Optimizing Cerebral Autoregulation During Surgery

Not Applicable

Recruiting

• Conditions: Surgery; Delirium; Hip Fractures; Hip Arthropathy
• Interventions: Other: Blood pressure management according to cerebral autoregulation; Other: Blood pressure management according to usual care

• 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
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-09-12
• Study Completion: 2025-09-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 77

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blood pressure managed by cerebral autoregulation	Blood pressure management according to 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.
Standard of care blood pressure management	Blood pressure management according to usual care	In this arm cerebral autoregulation monitoring will be used for observation. The anesthesia provider will use usual care guidelines for blood pressure management.

Primary Outcome Measures

Name	Time	Method
Estimated Blood Loss	Intraoperative, up to 5 hours	Blood loss during surgery (mL).
Mean arterial pressure outside limits of cerebral autoregulation	Intraoperative, up to 5 hours	Extent (mmHg X hours) of mean arterial pressure outside limits of cerebral autoregulation after establishment of target mean arterial pressure.
Incidence of new Stroke after surgery	In the hospital after surgery, up to 1 week	Clinically diagnosed new stroke after surgery.
Incidence of new Myocardial Infarction after surgery	In the hospital after surgery, up to 1 week	Clinically diagnosed new myocardial infarction after surgery.

Secondary Outcome Measures

Name	Time	Method
Dementia Screening as assessed by the AD8 test	365 Days after Surgery	Will be assessed via AD8. Scores range from 0-8 with 0 indicating no cognitive impairment and 8 indicating severe cognitive impairment consistent with dementia
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 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.
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.
Number of participants that develop delirium after surgery	In the hospital during the first 3 days after surgery	Delirium as diagnosed by the 3D-CAM or CAM-ICU.
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.
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.

Trial Locations

Locations (1)

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