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Completed

NCT Number: NCT05308290

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.

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Key information

Conditions

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

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Johns Hopkins University

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood pressure management according to cerebral autoregulation

Other

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

Blood pressure management according to usual care

Other

Intraoperative blood pressure will be targeted based on usual care.

Primary outcomes

  1. Mean Arterial Pressure Outside Limits of Cerebral Autoregulation

    Time frame: Intraoperative, up to 5 hours

    Extent (mmHg * hours) of mean arterial pressure outside limits of cerebral autoregulation after establishment of target mean arterial pressure.

  2. Estimated Blood Loss

    Time frame: Intraoperative, up to 5 hours

    Blood loss during surgery (mL).

  3. Number of Participants With New Myocardial Infarction After Surgery

    Time frame: In the hospital after surgery, up to 2 weeks

    Clinically diagnosed new myocardial infarction after surgery as a measure of incidence.

  4. Number of Participants With New Stroke After Surgery

    Time frame: In the hospital after surgery, up to 2 weeks

    Clinically diagnosed new stroke after surgery as a measure of incidence.

Secondary outcomes

  1. Number of Participants That Develop Delirium After Surgery

    Time frame: In the hospital during the first 3 days after surgery

    Development of delirium after surgery as diagnosed by the 3-Minute, Diagnostic Interview for Confusion Assessment Method (3D-CAM) or CAM-ICU.

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

    Time frame: Approximately 60, 180, and 365 Days after Surgery

    Will be assessed via Short Blessed Test. Scores range from 0-28 with 0 indicating no cognitive impairment and 28 indicating severe cognitive impairment.

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

    Time frame: Approximately 60, 180, and 365 Days after Surgery

    Will be assessed via Oral Trail Making Test. The test is timed, and shorter times indicate better performance and longer times indicate worse performance.

  4. Dementia Screening as Assessed by the AD8 Test

    Time frame: 365 Days after Surgery

    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

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

    Time frame: Approximately 60, 180, and 365 Days after Surgery

    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.

  6. Change in General Function as Assessed by the Instrumental Activities of Daily Living Questionnaire

    Time frame: Approximately 60, 180, and 365 Days after Surgery

    Score on Instrumental Activities of Daily Living. Scores range from 0-8, with 0 indicating severe impairment and 8 indicating no impairment.

  7. Change in Ability to Ambulate Without Human Assistance

    Time frame: Approximately 60, 180, and 365 Days after Surgery

    Inability to walk more than 10 feet without human assistance.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 4, 2022
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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