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CompletedNCT03916224INTUPROSUpdated Apr 2, 2021

Adverse Events in the Tracheal Intubation in the Intensive Care Unit

An observational study in Intubation; Difficult or Failed, Intubation Complication and Intubation, sponsored by Spanish Network for Research in Infectious Diseases. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-02.

Sponsored by Spanish Network for Research in Infectious Diseases · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,800
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Intubation; Difficult or Failed
  • Intubation Complication
  • Intubation

Keywords

  • Intubation
  • Airway management
03

In context

Lead sponsor

Spanish Network for Research in Infectious Diseases is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • Patients that are intubated at the participating Intensive Care Units.

Exclusion criteria

Exclusion Criteria:

  • Intubations carried out at other different areas.
  • Patients under 18 years of age.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,800 participants (actual)
Target follow-up
28 Days
Patient registry
Yes

Groups and cohorts

  • Intubated critically ill patients

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 28 days

Secondary outcomes

  1. 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.

    Time frame: 28 days

  2. 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.

    Time frame: 28 days

  3. 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.

    Time frame: 28 days

  4. 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.

    Time frame: 28 days

  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

07

Study locations

1 site
  • Jose Garnacho-Montero
    Seville, 410018, Spain
08

References and documents

Individual participant data

Plan to share: Yes — Scheduled teleconferences

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03916224
Lead sponsor
Spanish Network for Research in Infectious Diseases
Responsible party
Sponsor
First posted
Apr 16, 2019
Start date
Apr 15, 2019
Primary completion
Oct 31, 2020
Completion
Oct 31, 2020
Last update
Apr 2, 2021

Study contacts

Jose Garnacho-Montero, MD,Phd
principal investigator · Virgen Macarena University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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