Optimizing Cerebral Autoregulation During Surgery

NCT ID: NCT05308290

Last Updated: 2025-09-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-09

Study Completion Date

2025-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hip Fractures Hip Arthropathy Surgery Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Blood pressure management according to cerebral autoregulation

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Blood pressure management according to usual care

Intervention Type OTHER

Intraoperative blood pressure will be targeted based on usual care.

Interventions

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Blood pressure management according to cerebral autoregulation

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

Intervention Type OTHER

Blood pressure management according to usual care

Intraoperative blood pressure will be targeted based on usual care.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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The Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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K76AG057020

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00137091

Identifier Type: -

Identifier Source: org_study_id

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