Clinical trial NCT03916224: Adverse Events in the Tracheal Intubation in the Intensive Care Unit
Official title: Clinical Practice and Risk Factors for Major Adverse Events in the Tracheal Intubation in the Intensive Care Unit: A Prospective Multicentre Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation; Difficult or Failed
Intubation Complication
Intubation
Keywords: Intubation
Airway management
Lead sponsor: Spanish Network for Research in Infectious Diseases
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients, older than 18 years old, that are intubated at the participating Units.

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.

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.

Primary outcomes:
measure: Occurrence of major complications in the intubation process of patients admitted to Intensive Care Units.
timeFrame: 28 days
Secondary outcomes:
measure: Number of minor complications in the intubation process of patients admitted to Intensive Care Units.
timeFrame: 28 days
measure: Number of episodes in which pre-oxygenation methods are used
timeFrame: 28 days
measure: Frequency of videolaryngoscope use to perform intubation technique.
timeFrame: 28 days
measure: Association between videolaryngoscope use and incidence of complications compared with conventional laryngoscopy.
timeFrame: 28 days
measure: Occurrence of major complications in the intubation process of patients admitted to Intensive Care Units comparing COVID and non-COVID patients 28 days
timeFrame: 28 days
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Jose Garnacho-Montero
Study officials:
affiliation: Virgen Macarena University Hospital
name: Jose Garnacho-Montero, MD,Phd
role: PRINCIPAL_INVESTIGATOR
References: