Optimizing Cerebral Autoregulation During Surgery

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 Overview

• Status: Completed
• Conditions: Delirium; Surgery; Hip Fractures; Hip Arthropathy
• Intervention / Treatment: Other: Blood pressure management according to cerebral autoregulation; Other: Blood pressure management according to usual care

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • The Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood pressure managed by cerebral autoregulation; 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; Intraoperative blood pressure will be targeted based on limits of cerebral autoregulation.
Active Comparator: Standard of care blood pressure management; 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; Intraoperative blood pressure will be targeted based on usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated Blood Loss	Blood loss during surgery (mL).	Intraoperative, up to 5 hours
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.	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.	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.	In the hospital after surgery, up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 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	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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Charles Brown, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Actual): June 28, 2024
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Wounds and Injuries; Leg Injuries; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Fractures, Bone; Femoral Fractures; Hip Injuries; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Delirium; Hip Fractures
• Other Study ID Numbers: IRB00137091; K76AG057020 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No