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Clinical Trials/NCT03916224
NCT03916224
Completed
Not Applicable

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 site in 1 country1,800 target enrollmentApril 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intubation; Difficult or Failed
Sponsor
Spanish Network for Research in Infectious Diseases
Enrollment
1800
Locations
1
Primary Endpoint
Occurrence of major complications in the intubation process of patients admitted to Intensive Care Units.
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 15, 2019
End Date
October 31, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Spanish Network for Research in Infectious Diseases
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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