Adverse Events in the Tracheal Intubation in the Intensive Care Unit

Intubation Clinical Trial

— INTUPROS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03916224
• Other study ID #: 1149-N-18
• Status: Completed
• Start date: April 15, 2019
• Est. completion date: October 31, 2020

Study information

• Verified date: April 2019
• Source: Spanish Network for Research in Infectious Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intubation
• Intubation Complication
• Intubation; Difficult or Failed

Locations

Country	Name	City	State
Spain	Jose Garnacho-Montero	Seville

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Network for Research in Infectious Diseases

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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