Postoperative Delirium (POD)CLEVERNCT06752421
Effect of Low Tidal Volume Ventilation on Postoperative Delirium
A study testing Group B: Low tidal volume in people with Postoperative Delirium (POD) and Cardiopulmonary Bypass, run by Nevsehir Public Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effect of low tidal volume (LTV) ventilation during cardiopulmonary bypass (CPB) on postoperative delirium. It is hypothesized that the risk of delirium, which negatively impacts recovery following cardiac surgeries, can be reduced by improving cerebral perfusion and oxygenation through… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Delirium (POD), Cardiopulmonary Bypass, Low Tidal Volume Ventilation
- What is being tested?
- Group B: Low tidal volume
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 28 Feb 2026
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All male or female patients over the age of 18
- Patients undergoing planned cardiac surgeries including CABG
- Patients with an American Society of Anesthesiologists (ASA) physical status of II, III, or IV
Who cannot join
- Emergency surgeries will be excluded due to the high likelihood of non-compliance with the protocol and the potential lack of essential patient information.
- Surgeries requiring single-lung ventilation will be excluded as they may cause confusion in determining any effects of the intervention due to the inability to apply the study intervention and the differential treatment of the lungs.
- Patients who meet delirium criteria according to 3D-CAM measurements during the initial visit will be excluded.
- Patients with a life expectancy of less than 6 months or a history of psychiatric or neurological diseases (including depression, severe central nervous system depression, schizophrenia, epilepsy, Parkinson's disease, and Alzheimer's disease) will be excluded.
- Severe impairments such as blindness, severe deafness, or dementia that may hinder cognitive testing will be excluded.
- Patients using psychotropic or opioid medications, those with a history of delirium, or those with a history of alcohol abuse or withdrawal within the past 6 months will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Continuous Low Tidal Volume Ventilation During Cardiopulmonary Bypass on Postoperative Delirium: A Prospective Randomized Controlled Trial
This study aims to evaluate the effect of low tidal volume (LTV) ventilation during cardiopulmonary bypass (CPB) on postoperative delirium. It is hypothesized that the risk of delirium, which negatively impacts recovery following cardiac surgeries, can be reduced by improving cerebral perfusion and oxygenation through LTV. The study is designed as a prospective, randomized, controlled trial comparing delirium incidence, ICU stay duration, and 30-day mortality/morbidity rates between LTV and apnea groups. Primary outcomes will be assessed using the 3D-CAM method, while secondary outcomes include ICU stay duration and mortality/morbidity rates.
Read the detailed description
Introduction and Objectives:
This protocol aims to evaluate the effect of low tidal volume (LTV) ventilation during cardiopulmonary bypass (CPB) on postoperative delirium. Postoperative delirium, commonly seen after cardiac surgeries, negatively impacts patient recovery. It is hypothesized that LTV reduces the risk of delirium by improving cerebral perfusion and oxygenation. The study objectives include comparing the incidence of delirium, ICU stay duration, and 30-day mortality/morbidity rates between groups.
Study Design and Methods:
This prospective, randomized, controlled trial will involve two groups: patients receiving LTV ventilation and those undergoing apnea during CPB. Inclusion criteria target CABG patients over 18 years of age, while exclusion criteria include emergent surgeries and cognitive impairments. Randomization will ensure balanced group allocation through computer-based methods. Mechanical ventilation parameters will follow standard protocols for both groups.
Measurements and Hypotheses:
The primary outcome is delirium, assessed using the 3D-CAM method, while secondary outcomes include ICU stay duration and 30-day composite mortality/morbidity rates. LTV ventilation is expected to reduce delirium incidence, shorten ICU stay, and lower mortality/morbidity rates. Statistical analyses will include multivariable models to account for potential confounding factors.
Substudies and Limitations:
The protocol includes two substudies to evaluate microcirculation and renal perfusion. Limitations may arise from the overlap of sedation effects with delirium symptoms, variations in surgical techniques, and potential data loss during patient follow-ups. Interim analyses are planned to assess the study's safety and effectiveness. The study will be conducted without external funding, adhering to routine clinical practices.
