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Completed

NCT Number: NCT03916224

Adverse Events in the Tracheal Intubation in the Intensive Care Unit

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.

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Key information

Conditions

Intubation; Difficult or Failed Intubation Intubation Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jose Garnacho-Montero

Seville, 410018, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Number of minor complications in the intubation process of patients admitted to Intensive Care Units.

    Time frame: 28 days

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

  2. Number of episodes in which pre-oxygenation methods are used

    Time frame: 28 days

    Pre-oxygenation is considered a strategy that can avoid complications in the intubation process. The investigators will define the frequency of use in each participant unit and its association with the development of major and minor complications. The study will describe the different pre-oxygenation options: conventional ambu mask, non invasive ventilation, high flow oxygenation.

  3. Frequency of videolaryngoscope use to perform intubation technique.

    Time frame: 28 days

    Nowadays the videolaryngoscopy is an useful tool included in difficult airway management protocols. Despite of this, the benefit associated to the videolaryngoscopy employment compared with traditional laryngoscopy is controversial.

    The investigators will analyze its role in the intubation protocols and the factors that determine its use. The difficult airway predictors scales used in the participant units are: Cormack-Lehane, MACOCHA.

  4. Association between videolaryngoscope use and incidence of complications compared with conventional laryngoscopy.

    Time frame: 28 days

    Nowadays, the videolaryngoscopy is an useful tool included in difficult airway management protocols. Despite of this, the benefit associated to the videolaryngoscopy employment compared with traditional laryngoscopy is controversial.

    The investigator will analyze (adjusting for confounding variables) if the use of videolaryngoscope is associated with a lower incidence of major and minor complications compared with conventional laryngoscopy.

  5. Occurrence of major complications in the intubation process of patients admitted to Intensive Care Units comparing COVID and non-COVID patients 28 days

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Spanish Network for Research in Infectious Diseases

Other

Registry information

Official study title

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

Acronym: INTUPROS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 16, 2019
Registry last updated
Apr 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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