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

• ClinicalTrials.gov Identifier: NCT03916224
• Recruitment Status: Not yet recruiting
• First Posted: April 16, 2019
• Last Update Posted: April 16, 2019
• Sponsor: Spanish Network for Research in Infectious Diseases
• Information provided by (Responsible Party): José Garnacho Montero, Spanish Network for Research in Infectious Diseases

Tracking Information

• First Submitted Date: April 4, 2019
• First Posted Date: April 16, 2019
• Last Update Posted Date: April 16, 2019
• Estimated Study Start Date: April 15, 2019
• Estimated Primary Completion Date: June 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 12, 2019)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 12, 2019)

• 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.
• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 28 Days
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Critically ill patients, older than 18 years old, that are intubated at the participating Units.

Condition

• Intubation; Difficult or Failed
• Intubation Complication
• Intubation

• Intervention: Not Provided

Study Groups/Cohorts

Intubated critically ill patients

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: April 12, 2019): 1000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 30, 2020
• Estimated Primary Completion Date: June 30, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03916224
• Other Study ID Numbers: 1149-N-18
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Scheduled teleconferences
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: From now to the end of analysis
• Access Criteria: All participants

• Responsible Party: José Garnacho Montero, Spanish Network for Research in Infectious Diseases
• Study Sponsor: Spanish Network for Research in Infectious Diseases
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jose Garnacho-Montero, MD,Phd; Virgen Macarena University Hospital

• PRS Account: Spanish Network for Research in Infectious Diseases
• Verification Date: April 2019