Optimizing Cerebral Autoregulation During Surgery

Not Applicable

Active, not recruiting

• Conditions: Surgery; Delirium; Hip Fractures; Hip Arthropathy

• Registration Number: NCT05308290
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-24
• Study First Submitted QC: 2022-03-24
• Study First Posted: 2022-04-04
• Study Start: 2023-01-09
• Primary Completion: 2024-06-28
• Status Verified: 2025-06
• Results First Submitted: 2025-06-27
• Results First Submitted QC: 2025-06-27
• Last Update Submitted: 2025-06-27
• Results First Posted: 2025-07-16
• Last Update Posted: 2025-07-16
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean Arterial Pressure Outside Limits of Cerebral Autoregulation	Intraoperative, up to 5 hours	Extent (mmHg \* hours) of mean arterial pressure outside limits of cerebral autoregulation after establishment of target mean arterial pressure.
Estimated Blood Loss	Intraoperative, up to 5 hours	Blood loss during surgery (mL).
Number of Participants With New Myocardial Infarction After Surgery	In the hospital after surgery, up to 2 weeks	Clinically diagnosed new myocardial infarction after surgery as a measure of incidence.
Number of Participants With New Stroke After Surgery	In the hospital after surgery, up to 2 weeks	Clinically diagnosed new stroke after surgery as a measure of incidence.

Secondary Outcome Measures

Name	Time	Method
Number of Participants That Develop Delirium After Surgery	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.
Change in General Function as Assessed by the Instrumental Activities of Daily Living Questionnaire	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.
Change in General Cognitive Function as Assessed by the Short Blessed Test	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.
Dementia Screening as Assessed by the AD8 Test	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
Change in Ability to Ambulate Without Human Assistance	Approximately 60, 180, and 365 Days after Surgery	Inability to walk more than 10 feet without human assistance.
Change in Executive Cognitive Function as Assessed by the Oral Trail Making Test	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.
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	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.

Trial Locations

Locations (1)

The Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States