Adverse Events in the Tracheal Intubation in the Intensive Care Unit

NCT03916224 | Completed

• 1 other identifier: 1149-N-18
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation; Difficult or Failed; Intubation Complication; Intubation

Keywords

Intubation; Airway management

Outcome Measures

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.

  28 days

Secondary Outcomes (5)

• Number of minor complications in the intubation process of patients admitted to Intensive Care Units.

  28 days

• Number of episodes in which pre-oxygenation methods are used

  28 days

• Frequency of videolaryngoscope use to perform intubation technique.

  28 days

• Association between videolaryngoscope use and incidence of 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

Study Arms (1)

Intubated critically ill patients

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Spanish Network for Research in Infectious Diseases: lead

Study Sites (1)

Jose Garnacho-Montero

Seville, 410018, Spain

Location

Study Officials

• Jose Garnacho-Montero, MD,Phd

  Virgen Macarena University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 16, 2019
• Study Start: April 15, 2019
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: April 2, 2021

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From now to the end of analysis
• Access Criteria: All participants

Locations

ES (1)