Delirium - PostoperativeNCT07510711
Value of the Time-Weighted Average (TWA) of Mean Arterial Pressure (MAP) and Cerebral Oximetry (rSO₂) as Predictors of Postoperative Tissue Perfusion Impairment in Patients Undergoing Cardiac Surgery
An observational study of Delirium - Postoperative and Postoperative Cognitive Dysfunction (POCD), run by Hospital Universitari Vall d'Hebron Research Institute.
Trial summary
Neurological problems after heart surgery are common and include confusion, memory loss, and difficulty thinking clearly. These issues may appear hours or days after surgery and can negatively affect recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium - Postoperative, Postoperative Cognitive Dysfunction (POCD), Postoperative Acute Kidney Injury
- What is being tested?
- Continuous intraoperative monitoring of MAP and rSO₂; observational study with no therapeutic intervention.
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to Nov 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adult patients (≥18 years) undergoing cardiac surgery, with or without cardiopulmonary bypass. Patients must provide written informed consent, have a preoperative Glasgow Coma Scale score of 15, no history of dementia or cognitive impairment, and be oriented and cooperative prior to surgery. Continuous intraoperative monitoring of mean arterial pressure (MAP) and cerebral regional oxygen saturation (rSO₂) is performed. Emergency surgeries and patients with pre-existing cognitive impairment are excluded.
Who may be able to join
- Age >18 years
- Undergoing cardiac surgery, with or without cardiopulmonary bypass
- Written informed consent
- Preoperative cognitive status: Glasgow Coma Scale score of 15; no history of dementia; no evidence of cognitive impairment on baseline assessment; patient oriented and cooperative prior to surgery
- Continuous intraoperative monitoring of mean arterial pressure (MAP) and cerebral regional oxygen saturation (rSO₂)
Who cannot join
- History of dementia or cognitive impairment
- Emergency surgeries
About this study
Neurological problems after heart surgery are common and include confusion, memory loss, and difficulty thinking clearly. These issues may appear hours or days after surgery and can negatively affect recovery.
During heart surgery, blood flow and oxygen delivery to the brain may decrease, causing changes in blood pressure and cerebral oxygenation. Previous studies suggest that prolonged drops in mean arterial pressure (MAP) or cerebral oxygenation (rSO₂) are linked to worse postoperative outcomes. Continuous monitoring of blood pressure and cerebral oxygenation is standard in cardiac surgery.
Read more
This study aims to evaluate the duration and severity of intraoperative drops in MAP and cerebral oxygenation. These measures may provide a more accurate assessment of neurological risk than isolated measurements.
The primary objective is to determine whether decreases in MAP and cerebral oxygenation, as well as their duration and intensity during surgery, are associated with postoperative neurological complications.
This is a prospective, observational study in adult patients undergoing cardiac surgery, with or without cardiopulmonary bypass (CPB). CPB diverts blood through a machine that performs the work of the heart and lungs while the heart is operated on. All patients will receive standard monitoring, including continuous MAP and cerebral oxygenation measurements. No additional interventions will be performed.
Neurological status will be assessed using validated clinical scales before and after surgery. Other outcomes include kidney function, ICU and hospital stay length, postoperative complications, and in-hospital mortality.
Validating these measures as a predictive tool could enable early identification of patients at higher risk of neurological injury and allow more individualized intraoperative management to reduce morbidity, hospital stay, and healthcare costs.
Read the detailed description
Postoperative neurocognitive dysfunction (PND), which includes postoperative delirium (POD) and postoperative cognitive dysfunction (POCD), is a frequent complication in patients undergoing cardiac surgery, with reported incidences of 14-35% for POD and up to 80% for POCD. Both conditions have been associated with prolonged intensive care unit (ICU) and hospital stays, long-term cognitive decline, and increased mortality.
POD is defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), as an acute and fluctuating disturbance of attention and awareness, accompanied by cognitive or perceptual changes, typically occurring in the first days after surgery. The most commonly used assessment tool is the Confusion Assessment Method for the ICU (CAM-ICU), which demonstrates high sensitivity and specificity and is suitable for intubated patients or those in critical care.
POCD is considered a persistent reduction in cognitive function, particularly memory, attention, processing speed, and executive functions. It usually appears after the first postoperative week and can last from weeks to months, being more common in older adults. The Mini Mental State Exam (MMSE) is recommended as a screening and predictive tool for POCD.