- Conditions
- Postoperative Delirium (POD), Cardiopulmonary Bypass, Low Tidal Volume Ventilation, Cognitive Dysfunction, Postoperative
- Being tested
- Group B: Low tidal volume
- Keywords
- Postoperative Delirium, Cardiopulmonary Bypass, low tidal volume ventilation, Cognitive Dysfunction
- Medical subject headings
- Emergence Delirium, Postoperative Cognitive Complications, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group B: Low tidal volumeProcedure or surgery
In the LTV group, mechanical ventilation will be maintained with low tidal volume parameters after the aortic cross-clamp procedure. This intervention includes a tidal volume of 3-4 mL/kg, respiratory rate of 12-14 breaths/min, PEEP of 5-8 cmH₂O, and FiO₂ of 50%. Minute ventilation (MV) will not exceed 12 L, and the parameters are adjusted according to ideal body weight. This group is designed to evaluate the protective effects of low tidal volume ventilation during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Apnea | No intervention | The apnea group serves as the control group. In routine Coronary Artery Bypass Grafting (CABG) surgery, after the cross clamp procedure, the mechanical ventilator is turned off, and the process is maintained by cardiopulmonary bypass (CPB). In this group, no mechanical ventilation will be provided after the cross clamp procedure, and apnea will be applied as part of routine care. The process will be entirely maintained by CPB. |
| Group B: Low Tidal Volume (LTV) | Experimental | In the LTV group, mechanical ventilation will be maintained with low tidal volume parameters after the aortic cross-clamp procedure. This intervention includes a tidal volume of 3-4 mL/kg, respiratory rate of 12-14 breaths/min, PEEP of 5-8 cmH₂O, and FiO₂ of 50%. Minute ventilation (MV) will not exceed 12 L, and the parameters are adjusted according to ideal body weight. This group is designed to evaluate the protective effects of low tidal volume ventilation during surgery. Receives: Procedure: Group B: Low tidal volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium incidence
The main objective of the study is to compare the rates of postoperative delirium between patients who received low tidal volume (LTV) ventilation and those who were apnea-induced during CABG surgeries. This will be measured by the incidence of delirium, and it will be statistically analyzed to determine whether there is a significant difference between the two groups.
Measured: From the point where the RASS score evaluating wakefulness is -3, for a duration of 48 hours
Secondary outcomes (3)
Length of stay in the intensive care unit (ICU)
The duration of postoperative ICU stay will be measured and compared between the groups.
Measured: The duration will be recorded in hours, starting from the time of ICU admission to the time of discharge.
30-day mortality rate
Mortality (death from any cause) rate occurring within the first 30 days post-surgery will be compared between the two groups .
Measured: In the first 30 days after surgery
30-day morbidity rate
morbidity (complications such as infections, cardiac events, respiratory failure, renal dysfunction, etc.) rate occurring within the first 30 days post-surgery will be compared between the two groups .
Measured: In the first 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start1 Jan 2025
- Primary completion8 Dec 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Delirium (POD)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- During cardiopulmonary bypass (CPB), apnea is routinely performed. In the control group, apnea ventilation will be continued, while in the intervention group, low tidal volume (LTV) ventilation will be applied.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nevsehir Public Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Akif Yazar, MD, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752421
- Sponsor's protocol ID
- TABED-24-851
- Acronym
- CLEVER
- Status last verified
- Mar 2026
- First submitted
- 21 Dec 2024
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuous Low Tidal Volume Ventilation During Cardiopulmonary Bypass on Postoperative Delirium: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06752421
- Acronym / sponsor ID
- CLEVER / TABED-24-851
- Conditions
- Postoperative Delirium (POD), Cardiopulmonary Bypass, Low Tidal Volume Ventilation, Cognitive Dysfunction, Postoperative
- Keywords
- Postoperative Delirium, Cardiopulmonary Bypass, low tidal volume ventilation, Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Nevsehir Public HospitalOther government
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 30 Dec 2024 (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.
This study aims to evaluate the effect of low tidal volume (LTV) ventilation during cardiopulmonary bypass (CPB) on postoperative delirium. It is hypothesized that the risk of delirium, which negatively impacts recovery following cardiac surgeries, can be reduced by improving cerebral perfusion and oxygenation through LTV. The study is designed as a prospective, randomized, controlled trial comparing delirium incidence, ICU stay duration, and 30-day mortality/morbidity rates between LTV and apnea groups. Primary outcomes will be assessed using the 3D-CAM method, while secondary outcomes include ICU stay duration and mortality/morbidity rates.
Detailed description
Introduction and Objectives:
This protocol aims to evaluate the effect of low tidal volume (LTV) ventilation during cardiopulmonary bypass (CPB) on postoperative delirium. Postoperative delirium, commonly seen after cardiac surgeries, negatively impacts patient recovery. It is hypothesized that LTV reduces the risk of delirium by improving cerebral perfusion and oxygenation. The study objectives include comparing the incidence of delirium, ICU stay duration, and 30-day mortality/morbidity rates between groups.
Study Design and Methods:
This prospective, randomized, controlled trial will involve two groups: patients receiving LTV ventilation and those undergoing apnea during CPB. Inclusion criteria target CABG patients over 18 years of age, while exclusion criteria include emergent surgeries and cognitive impairments. Randomization will ensure balanced group allocation through computer-based methods. Mechanical ventilation parameters will follow standard protocols for both groups.
