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NCT Number: NCT07671404

Cerebral Autoregulation and Delirium 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

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Key information

Conditions

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

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Recruitment rate

    Time frame: 2 year

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

  2. 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%)

  3. 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%)

Secondary outcomes

  1. Overall incidence of impaired cerebral autoregulation

    Time frame: 2 year

    Overall incidence of impaired cerebral autoregulation in the intervention and control groups.

  2. Percentage of patients in whom attempted restoration

    Time frame: 2 year

    Percentage of patients in whom attempted restoration of VRx to autoregulation range was unsuccessful

  3. The number of interventions required

    Time frame: 2 year

    The number of interventions required to restore VRx to autoregulation range

Other outcomes

  1. Tertiary Outcomes: . Frequency of POD

    Time frame: 2 year

    Frequency of postoperative delirium (POD) up to postoperative day 3 in both study groups (primary outcome for the definitive trial).

  2. Tertiary Outcomes: A composite outcome of major end organ dysfunction

    Time frame: 2 year

    A composite outcome of major end organ dysfunction defined as major organ morbidity and mortality (MOMM) and all cause 30-day mortality.

  3. Tertiary Outcomes: Postoperative quality of recovery

    Time frame: 2 year

    Postoperative quality of recovery score QoR-15 survey will be performed at baseline, and postoperative days 1 to 3 (or discharge if earlier).

Study contacts

Contact information is provided by the study sponsor or research team.

Deep Grewal

CONTACT

[email protected]

416-340-4800 ext. 4221

George Djaiani, MD FRCAFRCPS

CONTACT

[email protected]

416-340-4800 ext. 6205

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Reducing Delirium After Cardiac Surgery: Personalized Targeted Blood Pressure Management Strategy Using Cerebral Autoregulation Monitoring: A Pilot Study

Acronym: AUTO-POD

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 26, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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