Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall incidence of impaired cerebral autoregulation | Overall incidence of impaired cerebral autoregulation in the intervention and control groups. | 2 year |
| Percentage of patients in whom attempted restoration |
| Measure | Description | Time Frame |
|---|---|---|
| Tertiary Outcomes: . Frequency of POD | Frequency of postoperative delirium (POD) up to postoperative day 3 in both study groups (primary outcome for the definitive trial). | 2 year |
| Tertiary Outcomes: A composite outcome of major end organ dysfunction |
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| George Djaiani, MD FRCAFRCPS | Contact | 416-340-4800 | 6205 | george.djaiani@uhn.ca |
| Deep Grewal | Contact | 416-340-4800 | 4221 | deep.grewal@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| George Djaiani | Toronto General Hospital | Principal Investigator |
Not provided
No plan yet
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
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
Not provided
Not provided
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.
Percentage of patients in whom attempted restoration of VRx to autoregulation range was unsuccessful
| 2 year |
| The number of interventions required | The number of interventions required to restore VRx to autoregulation range | 2 year |
A composite outcome of major end organ dysfunction defined as major organ morbidity and mortality (MOMM) and all cause 30-day mortality.
| 2 year |
| Tertiary Outcomes: Postoperative quality of recovery | Postoperative quality of recovery score QoR-15 survey will be performed at baseline, and postoperative days 1 to 3 (or discharge if earlier). | 2 year |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |