The purpose of this study is to conduct a pilot trial to determine the feasibility, safety, and potential efficacy of targeting mean arterial blood pressure (MAP) within the limits of cerebral autoregulation during surgery compared with usual care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
27
Intraoperative blood pressure will be targeted based on limits of cerebral autoregulation.
Intraoperative blood pressure will be targeted based on usual care.
The Johns Hopkins University
Baltimore, Maryland, United States
Mean Arterial Pressure Outside Limits of Cerebral Autoregulation
Extent (mmHg \* hours) of mean arterial pressure outside limits of cerebral autoregulation after establishment of target mean arterial pressure.
Time frame: Intraoperative, up to 5 hours
Estimated Blood Loss
Blood loss during surgery (mL).
Time frame: Intraoperative, up to 5 hours
Number of Participants With New Myocardial Infarction After Surgery
Clinically diagnosed new myocardial infarction after surgery as a measure of incidence.
Time frame: In the hospital after surgery, up to 2 weeks
Number of Participants With New Stroke After Surgery
Clinically diagnosed new stroke after surgery as a measure of incidence.
Time frame: In the hospital after surgery, up to 2 weeks
Number of Participants That Develop Delirium After Surgery
Development of delirium after surgery as diagnosed by the 3-Minute, Diagnostic Interview for Confusion Assessment Method (3D-CAM) or CAM-ICU.
Time frame: 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.
Time frame: Approximately 60, 180, and 365 Days after Surgery
Change in Executive Cognitive Function as Assessed by the Oral Trail Making Test
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Will be assessed via Oral Trail Making Test. The test is timed, and shorter times indicate better performance and longer times indicate worse performance.
Time frame: Approximately 60, 180, and 365 Days after Surgery
Dementia Screening as Assessed by the AD8 Test
Will be assessed via the Eight-item Interview to Differentiate Aging and Dementia Test (AD8). Scores range from 0-8 with 0 indicating no cognitive impairment and 8 indicating severe cognitive impairment consistent with dementia
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Approximately 60, 180, and 365 Days after Surgery