Delirium - PostoperativeAUTO-PODNCT07671404
Cerebral Autoregulation and Delirium Study
A study testing Mespere NeuroOs (Mespere Life Sciences) monitor in people with Delirium - Postoperative and Cardiac Surgery, run by University Health Network, Toronto.
Trial summary
Approximately one in four elderly patients develops postoperative delirium (POD) after cardiac surgery. POD is associated with prolonged hospitalization, increased mortality, and higher health care costs. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Delirium - Postoperative, Cardiac Surgery
- What is being tested?
- Mespere NeuroOs (Mespere Life Sciences) monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 30 Jun 2028
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting patients aged ≥ 60 years undergoing elective complex cardiac surgery (coronary artery bypass grafting plus valve surgery, double-valve surgery, triple-valve surgery, redo operations, or aortic arch surgery), or patients aged ≥ 70 years undergoing isolated coronary artery bypass grafting or single-valve repair/replacement surgery.
Who cannot join
- Patients with symptomatic cerebrovascular disease.
- History of delirium.
- Major neurocognitive impairment (e.g., dementia or Mini-Mental State Examination score < 10).
- Schizophrenia.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Reducing Delirium After Cardiac Surgery: Personalized Targeted Blood Pressure Management Strategy Using Cerebral Autoregulation Monitoring: A Pilot Study
Approximately one in four elderly patients develops postoperative delirium (POD) after cardiac surgery. POD is associated with prolonged hospitalization, increased mortality, and higher health care costs. While patient-related risk factors are often difficult to modify, surgery- and anesthesia-related factors may be optimized to reduce the incidence of POD. One potentially modifiable factor is intraoperative blood pressure management. Current practice commonly relies on standardized blood pressure targets during cardiac surgery; however, this "one-size-fits-all" approach may not account for individual variability in cerebral perfusion requirements. This study proposes a personalized blood pressure management strategy based on real-time monitoring of cerebral autoregulation, with the goal of maintaining optimal cerebral perfusion and protecting the brain from both hypo- and hyper-perfusion
Read the detailed description
The primary aim of this pilot study is to evaluate the feasibility of conducting a subsequent definitive trial by assessing recruitment rates, protocol adherence, and the completeness and quality of short-term outcome data collection. The pilot study will also provide an opportunity to identify potential challenges and optimize the design of the larger trial, if necessary.
If the study hypothesis is confirmed and subsequently reproduced in larger, rigorous clinical trials, the findings could have important implications for intraoperative blood pressure management in elderly patients undergoing cardiac surgery. Specifically, this research may support a transition from the current "one-size-fits-all" blood pressure management strategy toward an individualized, real-time approach guided by cerebral autoregulation monitoring. Such a personalized strategy could potentially reduce the incidence of postoperative delirium (POD) in this high-risk population.
Conversely, premature implementation of personalized blood pressure management based solely on the currently available preliminary evidence may lead to unintended adverse consequences. Therefore, the proposed pilot study is essential to provide critical feasibility and safety data before proceeding to a larger definitive trial.
This study will be conducted as a prospective, single-centre, randomized controlled clinical trial comparing a real-time cerebral autoregulation monitoring-based blood pressure management strategy with standard care. Participants will be randomized into two groups:
Intervention Group: Blood pressure management guided by real-time cerebral autoregulation monitoring.
Control Group: Standard intraoperative blood pressure management according to current institutional practice.
- Conditions
- Delirium - Postoperative, Cardiac Surgery
- Being tested
- Mespere NeuroOs (Mespere Life Sciences) monitor
- Keywords
- Cerebral Autoregulation Monitoring
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mespere NeuroOs (Mespere Life Sciences) monitorDevice
bilateral Mespere NeuroOs cerebral oximeter sensors will be placed on the fronto-temporal area on the fronto-temporal area of all patients.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: | Experimental | Participants randomized to the intervention group will receive individualized intraoperative blood pressure management guided by real-time cerebral autoregulation monitoring to protect against both hypo- and hyper-cerebral perfusion.
