Delirium in the Intensive Care UnitNCT07196813
The Association Between the Extubation Process and Delirium in the Intensive Care Unit
An observational study of Delirium in the Intensive Care Unit and Mechanical Ventilation Complication, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium in the Intensive Care Unit, Mechanical Ventilation Complication
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University Hospital
Eskişehir
About this study
Official title: 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.
- Keywords
- delirium, CAM*ICU, PaO2/FiO2
- Medical subject headings
- Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Patient assessments were conducted during the period immediately before extubation and within the 48-hour period following extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Jun 2022
- Primary completion2 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium in the Intensive Care UnitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ilker uğurlu, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196813
- Sponsor's protocol ID
- E-80558721-050.99-328825
- Status last verified
- Sep 2025
- First submitted
- 20 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Relationship Between Weaning Process And Delirium
- ClinicalTrials.gov ID
- NCT07196813
- Acronym / sponsor ID
- E-80558721-050.99-328825
- Keywords
- delirium, CAM*ICU, PaO2/FiO2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 2 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium in the Intensive Care Unit and Mechanical Ventilation Complication, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.