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临床试验/NCT03916224
NCT03916224已完成不适用

Clinical Practice and Risk Factors for Major Adverse Events in the Tracheal Intubation in the Intensive Care Unit: A Prospective Multicentre Study

Spanish Network for Research in Infectious Diseases1 个研究点 分布在 1 个国家目标入组 1,800 人开始时间: 2019年4月15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
1,800
试验地点
1
主要终点
Occurrence of major complications in the intubation process of patients admitted to Intensive Care Units.

研究概览

简要总结

The airway management is essential in the Critical Care setting, both normal and difficult airway patients. Intubation is a risk procedure in which a great number of complications may occur, including death. The poor physiological reserve of critical patients may suppose an additional handicap to carry out successfully intubation.

The purpose of this study is to analyze the prevalence and risk factors for major complications in the intubation process in the Intensive Care Unit (ICU). In addition, the investigators will assess the impact of preoxygenation and the use of videolaryngoscope on the occurrence of major and minor complications. Finally, this study will review the drug protocols used in each participant ICU during intubation process.

详细描述

The correct airway and difficult airway management are essential in the Critical Care setting.

Intubation is a procedure frequently carried out by intensivist and a great number of complications have been related. Serious complications can occur, including the development of severe hypoxemia, arrhythmias, cardiac arrest with permanent anoxic brain damage or death. Additionally the poor physiological reserve of critically ill patients and the variable operator experience, means that this technique must be considered a risk event in critical patients.

In recent years, it has been taken more and more importance of preoxygenation as a strategy that can avoid major complications in the intubation process.

Similarly, the use of devices that facilitate intubation such as videolaryngoscopy, has been included in difficult airway management protocols. If the use of videolaryngoscopy compared with traditional laryngoscopy is associated with a higher success rate and a lower incidence of complications, still remains controversial.

The investigators want to know the prevalence and risk factors for major complications in the intubation process of patients admitted to Intensive Care Unit (ICU). In addition, this study will try to assess the use and impact of both preoxygenation and videolaryngoscope in the intubation process.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patients that are intubated at the participating Intensive Care Units.

排除标准

  • Intubations carried out at other different areas.
  • Patients under 18 years of age.

结局指标

主要结局

Occurrence of major complications in the intubation process of patients admitted to Intensive Care Units.

时间窗: 28 days

This study will analyze the prevalence of major complications related to intubation technique in the participant critical care units. This information will be useful in order to determinate the risk factors associated.

次要结局

  • Number of minor complications in the intubation process of patients admitted to Intensive Care Units.(28 days)
  • Occurrence of major complications in the intubation process of patients admitted to Intensive Care Units comparing COVID and non-COVID patients 28 days(28 days)
  • Number of episodes in which pre-oxygenation methods are used(28 days)
  • Frequency of videolaryngoscope use to perform intubation technique.(28 days)
  • Association between videolaryngoscope use and incidence of complications compared with conventional laryngoscopy.(28 days)

研究者

发起方
Spanish Network for Research in Infectious Diseases
申办方类型
Other
责任方
Sponsor

研究点 (1)

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