Adverse Events in the Tracheal Intubation in the Intensive Care Unit (INTUPROS)

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

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.

Study Overview

• Status: Completed
• Conditions: Intubation; Intubation Complication; Intubation; Difficult or Failed

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.

• Study Type: Observational
• Enrollment (Actual): 1800

Contacts and Locations

Study Locations

• Spain
  • Seville, Spain, 410018
    • Jose Garnacho-Montero

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients, older than 18 years old, that are intubated at the participating Units.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Intubated critically ill patients; Critically ill patients older than 18 years old, intubated in an Intensive Care Unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of major complications in the intubation process of patients admitted to Intensive Care Units.	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.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of minor complications in the intubation process of patients admitted to Intensive Care Units.	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.	28 days
Number of episodes in which pre-oxygenation methods are used	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.	28 days
Frequency of videolaryngoscope use to perform intubation technique.	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.	28 days
Association between videolaryngoscope use and incidence of complications compared with conventional laryngoscopy.	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.	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

Collaborators and Investigators

• Sponsor: Spanish Network for Research in Infectious Diseases
• Investigators: Principal Investigator: Jose Garnacho-Montero, MD,Phd, Virgen Macarena University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 2, 2021
• Last Update Submitted That Met QC Criteria: March 30, 2021
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Intubation; Airway management
• Other Study ID Numbers: 1149-N-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Scheduled teleconferences
• IPD Sharing Time Frame: From now to the end of analysis
• IPD Sharing Access Criteria: All participants
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No