Optimizing Cerebral Autoregulation During Surgery

Study Overview
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Brief Summary
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The purpose of this study is to conduct a pilot trial to determine the feasibility, safety, and potential efficacy of targeting MAP within the limits of cerebral autoregulation during surgery compared with usual care.

Official Title
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Optimizing Cerebral Autoregulation During Surgery

Conditions
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Hip Arthropathy, Surgery, Delirium, Hip Fractures

Intervention / Treatment
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* Other: Blood pressure management according to cerebral autoregulation
* Other: Blood pressure management according to usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: planned hip or knee surgery (either for fracture or elective) or lung surgery age ≥60 ambulatory at baseline expected duration of surgery > 90 minutes Exclusion Criteria: Planned concurrent surgery Allergy to adhesive tape Short Blessed Test score >20 Clinical diagnosis of dementia Opinion of either the anesthesiologist or surgeon that the patient is not appropriate.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood pressure managed by cerebral autoregulation<br>In this arm cerebral autoregulation monitoring will be used to determine the lower and upper limits of cerebral autoregulation. Monitoring will continue throughout the surgery. Blood pressure management will be maintained to be within the limits of cerebral autoregulation. | Other: Blood pressure management according to cerebral autoregulation<br>* Intraoperative blood pressure will be targeted based on limits of cerebral autoregulation.<br>|
| Active Comparator: Standard of care blood pressure management<br>In this arm cerebral autoregulation monitoring will be used for observation. The anesthesia provider will use usual care guidelines for blood pressure management. | Other: Blood pressure management according to usual care<br>* Intraoperative blood pressure will be targeted based on usual care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean arterial pressure outside limits of cerebral autoregulation | Extent (mmHg X hours) of mean arterial pressure outside limits of cerebral autoregulation after establishment of target mean arterial pressure. | Intraoperative, up to 5 hours | 
| Estimated Blood Loss | Blood loss during surgery (mL). | Intraoperative, up to 5 hours | 
| Incidence of new Myocardial Infarction after surgery | Clinically diagnosed new myocardial infarction after surgery. | In the hospital after surgery, up to 1 week | 
| Incidence of new Stroke after surgery | Clinically diagnosed new stroke after surgery. | In the hospital after surgery, up to 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that develop delirium after surgery | Delirium as diagnosed by the 3D-CAM or CAM-ICU. | In the hospital during the first 3 days after surgery | 
| Change in general Cognitive Function as assessed by the Short Blessed Test | Will be assessed via Short Blessed Test. Scores range from 0-28 with 0 indicating no cognitive impairment and 28 indicating severe cognitive impairment. | Approximately 60, 180, and 365 Days after Surgery | 
| Change in Executive Cognitive Function as assessed by the Oral Trail Making Test | Will be assessed via Oral Trail Making Test. The test is timed, and shorter times indicate better performance and longer times indicate worse performance. | Approximately 60, 180, and 365 Days after Surgery | 
| Dementia Screening as assessed by the AD8 test | Will be assessed via AD8. Scores range from 0-8 with 0 indicating no cognitive impairment and 8 indicating severe cognitive impairment consistent with dementia | 365 Days after Surgery | 
| Change in general overall health and Disability as assessed by the WHO Disability Assessment Schedule 2.0 | Will be assessed via the World Health Organization (WHO) Disability Assessment Schedule 2.0 (WHO-DAS 2.0). Scores range from 0-100 with 0 indicating no disability and 100 indicating severe disability. | Approximately 60, 180, and 365 Days after Surgery | 
| Change in General function as assessed by the Instrumental Activities of Daily Living questionnaire | Score on Instrumental Activities of Daily Living. Scores range from 0-8, with 0 indicating severe impairment and 8 indicating no impairment. | Approximately 60, 180, and 365 Days after Surgery | 
| Change in ability to Ambulate without human assistance | Inability to walk more than 10 feet without human assistance. | Approximately 60, 180, and 365 Days after Surgery |