Cerebral autoregulation will be assessed using the cerebral blood volume reactivity index (VRx), defined as the Pearson correlation coefficient between blood volume index (BVI) and mean arterial pressure (MAP). The lower and upper limits of autoregulation will be identified as the MAP values at which VRx exceeds 0.3.
If VRx remains outside the autoregulatory range for more than 60 seconds, the anesthesiologist may intervene to restore MAP within the individualized autoregulatory zone. The type and sequence of interventions will be at the discretion of the attending anesthesiologist. Receives: Device: Mespere NeuroOs (Mespere Life Sciences) monitor |
| Control Group: | Active comparator | In the control group, the cerebral oximetry monitor will be electronically blinded, although data will be continuously recorded for subsequent analysis. Intraoperative blood pressure management will follow current institutional standard practice at the discretion of the attending anesthesiologist. Receives: Device: Mespere NeuroOs (Mespere Life Sciences) monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
- Recruitment rate: Percentage of eligible patients enrolled in the study (feasibility target: >10%).
Measured: 2 year
Non-adherence with the protocol
Non-adherence with the protocol (percentage of patients with VRx > 0.3 where no intervention was performed; <10%)
Measured: 2 year
Completeness and quality of POD assessment
Completeness and quality of POD assessment (percent of patients for whom all CAM-ICU assessments are complete and conclusive; > 90%)
Measured: 2 year
Secondary outcomes (3)
Overall incidence of impaired cerebral autoregulation
Overall incidence of impaired cerebral autoregulation in the intervention and control groups.
Measured: 2 year
Percentage of patients in whom attempted restoration
Percentage of patients in whom attempted restoration of VRx to autoregulation range was unsuccessful
Measured: 2 year
The number of interventions required
The number of interventions required to restore VRx to autoregulation range
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (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 University Health Network, TorontoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a prospective, single-centre, randomized, controlled clinical trial comparing real-time cerebral autoregulation monitoring- based blood pressure management strategy to standard care. 2 Groups: Intervention and Control
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George Djaiani, Principal investigator, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671404
- Sponsor's protocol ID
- 25-5746
- Acronym
- AUTO-POD
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No plan yet
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Delirium After Cardiac Surgery: Personalized Targeted Blood Pressure Management Strategy Using Cerebral Autoregulation Monitoring: A Pilot Study
- ClinicalTrials.gov ID
- NCT07671404
- Acronym / sponsor ID
- AUTO-POD / 25-5746
- Conditions
- Delirium - Postoperative, Cardiac Surgery
- Keywords
- Cerebral Autoregulation Monitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 26 Jun 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.
Approximately one in four elderly patients develops postoperative delirium (POD) after cardiac surgery. POD is associated with prolonged hospitalization, increased mortality, and higher health care costs. While patient-related risk factors are often difficult to modify, surgery- and anesthesia-related factors may be optimized to reduce the incidence of POD. One potentially modifiable factor is intraoperative blood pressure management. Current practice commonly relies on standardized blood pressure targets during cardiac surgery; however, this "one-size-fits-all" approach may not account for individual variability in cerebral perfusion requirements. This study proposes a personalized blood pressure management strategy based on real-time monitoring of cerebral autoregulation, with the goal of maintaining optimal cerebral perfusion and protecting the brain from both hypo- and hyper-perfusion
Detailed description
The primary aim of this pilot study is to evaluate the feasibility of conducting a subsequent definitive trial by assessing recruitment rates, protocol adherence, and the completeness and quality of short-term outcome data collection. The pilot study will also provide an opportunity to identify potential challenges and optimize the design of the larger trial, if necessary.
If the study hypothesis is confirmed and subsequently reproduced in larger, rigorous clinical trials, the findings could have important implications for intraoperative blood pressure management in elderly patients undergoing cardiac surgery. Specifically, this research may support a transition from the current "one-size-fits-all" blood pressure management strategy toward an individualized, real-time approach guided by cerebral autoregulation monitoring. Such a personalized strategy could potentially reduce the incidence of postoperative delirium (POD) in this high-risk population.
