Optimizing Cerebral Autoregulation During Surgery

NCT05308290 | Completed Results

• 2 other identifiers: IRB00137091K76AG057020
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Fractures; Hip Arthropathy; Surgery; Delirium

Outcome Measures

Primary Outcomes (4)

• 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

• Estimated Blood Loss

  Blood loss during surgery (mL).

  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 Outcomes (7)

• Number of Participants That Develop Delirium After Surgery

  In the hospital during the first 3 days after surgery

• Change in General Cognitive Function as Assessed by the Short Blessed Test

  Approximately 60, 180, and 365 Days after Surgery

• Change in Executive Cognitive Function as Assessed by the Oral Trail Making Test

  Approximately 60, 180, and 365 Days after Surgery

• Dementia Screening as Assessed by the AD8 Test

  365 Days after Surgery

• Change in General Overall Health and Disability as Assessed by the WHO Disability Assessment Schedule 2.0

  Approximately 60, 180, and 365 Days after Surgery

Study Arms (2)

Blood pressure managed by cerebral autoregulation

EXPERIMENTAL

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

Standard of care blood pressure management

ACTIVE COMPARATOR

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

Interventions

Blood pressure management according to cerebral autoregulation OTHER

Intraoperative blood pressure will be targeted based on limits of cerebral autoregulation.

Blood pressure managed by cerebral autoregulation

Blood pressure management according to usual care OTHER

Intraoperative blood pressure will be targeted based on usual care.

Standard of care blood pressure management

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• planned hip or knee surgery (either for fracture or elective) or lung surgery
• age ≥60
• ambulatory at baseline
• expected duration of surgery \> 90 minutes

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

The Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Hip Fractures; Delirium

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Charles Brown, MD PhD
• Organization: Stanford University

chbrown@stanford.edu

6504983512

Study Officials

• Charles Brown, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 4, 2022
• Study Start: January 9, 2023
• Primary Completion: June 28, 2024
• Study Completion: July 30, 2025
• Last Updated: September 2, 2025
• Results First Posted: July 16, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)