Use of the video-laryngoscope McGrath Mac with use of the video feature

干预措施: Laryngoscope with video (Device)

Laryngoscope without video

Active Comparator

Use of the video-laryngoscope McGrath Mac without use of the video feature

干预措施: Laryngoscope without video (Device)

结局指标

主要结局

Number of people needed for tracheal intubation when the video feature of McGRATH® MAC videolaryngoscope is available

时间窗: 30 minutes

Intubation is video and audio recorded for further analysis. The availability of the video feature of McGRATH® MAC is hidden from the recording. Only the number of people required and the intubation characteristics can be seen on the video.

次要结局

  • Cooperation between members of the anesthesiology team during intubation(30 minutes)
  • Intubation difficulty Scale (IDS)(30 minutes)
  • Number of hands necessary for tracheal intubation(30 minutes)
  • Time to intubate(30 minutes)
  • Esophageal intubation(30 minutes)
  • Intubation failure(30 minutes)
  • Arterial desaturation(30 minutes maximum)
  • Perception of intubation difficulty by the operator(30 minutes)
  • Impact of videolaryngoscopy on hemodynamic variables(30 minutes)
  • Evaluation of usual complications after tracheal intubation(24 hours)

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

研究点 (4)

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