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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03916224
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
José Garnacho Montero, Spanish Network for Research in Infectious Diseases

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.


Condition or disease
Intubation; Difficult or Failed Intubation Complication Intubation

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 28 Days
Official Title: Clinical Practice and Risk Factors for Major Adverse Events in the Tracheal Intubation in the Intensive Care Unit: A Prospective Multicentre Study
Estimated Study Start Date : April 15, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : September 30, 2020

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



Primary Outcome Measures :
  1. Occurrence of major complications in the intubation process of patients admitted to Intensive Care Units. [ Time Frame: 28 days ]
    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.


Secondary Outcome Measures :
  1. Number of minor complications in the intubation process of patients admitted to Intensive Care Units. [ Time Frame: 28 days ]
    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.

  2. Number of episodes in which pre-oxygenation methods are used [ Time Frame: 28 days ]
    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.

  3. Frequency of videolaryngoscope use to perform intubation technique. [ Time Frame: 28 days ]

    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.


  4. Association between videolaryngoscope use and incidence of complications compared with conventional laryngoscopy. [ Time Frame: 28 days ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916224


Contacts
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Contact: Jose Garnacho-Montero, MD, PHD +3469753643 jgarnachom@gmail.com

Sponsors and Collaborators
Spanish Network for Research in Infectious Diseases
Investigators
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Principal Investigator: Jose Garnacho-Montero, MD,Phd Virgen Macarena University Hospital
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Responsible Party: José Garnacho Montero, Director of the Intensive Care Unit., Spanish Network for Research in Infectious Diseases
ClinicalTrials.gov Identifier: NCT03916224    
Other Study ID Numbers: 1149-N-18
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Scheduled teleconferences
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: From now to the end of analysis
Access Criteria: All participants

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by José Garnacho Montero, Spanish Network for Research in Infectious Diseases:
Intubation
Airway management