Cerebral Autoregulation and Delirium Study

NCT07671404 | Not Yet Recruiting

• 1 other identifier: 25-5746
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

Delirium - Postoperative; Cardiac Surgery

Keywords

Cerebral Autoregulation Monitoring

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  1\. Recruitment rate: Percentage of eligible patients enrolled in the study (feasibility target: \>10%).

  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%)

  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%)

  2 year

Secondary Outcomes (3)

• Overall incidence of impaired cerebral autoregulation

  2 year

• Percentage of patients in whom attempted restoration

  2 year

• The number of interventions required

  2 year

Other Outcomes (3)

• Tertiary Outcomes: . Frequency of POD

  2 year

• Tertiary Outcomes: A composite outcome of major end organ dysfunction

  2 year

• Tertiary Outcomes: Postoperative quality of recovery

  2 year

Study Arms (2)

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.

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.

Device: Mespere NeuroOs (Mespere Life Sciences) monitor

Interventions

Mespere NeuroOs (Mespere Life Sciences) monitor DEVICE

bilateral Mespere NeuroOs cerebral oximeter sensors will be placed on the fronto-temporal area on the fronto-temporal area of all patients.

Control Group:; Intervention Group:

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with symptomatic cerebrovascular disease.
• History of delirium.
• Major neurocognitive impairment (e.g., dementia or Mini-Mental State Examination score \< 10).
• Schizophrenia.

Sponsors & Collaborators

• University Health Network, Toronto: lead

MeSH Terms

Conditions

Emergence Delirium

Interventions

Monitoring, Physiologic

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• George Djaiani

  Toronto General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George Djaiani, MD FRCAFRCPS

CONTACT

416-340-4800; george.djaiani@uhn.ca

Deep Grewal

CONTACT

416-340-4800; deep.grewal@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Intervention group or the control group (1:1 ratio). Prior to anesthesia induction, bilateral Mespere NeuroOs cerebral oximeter sensors will be placed on the fronto-temporal area of all patients. In the intervention group, cerebral autoregulation will be monitored intra-operatively for the duration of surgery. In the control group, the cerebral oximetry monitor will be electronically blinded, but data will be continuously recorded and stored for later analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 26, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 26, 2026

Record last verified: 2026-05