Cerebral Autoregulation and Delirium Study

ConditionsDelirium - Postoperative Cardiac Surgery

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age60+

SponsorUniversity Health Network, Toronto

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Patients with symptomatic cerebrovascular disease.

History of delirium.

Major neurocognitive impairment (e.g., dementia or Mini-Mental State Examination score < 10).

Schizophrenia.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Intervention Group:Experimental treatment 1 intervention

Group B: Control Group:Active comparator 1 intervention

Trial outcomes

Primary outcomes

Recruitment rate

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

Time frame

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%)

Time frame

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%)

Time frame

2 year

Secondary outcomes

Overall incidence of impaired cerebral autoregulation

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

Time frame

2 year

Percentage of patients in whom attempted restoration

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

Time frame

2 year

The number of interventions required

The number of interventions required to restore VRx to autoregulation range

Time frame

2 year

Other outcomes

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).

Time frame

2 year

Tertiary Outcomes: A composite outcome of major end organ dysfunction

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

Time frame

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).

Time frame

2 year

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov

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