Measurements and Hypotheses:
The primary outcome is delirium, assessed using the 3D-CAM method, while secondary outcomes include ICU stay duration and 30-day composite mortality/morbidity rates. LTV ventilation is expected to reduce delirium incidence, shorten ICU stay, and lower mortality/morbidity rates. Statistical analyses will include multivariable models to account for potential confounding factors.
Substudies and Limitations:
The protocol includes two substudies to evaluate microcirculation and renal perfusion. Limitations may arise from the overlap of sedation effects with delirium symptoms, variations in surgical techniques, and potential data loss during patient follow-ups. Interim analyses are planned to assess the study's safety and effectiveness. The study will be conducted without external funding, adhering to routine clinical practices.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- During cardiopulmonary bypass (CPB), apnea is routinely performed. In the control group, apnea ventilation will be continued, while in the intervention group, low tidal volume (LTV) ventilation will be applied.
| Arm | Type | Receives |
|---|---|---|
| Group A: Apnea | No intervention | –The apnea group serves as the control group. In routine Coronary Artery Bypass Grafting (CABG) surgery, after the cross clamp procedure, the mechanical ventilator is turned off, and the process is maintained by cardiopulmonary bypass (CPB). In this group, no mechanical ventilation will be provided after the cross clamp procedure, and apnea will be applied as part of routine care. The process will be entirely maintained by CPB. |
| Group B: Low Tidal Volume (LTV) | Experimental | Procedure: Group B: Low tidal volumeIn the LTV group, mechanical ventilation will be maintained with low tidal volume parameters after the aortic cross-clamp procedure. This intervention includes a tidal volume of 3-4 mL/kg, respiratory rate of 12-14 breaths/min, PEEP of 5-8 cmH₂O, and FiO₂ of 50%. Minute ventilation (MV) will not exceed 12 L, and the parameters are adjusted according to ideal body weight. This group is designed to evaluate the protective effects of low tidal volume ventilation during surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All male or female patients over the age of 18
- Patients undergoing planned cardiac surgeries including CABG
- Patients with an American Society of Anesthesiologists (ASA) physical status of II, III, or IV
Key exclusion criteria (6 listed)
- Emergency surgeries will be excluded due to the high likelihood of non-compliance with the protocol and the potential lack of essential patient information.
- Surgeries requiring single-lung ventilation will be excluded as they may cause confusion in determining any effects of the intervention due to the inability to apply the study intervention and the differential treatment of the lungs.
- Patients who meet delirium criteria according to 3D-CAM measurements during the initial visit will be excluded.
- Patients with a life expectancy of less than 6 months or a history of psychiatric or neurological diseases (including depression, severe central nervous system depression, schizophrenia, epilepsy, Parkinson's disease, and Alzheimer's disease) will be excluded.
- Severe impairments such as blindness, severe deafness, or dementia that may hinder cognitive testing will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group B: Low tidal volumeIn the LTV group, mechanical ventilation will be maintained with low tidal volume parameters after the aortic cross-clamp procedure. This intervention includes a tidal volume of 3-4 mL/kg, respiratory rate of 12-14 breaths/min, PEEP of 5-8 cmH₂O, and FiO₂ of 50%. Minute ventilation (MV) will not exceed 12 L, and the parameters are adjusted according to ideal body weight. This group is designed to evaluate the protective effects of low tidal volume ventilation during surgery. | Procedure or surgery | Group B: Low Tidal Volume (LTV) |
Primary outcome
Postoperative delirium incidence
Time frame: From the point where the RASS score evaluating wakefulness is -3, for a duration of 48 hours
The main objective of the study is to compare the rates of postoperative delirium between patients who received low tidal volume (LTV) ventilation and those who were apnea-induced during CABG surgeries. This will be measured by the incidence of delirium, and it will be statistically analyzed to determine whether there is a significant difference between the two groups.
3 secondary outcomes
Length of stay in the intensive care unit (ICU)
Time frame: The duration will be recorded in hours, starting from the time of ICU admission to the time of discharge.
30-day mortality rate
Time frame: In the first 30 days after surgery
30-day morbidity rate
Time frame: In the first 30 days after surgery
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 31 Mar 2026.
- Individual participant dataSharing planned: No
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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?
A study testing Group B: Low tidal volume in people with Postoperative Delirium (POD) and Cardiopulmonary Bypass, run by Nevsehir Public Hospital 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 3 inclusion and 6 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 31 Mar 2026. 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?
Postoperative delirium incidence (time frame: From the point where the RASS score evaluating wakefulness is -3, for a duration of 48 hours). 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 31 Mar 2026.