There is evidence that significant decreases in cerebral oxygen saturation (rSO₂), measured non-invasively by near-infrared spectroscopy (NIRS) (either a drop >20% from baseline or absolute values <50%), are associated with higher rates of postoperative neurocognitive dysfunction. Prolonged intraoperative hypotension, defined as mean arterial pressure (MAP) <65 mmHg, is also linked to worse postoperative neurological outcomes.
Several studies have compared whether rSO₂ or MAP better detect postoperative neurocognitive dysfunction, with some showing that rSO₂ is a more sensitive predictor, reflecting global perfusion and immediate prognosis. Clinical practice guidelines recommend monitoring rSO₂ to improve neurological outcomes after cardiac surgery. Decreases in rSO₂ can indicate microcirculatory dysfunction even when blood pressure appears normal, correlating with adverse clinical outcomes such as elevated lactate, acute kidney injury, prolonged mechanical ventilation, or extended vasopressor use.
The time-weighted average (TWA) allows quantification not only of the magnitude but also the duration of hemodynamic or hypoxic deviations. TWA is calculated as:
TWA = ∑ (depth of deviation × duration in minutes) / total procedure duration
For TWA-MAP, the depth is the number of mmHg below 65 mmHg, multiplied by the duration, and adjusted to the total procedure time. The same principle applies to TWA-rSO₂. Elevated TWA-MAP indicates macrohemodynamic dysfunction, whereas elevated TWA-rSO₂ reflects cerebral microcirculatory dysfunction.
Previous studies have correlated TWA-MAP with acute kidney injury, ICU stay, and mortality. TWA-rSO₂ has been used in observational studies and correlated with lactate levels, creatinine, or duration of vasopressor therapy. However, no studies have evaluated the predictive value of TWA-MAP and TWA-rSO₂ for postoperative neurocognitive dysfunction (delirium or cognitive impairment) after cardiac surgery. Critical gaps remain in establishing validated TWA thresholds for predicting brain injury, determining whether neurological impairment develops beyond the intraoperative period, and evaluating the diagnostic sensitivity and specificity of this tool.
- Conditions
- Delirium - Postoperative, Postoperative Cognitive Dysfunction (POCD), Postoperative Acute Kidney Injury, Postoperative Morbidity, Intensity Care Unit Length of Stay
- Being tested
- Continuous intraoperative monitoring of MAP and rSO₂; observational study with no therapeutic intervention.
- Medical subject headings
- Emergence Delirium, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous intraoperative monitoring of MAP and rSO₂; observational study with no therapeutic intervention.Other
Participants will undergo continuous intraoperative monitoring of mean arterial pressure (MAP) and cerebral regional oxygen saturation (rSO₂). MAP will be measured invasively via an arterial catheter, and rSO₂ will be assessed non-invasively using near-infrared spectroscopy (NIRS). Monitoring will begin from induction of anesthesia until the end of surgery. No therapeutic interventions will be applied as part of the study; all anesthetic and surgical management will follow standard institutional protocols. The collected MAP and rSO₂ data will be used to calculate time-weighted averages (TWA), which will then be analyzed for associations with postoperative neurocognitive dysfunction (delirium or cognitive impairment) and other clinical outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients undergoing cardiac surgery | Adult patients (≥18 years) undergoing cardiac surgery, with or without cardiopulmonary bypass. Preoperative cognitive status: Glasgow Coma Scale score of 15, no history of dementia, no evidence of cognitive impairment on baseline assessment, patient oriented and cooperative prior to surgery. Intraoperative monitoring includes continuous mean arterial pressure (MAP) and cerebral regional oxygen saturation (rSO₂). Receives: Other: Continuous intraoperative monitoring of MAP and rSO₂; observational study with no therapeutic intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of TWA-MAP and TWA-rSO₂ with Postoperative Neurocognitive Dysfunction
Postoperative neurocognitive dysfunction (delirium or cognitive impairment) following cardiac surgery
Measured: From day of surgery until 3 months after surgery
Secondary outcomes (4)
Association of TWA-MAP and TWA-rSO₂ with Acute Kidney Injury
acute kidney injury
Measured: From day of surgery until 3 months after surgery
To determine whether TWA-MAP and TWA-rSO₂ are associated with longer intensive care unit (ICU) length of stay.
