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

September 20, 2025 updated by: ilker uğurlu, Eskisehir Osmangazi University

Evaluation Of The Relationship Between Weaning Process And Delirium

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Eskişehir, Turkey (Türkiye)
        • Eskişehir Osmangazi University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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

Description

Inclusion Criteria:

  • Inclusion criteria were patients aged over 18 years, followed under MV for at least 24 hours, with a Richmond Agitation and Sedation Scale (RASS) score between +4 and -3, and for whom an extubation decision had been made

Exclusion Criteria:

  • Exclusion criteria were patients with RASS scores of -4 or -5, patients with a history of neurocognitive disorders (dementia, Alzheimer's disease), and patients whose relatives did not provide consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Patient assessments were conducted during the period immediately before extubation and within the 48-hour period following extubation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eskisehir Osmangazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 2, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-80558721-050.99-328825

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mechanical Ventilation Complication

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings