The Association Between the Extubation Process and Delirium in the Intensive Care Unit

NCT07196813 | Completed

• 1 other identifier: E-80558721-050.99-328825
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

There are limited studies in the literature investigating the relationship between delirium and the pre- and post-extubation periods in patients planned for extubation. Determining the impact of existing delirium during the extubation process or the possible causes of delirium occurring in this period may contribute to early recognition, prevention, or treatment of delirium. In our study, we screened patients scheduled for extubation in the intensive care unit using the Confusion Assessment Method for the ICU (CAM-ICU) before extubation and during the 48-hour post-extubation period to investigate the type of delirium, its relationship with sedation, and possible triggering and risk factors. Methods: The study was conducted with 38 patients over 18 years old who had been on mechanical ventilation (MV) for at least 24 hours and had Richmond Agitation and Sedation Scale (RASS) scores between +4 and -3. CAM-ICU was applied to patients before extubation, and then the patients were weaned from mechanical ventilation. Age, sex, APACHE-II, SOFA, mCCI scores, length of stay, and duration of intubation were compared between CAM-ICU negative and positive patients before extubation, and the relationship with sedation type was evaluated. CAM-ICU was also applied at 24 and 48 hours after extubation, and the results were compared with arterial blood gas parameters including PaO2/FiO2, PCO2, and lactate levels.

Conditions

Delirium in the Intensive Care Unit; Mechanical Ventilation Complication

Keywords

delirium, CAM*ICU, PaO2/FiO2

Outcome Measures

Primary Outcomes (1)

• The association between delirium and the 24-hour period before extubation and the 48-hour period after extubation in 38 patients for whom extubation was indicated.

  The study was carried out in patients who were followed under MV and in whom a decision for extubation was made by the attending physician. The sample size was determined as 38 patients. Delirium screening was performed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) during the period immediately before extubation and within the 48-hour period after extubation. In sedated patients, the sedative agent was recorded, and sedation was gradually reduced and discontinued 4-6 hours before each assessment. Immediately before extubation, the RASS was applied to assess the level of sedation and agitation. Patients with RASS scores between +4 and -3 were assessed using the CAM-ICU. At 24 and 48 hours after extubation, RASS was applied first, followed by CAM-ICU. Patients with a positive CAM-ICU result were considered to have delirium. The delirium subtype was determined according to the RASS score

  Patient assessments were conducted during the period immediately before extubation and within the 48-hour period following extubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study was carried out in patients who were followed under MV and in whom a decision for extubation was made by the attending physician. The sample size was determined as 38 patients

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskisehir Osmangazi University Hospital

Eskişehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: September 20, 2025
• First Posted: September 29, 2025
• Study Start: June 1, 2022
• Primary Completion: August 2, 2023
• Study Completion: September 1, 2023
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

TU (1)