intensive care unit (ICU) length of stay
Measured: From day of surgery until 3 months after surgery
To determine whether TWA-MAP and TWA-rSO₂ are associated with hospital length of stay
hospital length of stay
Measured: From day of surgery until 3 months after surgery
To determine whether TWA-MAP and TWA-rSO₂ are associated with in-hospital mortality
in-hospital mortality
Measured: From day of surgery until 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium - PostoperativeStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510711
- Sponsor's protocol ID
- PR(AG)391/2025
- Status last verified
- Mar 2026
- First submitted
- 11 Feb 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of the Time-Weighted Average (TWA) of Mean Arterial Pressure (MAP) and Cerebral Oximetry (rSO₂) as Predictors of Postoperative Tissue Perfusion Impairment in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07510711
- Acronym / sponsor ID
- PR(AG)391/2025
- Conditions
- Delirium - Postoperative, Postoperative Cognitive Dysfunction (POCD), Postoperative Acute Kidney Injury, Postoperative Morbidity, Intensity Care Unit Length of Stay
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 3 Apr 2026 (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.
Neurological problems after heart surgery are common and include confusion, memory loss, and difficulty thinking clearly. These issues may appear hours or days after surgery and can negatively affect recovery.
During heart surgery, blood flow and oxygen delivery to the brain may decrease, causing changes in blood pressure and cerebral oxygenation. Previous studies suggest that prolonged drops in mean arterial pressure (MAP) or cerebral oxygenation (rSO₂) are linked to worse postoperative outcomes. Continuous monitoring of blood pressure and cerebral oxygenation is standard in cardiac surgery.
This study aims to evaluate the duration and severity of intraoperative drops in MAP and cerebral oxygenation. These measures may provide a more accurate assessment of neurological risk than isolated measurements.
The primary objective is to determine whether decreases in MAP and cerebral oxygenation, as well as their duration and intensity during surgery, are associated with postoperative neurological complications.
This is a prospective, observational study in adult patients undergoing cardiac surgery, with or without cardiopulmonary bypass (CPB). CPB diverts blood through a machine that performs the work of the heart and lungs while the heart is operated on. All patients will receive standard monitoring, including continuous MAP and cerebral oxygenation measurements. No additional interventions will be performed.
Neurological status will be assessed using validated clinical scales before and after surgery. Other outcomes include kidney function, ICU and hospital stay length, postoperative complications, and in-hospital mortality.
Validating these measures as a predictive tool could enable early identification of patients at higher risk of neurological injury and allow more individualized intraoperative management to reduce morbidity, hospital stay, and healthcare costs.
Detailed description
Postoperative neurocognitive dysfunction (PND), which includes postoperative delirium (POD) and postoperative cognitive dysfunction (POCD), is a frequent complication in patients undergoing cardiac surgery, with reported incidences of 14-35% for POD and up to 80% for POCD. Both conditions have been associated with prolonged intensive care unit (ICU) and hospital stays, long-term cognitive decline, and increased mortality.
POD is defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), as an acute and fluctuating disturbance of attention and awareness, accompanied by cognitive or perceptual changes, typically occurring in the first days after surgery. The most commonly used assessment tool is the Confusion Assessment Method for the ICU (CAM-ICU), which demonstrates high sensitivity and specificity and is suitable for intubated patients or those in critical care.
POCD is considered a persistent reduction in cognitive function, particularly memory, attention, processing speed, and executive functions. It usually appears after the first postoperative week and can last from weeks to months, being more common in older adults. The Mini Mental State Exam (MMSE) is recommended as a screening and predictive tool for POCD.
There is evidence that significant decreases in cerebral oxygen saturation (rSO₂), measured non-invasively by near-infrared spectroscopy (NIRS) (either a drop >20% from baseline or absolute values <50%), are associated with higher rates of postoperative neurocognitive dysfunction. Prolonged intraoperative hypotension, defined as mean arterial pressure (MAP) <65 mmHg, is also linked to worse postoperative neurological outcomes.
Several studies have compared whether rSO₂ or MAP better detect postoperative neurocognitive dysfunction, with some showing that rSO₂ is a more sensitive predictor, reflecting global perfusion and immediate prognosis. Clinical practice guidelines recommend monitoring rSO₂ to improve neurological outcomes after cardiac surgery. Decreases in rSO₂ can indicate microcirculatory dysfunction even when blood pressure appears normal, correlating with adverse clinical outcomes such as elevated lactate, acute kidney injury, prolonged mechanical ventilation, or extended vasopressor use.
The time-weighted average (TWA) allows quantification not only of the magnitude but also the duration of hemodynamic or hypoxic deviations. TWA is calculated as:
TWA = ∑ (depth of deviation × duration in minutes) / total procedure duration
For TWA-MAP, the depth is the number of mmHg below 65 mmHg, multiplied by the duration, and adjusted to the total procedure time. The same principle applies to TWA-rSO₂. Elevated TWA-MAP indicates macrohemodynamic dysfunction, whereas elevated TWA-rSO₂ reflects cerebral microcirculatory dysfunction.
Previous studies have correlated TWA-MAP with acute kidney injury, ICU stay, and mortality. TWA-rSO₂ has been used in observational studies and correlated with lactate levels, creatinine, or duration of vasopressor therapy. However, no studies have evaluated the predictive value of TWA-MAP and TWA-rSO₂ for postoperative neurocognitive dysfunction (delirium or cognitive impairment) after cardiac surgery. Critical gaps remain in establishing validated TWA thresholds for predicting brain injury, determining whether neurological impairment develops beyond the intraoperative period, and evaluating the diagnostic sensitivity and specificity of this tool.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients undergoing cardiac surgery | – | Other: Continuous intraoperative monitoring of MAP and rSO₂; observational study with no therapeutic intervention.Adult patients (≥18 years) undergoing cardiac surgery, with or without cardiopulmonary bypass. Preoperative cognitive status: Glasgow Coma Scale score of 15, no history of dementia, no evidence of cognitive impairment on baseline assessment, patient oriented and cooperative prior to surgery. Intraoperative monitoring includes continuous mean arterial pressure (MAP) and cerebral regional oxygen saturation (rSO₂). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) undergoing cardiac surgery, with or without cardiopulmonary bypass. Patients must provide written informed consent, have a preoperative Glasgow Coma Scale score of 15, no history of dementia or cognitive impairment, and be oriented and cooperative prior to surgery. Continuous intraoperative monitoring of mean arterial pressure (MAP) and cerebral regional oxygen saturation (rSO₂) is performed. Emergency surgeries and patients with pre-existing cognitive impairment are excluded.
Key inclusion criteria (5 listed)
- Age >18 years
- Undergoing cardiac surgery, with or without cardiopulmonary bypass
- Written informed consent
- Preoperative cognitive status: Glasgow Coma Scale score of 15; no history of dementia; no evidence of cognitive impairment on baseline assessment; patient oriented and cooperative prior to surgery
- Continuous intraoperative monitoring of mean arterial pressure (MAP) and cerebral regional oxygen saturation (rSO₂)
Key exclusion criteria (2 listed)
- History of dementia or cognitive impairment
- Emergency surgeries
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 |
|---|---|---|
| Continuous intraoperative monitoring of MAP and rSO₂; observational study with no therapeutic intervention.Participants will undergo continuous intraoperative monitoring of mean arterial pressure (MAP) and cerebral regional oxygen saturation (rSO₂). MAP will be measured invasively via an arterial catheter, and rSO₂ will be assessed non-invasively using near-infrared spectroscopy (NIRS). Monitoring will begin from induction of anesthesia until the end of surgery. No therapeutic interventions will be applied as part of the study; all anesthetic and surgical management will follow standard institutional protocols. The collected MAP and rSO₂ data will be used to calculate time-weighted averages (TWA), which will then be analyzed for associations with postoperative neurocognitive dysfunction (delirium or cognitive impairment) and other clinical outcomes. | Other | Adult patients undergoing cardiac surgery |
Primary outcome
Association of TWA-MAP and TWA-rSO₂ with Postoperative Neurocognitive Dysfunction
Time frame: From day of surgery until 3 months after surgery
Postoperative neurocognitive dysfunction (delirium or cognitive impairment) following cardiac surgery
4 secondary outcomes
Association of TWA-MAP and TWA-rSO₂ with Acute Kidney Injury
Time frame: From day of surgery until 3 months after surgery
To determine whether TWA-MAP and TWA-rSO₂ are associated with longer intensive care unit (ICU) length of stay.
Time frame: From day of surgery until 3 months after surgery
To determine whether TWA-MAP and TWA-rSO₂ are associated with hospital length of stay
Time frame: From day of surgery until 3 months after surgery
To determine whether TWA-MAP and TWA-rSO₂ are associated with in-hospital mortality
Time frame: From day of surgery until 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium - Postoperative and Postoperative Cognitive Dysfunction (POCD), run by Hospital Universitari Vall d'Hebron Research Institute.
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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Association of TWA-MAP and TWA-rSO₂ with Postoperative Neurocognitive Dysfunction (time frame: From day of surgery until 3 months after surgery). 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 3 Apr 2026.