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临床试验/NCT06322719
NCT06322719招募中不适用

A Randomized Comparison Between the Hyperangulated vs. Macintosh Blades for First-attempt Intubation Success With Videolaryngoscopy in ICU Patients.

Hospital Clinico Universitario de Santiago48 个研究点 分布在 1 个国家目标入组 1,036 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,036
试验地点
48
主要终点
Difference in the first attempt intubation success rate (percentage)

研究概览

简要总结

Tracheal intubation in the intensive care unit (ICU) is associated with high incidence of difficult intubation and complications. Videolaryngoscopes (VLs) devices have been proposed to improve airway management, and the use of VLs are recommended as first-line or after a first-attempt failure using direct laryngoscopy in ICU airway management algorithms. Although until relatively few years ago there were doubts about whether videolaryngoscopes had advantages over direct laryngoscopy for endotracheal intubation (ETI) in critically ill patients, two recent studies (DEVICE (1), INTUBATE (2)), and a Cochrane review (3) have confirmed that videolaryn should be used?, and what is the best blade? . There are two types of blades commonly used with videolaryngoscopes: the "Macintosh" blade with a slight curvature, and hyperangulated blades. The "Macintosh" blades have a lower angle of vision, but they have the advantage of being similar to the blades commonly used in direct laryngoscopy, making them easy to use for the person performing the ETI. Hyperangulated blades have a greater angle of vision, improving glottic visualization, especially in patients with an anterior glottis. However, the need to overcome this angulation could potentially hinder the passage of the endotracheal tube to the vocal cords. It is unknown if either blade has any advantage for intubating critically ill patients.

详细描述

The purpose of this prospective multicenter randomized study is to compare successful intubation on the first attempt with the Macintosh videolaryngoscope vs the hyperangulated videolaryngoscope during tracheal intubation in ICU patients.The hypothesis of the study is that tracheal intubation using the hyperangulated videolaryngoscope will improve the frequency of successful intubation on the first attempt in ICU patients requiring intubation in the intensive care unit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or older.
  • Admitted to an Intensive Care Unit.
  • Need for tracheal intubation during the stay in the ICU.
  • The device to be used for intubation is a videolaryngoscope

排除标准

  • Pregnancy or lactation.
  • Emergent tracheal intubation that does not allow for the randomization of the procedure.
  • Need for tracheal intubation with a device other than the videolaryngoscope (fiberoptic bronchoscope, direct laryngoscopy, tracheostomy, etc.).
  • Tracheal intubation performed outside the ICU (Emergency Department, Hospital ward, etc.).

结局指标

主要结局

Difference in the first attempt intubation success rate (percentage)

时间窗: During intubation (minutes)

The primary outcome is defined as placement of an endotracheal tube in the trachea with a single insertion of a videolaryngoscope blade into the mouth and either a single insertion of an endotracheal tube into the mouth or a single insertion of a bougie into the mouth followed by a single insertion of an endotracheal tube over the bougie into the mouth.

次要结局

  • Number of intubation attempts(During intubation (minutes))
  • Need for additional airway equipment(Duration of procedure (minutes))
  • Difference in the overall success rate(During intubation (minutes))
  • Number of videolaryngoscopy attempts(Duration of procedure (minutes))
  • Modified Cormack-Lehane grade of glottic view(During intubation (minutes))
  • Diference in the incidence of "easy intubation"(During intubation (minutes))
  • Complications of tracheal intubation(Duration of procedure (minutes))
  • Duration of tracheal intubation(Duration of procedure (minutes))
  • Number of attempts to cannulate the trachea with a bougie or an endotracheal tube(Duration of procedure (minutes))
  • Need to change the device for intubation(Duration of procedure (minutes))
  • Reason for unsuccessful intubation on the first attempt(Duration of procedure (minutes))
  • Operator-assessed difficulty of intubation(Duration of procedure (minutes))

研究者

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

Manuel Taboada Muñiz

Professor Anesthesiology

Hospital Clinico Universitario de Santiago

研究点 (48)

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