Adverse Events in the Tracheal Intubation in the Intensive Care Unit

NCT ID: NCT03916224

Last Updated: 2021-04-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2020-10-31

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.

Conditions

Intubation; Difficult or Failed; Intubation Complication; Intubation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Intubated critically ill patients

Critically ill patients older than 18 years old, intubated in an Intensive Care Unit.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spanish Network for Research in Infectious Diseases

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose Garnacho-Montero, MD,Phd

Role: PRINCIPAL_INVESTIGATOR

Virgen Macarena University Hospital

Locations

Jose Garnacho-Montero

Seville, , Spain

Countries

Spain

Other Identifiers

1149-N-18

Identifier Type: -

Identifier Source: org_study_id