Conversely, premature implementation of personalized blood pressure management based solely on the currently available preliminary evidence may lead to unintended adverse consequences. Therefore, the proposed pilot study is essential to provide critical feasibility and safety data before proceeding to a larger definitive trial.
This study will be conducted as a prospective, single-centre, randomized controlled clinical trial comparing a real-time cerebral autoregulation monitoring-based blood pressure management strategy with standard care. Participants will be randomized into two groups:
Intervention Group: Blood pressure management guided by real-time cerebral autoregulation monitoring.
Control Group: Standard intraoperative blood pressure management according to current institutional practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a prospective, single-centre, randomized, controlled clinical trial comparing real-time cerebral autoregulation monitoring- based blood pressure management strategy to standard care. 2 Groups: Intervention and Control
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: | Experimental | Device: Mespere NeuroOs (Mespere Life Sciences) monitorParticipants randomized to the intervention group will receive individualized intraoperative blood pressure management guided by real-time cerebral autoregulation monitoring to protect against both hypo- and hyper-cerebral perfusion. Cerebral autoregulation will be assessed using the cerebral blood volume reactivity index (VRx), defined as the Pearson correlation coefficient between blood volume index (BVI) and mean arterial pressure (MAP). The lower and upper limits of autoregulation will be identified as the MAP values at which VRx exceeds 0.3. If VRx remains outside the autoregulatory range for more than 60 seconds, the anesthesiologist may intervene to restore MAP within the individualized autoregulatory zone. The type and sequence of interventions will be at the discretion of the attending anesthesiologist. |
| Control Group: | Active comparator | Device: Mespere NeuroOs (Mespere Life Sciences) monitorIn the control group, the cerebral oximetry monitor will be electronically blinded, although data will be continuously recorded for subsequent analysis. Intraoperative blood pressure management will follow current institutional standard practice at the discretion of the attending anesthesiologist. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consenting patients aged ≥ 60 years undergoing elective complex cardiac surgery (coronary artery bypass grafting plus valve surgery, double-valve surgery, triple-valve surgery, redo operations, or aortic arch surgery), or patients aged ≥ 70 years undergoing isolated coronary artery bypass grafting or single-valve repair/replacement surgery.
Key exclusion criteria (4 listed)
- Patients with symptomatic cerebrovascular disease.
- History of delirium.
- Major neurocognitive impairment (e.g., dementia or Mini-Mental State Examination score < 10).
- Schizophrenia.
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 |
|---|---|---|
| Mespere NeuroOs (Mespere Life Sciences) monitorbilateral Mespere NeuroOs cerebral oximeter sensors will be placed on the fronto-temporal area on the fronto-temporal area of all patients. | Device | Control Group:, Intervention Group: |
Primary outcome
Recruitment rate
Time frame: 2 year
1. Recruitment rate: Percentage of eligible patients enrolled in the study (feasibility target: >10%).
Non-adherence with the protocol
Time frame: 2 year
Non-adherence with the protocol (percentage of patients with VRx > 0.3 where no intervention was performed; <10%)
Completeness and quality of POD assessment
Time frame: 2 year
Completeness and quality of POD assessment (percent of patients for whom all CAM-ICU assessments are complete and conclusive; > 90%)
3 secondary outcomes
Overall incidence of impaired cerebral autoregulation
Time frame: 2 year
Percentage of patients in whom attempted restoration
Time frame: 2 year
The number of interventions required
Time frame: 2 year
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 26 Jun 2026.
- Individual participant dataSharing planned: Undecided. No plan yet
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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.
George Djaiani principal investigator
Toronto General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Mespere NeuroOs (Mespere Life Sciences) monitor in people with Delirium - Postoperative and Cardiac Surgery, run by University Health Network, Toronto.
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 4 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 26 Jun 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?
Contact George Djaiani, MD FRCAFRCPS (416-340-4800 ext. 6205, george.djaiani@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 2 year). The study lists 3 primary outcomes in all. 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 26 Jun 2026.